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610th Edition, May 29, 2024

By BHI Weekly News Archives

 

Celebrating Excellence: Maryland Tech Council 2024 ICON Award Winners 

BioHealth Innovation Inc. (BHI) congratulates the outstanding winners of the 2024 ICON Awards announced by the Maryland Tech Council. These awards recognize the incredible contributions of individuals and companies in the fields of technology and life sciences, highlighting their impact on millions of lives.

AstraZeneca: with a member of our BHI Board of Directors, Tyrell Rivers, Ph.D., has been honored as the Life Science Company of the Year. Their continued dedication to advancing healthcare through groundbreaking research and development is truly commendable.

Nanochon: We are particularly proud of Nanochon and Benjamin Holmes, the recipients of the Chief Executive Officer of the Year—Life Sciences award. Nanochon is a previous winner of our BioHealth Capital Region Crab Trap, and it’s exciting to see their sustained excellence and innovation being recognized on a larger stage.

Solaxa: A special congratulations to Solaxa, who was awarded the Venture Mentoring Services Venture of the Year. We are pleased to note that two members of Solaxa’s leadership team, Luis T. Gutierrez, Jr. and Jennifer Butler, are part of the BHI/Montgomery County Executive-In-Residence Program. This recognition underscores their remarkable leadership and commitment to advancing technology and life sciences.

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Rockville’s Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) — Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.

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Supernus Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in Epilepsy

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as finding effective doses in various treatment-resistant seizure types. The interim analysis is as of May 1, 2024, and is based on 41 enrolled subjects, of which 19 completed the maintenance period. Of these 19 subjects, 16 subjects had focal seizures.

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Activation Capital Introduces ‘Frontier BioHealth’ to Catalyze Life Science Startups

RICHMOND, Va., May 23, 2024 /PRNewswire/ — Activation Capital announces the launch of Frontier BioHealth, an educational and support program designed to provide highly specialized training, targeted mentorship, and relationship building to help scale pharmaceutical, biotech, medical device, and health-focused consumer products companies. The inaugural four-month program will be critical in bringing research-intense products and companies to market. It will broaden the continuum of regional early-stage support – additive to Virginia Commonwealth University’s proof of concept fund and newly launched pre-accelerator program – and continue to coalesce the emerging private investment ecosystem in Central Virginia.

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PQE Group US Earns Great Place to Work Certification™

Rockville, MD, May 22, 2024. PQE Group is proud to announce that, for the third consecutive year, its US subsidiary has been Certified™ by Great Place To Work®. This prestigious award is based entirely on what current employees say about their experience working at PQE Group US. This year, 85% of employees in the US said it’s a great place to work, 28% higher than the average U.S. company.

Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. To obtain this recognition, PQE Group’s US employees completed a voluntary survey, responding to numerous questions regarding their satisfaction in a wide array of areas that encompass the framework of PQE Group’s company culture.

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Frederick’s Theradaptive Secures $1M in Funding from Maryland Stem Cell Research Fund for Human Clinical Trials

FREDERICK, Md., May 22, 2024 /PRNewswire/ — Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP.  OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.

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Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis

GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”).

Descartes-08, the Company’s lead product candidate, is an autologous mRNA CAR-T directed against the B cell maturation antigen (“BCMA”) initially being developed for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue.

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MaxCyte Signs Strategic Platform License Agreement with Legend Biotech to Accelerate Cell Therapy Discovery and Development

Legend Biotech obtains license to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support its non-viral engineered pipeline portfolio across a variety of cell types including T cells, Gamma-Delta T cells and NK Cells.

ROCKVILLE, Md., May 22, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development, and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced it has entered into a strategic platform license (SPL) agreement with Legend Biotech, a global leader in cell therapy.

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Nona Biosciences Announces Global License and Option Agreement with AstraZeneca for Monoclonal Antibody to be Developed into Novel Tumor Targeted Therapies

Nona Biosciences, a global biotechnology company providing a total solution from “Idea to IND” (I to ITM), ranging from target validation and antibody discovery through preclinical research, announced today that it has entered into a license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology.

Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction. Nona is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona is eligible to receive payments for the option programs should AstraZeneca exercise these options.

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Welldoc Certified as a Great Place to Work® for Third Year in a Row

COLUMBIA, Md., May 21, 2024 — Welldoc®, a leading digital health company specializing in AI-driven cardiometabolic health, announced today that it was Certified™ by Great Place to Work® for the third consecutive year. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 90 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 31 points.

Great Place to Work is the global authority on workplace culture, known for its expertise in employee experience and leadership practices that drive business success. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.

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609th Edition, May 21, 2024

By BHI Weekly News Archives

 

Save the Dates: 2024 BioHealth Capital Region Week Registration Coming Soon 

Looking forward to the Autumn of 2024, the BioHealth Capital Region is gearing up for three major events, September 17th, 18th, and 19th, 2024, that promise to bring together industry leaders, investors, and innovators from across the biopharma and healthcare sectors. Whether you’re a company seeking investment, an entrepreneur ready to showcase your innovations, or an industry professional looking to network and gain insights, these events are not to be missed. Mark your calendars and stay tuned as registration and application sites will be going live soon.

10th Annual BioHealth Capital Region Forum

Dates: September 17-18, 2024
Venue: US Pharmacopeia, Rockville, MD

Celebrate a decade of achievements and advancements at the 10th Annual BioHealth Capital Region Forum. This milestone event will reflect on ten years of progress within the BioHealth sector and set the stage for future innovations. Attendees will have the opportunity to engage in meaningful discussions, participate in networking sessions, and connect with hundreds of C-level executives from government, academia, and industry. If you’re looking to stay on the cutting edge of biopharma developments, this is the place to be.

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Explore a Career in Life Sciences Business Strategy with BioHealth Innovation, Inc.

Are you a recent PhD graduate eager to blend your scientific expertise with business acumen? BioHealth Innovation, Inc. (BHI) is looking for an Entry-Level Life Sciences Business Strategist to join their team. This remote opportunity is ideal for early-career scientists passionate about accelerating the adoption of new technologies to improve lives.

What Will You Do? As a Business Strategist at BHI, you’ll support growth-stage businesses by developing commercialization plans and crafting federal grant proposals. You’ll also engage with expert Entrepreneurs-In-Residence and other professionals, fostering relationships that drive the commercial potential of emerging technologies in fields like therapeutics and medical devices.

Who Should Apply? If you hold a Ph.D. in biological sciences and have strong writing and analytical skills, you might be the perfect candidate. We’re looking for driven individuals who are adept at managing multiple projects and keen on making a significant impact in the biohealth industry.

Why BHI? Joining BHI means you’ll be part of a team dedicated to growing the BioHealth Capital Region through innovative commercialization strategies. This position offers a unique chance to develop your career at the intersection of science and business, engaging with key stakeholders across the industry.

Interested in making a difference in the biohealth sector? Learn more about this exciting opportunity and how to apply by clicking here. Join BHI and help shape the future of BioHealth.

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Baltimore Fishbowl: MCB Real Estate announces plans for a mixed-use development in Montgomery County that will have a focus on the life sciences and biohealth

MCB Real Estate, the developer of Harborplace in Baltimore, announced on Thursday that it will lead the development of VIVA White Oak, a mixed use project planned for a 280-acre site in eastern Montgomery County, Maryland.

The land, near US 29 and Cherry Hill Road, is next to the U. S. Food and Drug Administration headquarters and near the Adventist HealthCare White Oak Medical Center. It’s also close to the University of Maryland’s College Park campus, the Interstate 95 corridor and BWI Thurgood Marshall International Airport. County officials have approved it for more than 12 million square feet of mixed-use development.

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Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness

WASHINGTON, May 15, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. This Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.).

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Maryland Stem Cell Research Commission Announces $15.4 Million in Awards to Accelerate Cures

48 scientists receive funding from the Maryland Stem Cell Research Fund to further research

COLUMBIA, Md. (May 14, 2024)—The Maryland Stem Cell Research Commission (“Commission”) is pleased to announce the next round of awards granting a total of more than $15.4 million. These awards are aimed at fostering groundbreaking research to enhance and propel stem cell treatments and technologies across Maryland.

Several esteemed scientists from various Maryland-based research institutions and companies have been selected as recipients in this grant cycle. Among the 48 distinguished awardees are academic researchers from prestigious institutions such as Johns Hopkins University; University of Maryland, Baltimore: University of Maryland, College Park; Lieber Institute for Brain Development; and the Hugo W. Moser Research Institute at Kennedy Krieger. Commercial sector entities like Seraxis Inc., Theradaptive, Inc., HOHCells, LLC, Agnos Therapeutics, Inc., and Reprocell U.S.A., Inc. were also awarded grants.

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Gaithersburg’s Amplexd Therapeutics, Innovating to Revolutionize the Future of Non-Invasive HPV-induced Cervical Intraepithelial Neoplasia (CIN) Treatments for the Prevention of Cervical Cancer: Developed by Women for Women

GAITHERSBURG, MD, May 20, 2024 (GLOBE NEWSWIRE) — Amplexd Therapeutics, Inc. (“Amplexd” or the “Company”), a clinical stage patient-scientist-led biotech company specializing in accessible treatments for human papillomavirus (HPV)-induced Cervical Intraepithelial Neoplasia (CIN), is pleased to announce major updates in 2024 toward the finalization of product development ahead of Phase 1/2 clinical trials for its non-invasive treatments of CIN, the precursor to cervical cancer. The Company has secured US$2 Million for this initiative from an Asia-based life sciences focused family office. “The funding marks a major milestone in our R&D efforts for our two therapies after extremely promising preclinical studies were completed. The capital will enable us to finalize development and IND submissions ahead of first-in-human clinical trials, expected to commence later this year,” said Co-Founder and CEO Alia Rahman.

The strategic funding positions Amplexd Therapeutics to reshape the landscape in HPV and cervical precancer treatments with two topical, non-invasive options as potential alternatives to the “watch and wait” approach for low-grade CIN, and invasive surgery for high-grade CIN. Amplexd is poised to move the needle with the development of two low-cost therapies that favor patient comfort and increase access, and a vision to provide accessible solutions to target the often-overlooked public health crisis of HPV-induced cervical precancers.

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Sands Capital’s Pulse Fund III Secures $555M Close

The Life Sciences Pulse strategy partners with private companies helping transform how diseases are defined, diagnosed, and treated.

Sands Capital is pleased to announce the close of our third life sciences fund, Sands Capital Life Sciences Pulse Fund III (“Pulse III”), raising $555 million. Pulse III was met with high demand from both existing and new limited partners. This close increases total Pulse strategy capital commitments to $1.3 billion, including Sands Capital Life Sciences Pulse Fund (“Pulse I”) and Sands Capital Life Sciences Pulse Fund II (“Pulse II”). The team will continue investing with the same emphasis on private therapeutics, diagnostics, medical devices, and life sciences tools businesses, in support of the strategy’s mission to help transform how diseases are defined, diagnosed, and treated.

“The life sciences sector continues to innovate at a rapid pace, leading to breakthroughs that benefit both patients and society as a whole,” said Stephen Zachary, Managing Partner. “We are grateful to both the investors joining us in Pulse III and the talented management teams we’ve partnered with since the strategy’s inception.”

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608th Edition, May 14, 2024

By BHI Weekly News Archives

 

Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines 

GAITHERSBURG, Md., May 10, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, has entered into a co-exclusive licensing agreement with Sanofi (Nasdaq: SNY).

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines while Novavax retains the right to and is developing its own COVID-19-Influenza Combination vaccine candidate; a non-exclusive license to use Novavax’s adjuvanted COVID-19 vaccine for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

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NextStep Robotics Wins Pitch Dingman Competition Grand Prize, Announces New Board Members

BALTIMORE, MD – May 13, 2024 – NextStep Robotics, a University of Maryland, Baltimore (UMB) spinout company dedicated to commercializing cutting-edge stroke rehabilitation technologies, was awarded the $20,000 Grand Prize in the 2024 Pitch Dingman Competition’s All Stars Track. The signature annual competition is hosted by the Dingman Center for Entrepreneurship, part of the Robert H. Smith School of Business at the University of Maryland, College Park.

NextStep is also pleased to announce the appointment of new board members. These expert business executives bring a wealth of experience in the healthcare and technology sectors, which will be invaluable as NextStep Robotics continues to grow.

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Linshom Medical Chosen by the NIH to Attend the Angel Capital Association Annual Meeting

BALTIMORE, MD, US, May 10, 2024 – Linshom Medical, a Maryland based start-up medical device company was selected as one of eight companies to represent the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant portfolio at the Angel Capital Association (ACA) annual meeting in Columbus, OH on May 13-15, 2024.

After a competitive evaluation of 190 applications, Linshom Medical was chosen by the National Heart Lung & Blood Institute (NHLBI) as 1 of 8 companies to represent an NIH portfolio of over 1,000 companies.

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Welldoc Named “Best Overall Digital Health Company” for Second Consecutive Year in the 8th Annual MedTech Breakthrough Awards Program

COLUMBIA, Md., May 9, 2024 — Welldoc®, a leading digital health company specializing in cardiometabolic health, today announced that it has been selected as winner of the “Best Overall Digital Health Company” award for the second consecutive year in the 8th annual MedTech Breakthrough Awards. The awards program is conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market. This is the third year that MedTech Breakthrough has recognized Welldoc for its leadership and innovation in the digital health industry.  

The AI-powered Welldoc platform offers flexible, multi-condition digital coaching across diabetes, weight management with GLP-1 support, hypertension, heart failure, and prediabetes, with integrated mental wellbeing and sleep guidance. Through personalized, real-time and actionable insights, the platform empowers individuals to better self-manage their health and provides care teams with critical data to inform clinical decision-making. 

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Stem Cell Research Shines at Maryland Stem Cell and Regenerative Medicine Tech Showcase

COLUMBIA, MD (May 8, 2024) – Maryland’s leading edge in stem cell research was on full display at the Maryland Stem Cell and Regenerative Medicine Technology Showcase (“Showcase”) on April 25, 2024. This event, hosted as a collaborative effort between Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce, served as a platform to highlight groundbreaking advancements in stem cell and regenerative medicine from MSCRF portfolio members.

“This is an exciting time in the regenerative medicine space and the Maryland Stem Cell Research Fund is honored to support the innovations in stem cell therapy taking place in Maryland,” said MSCRF executive director, Ruchika Nijhara, PhD. “Maryland is home to pivotal and innovative stem cell research, and we are pleased to partner with the Department of Commerce to bring the regenerative medicine community together to share their cutting-edge research in this growing field.” 

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Kite and Arcellx Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.

The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.

Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration.

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Danaher Launches Collaboration with Johns Hopkins University Aiming to Improve Neurological Diagnosis

WASHINGTON, May 9, 2024 /PRNewswire/ — Danaher Corporation (NYSE: DHR), a global science and technology innovator (“Danaher”), today launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild TBI. As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Beckman Coulter Diagnostics, a Danaher subsidiary and leader in clinical diagnostics, to potentially establish correlations between a new biomarker panel and clinical outcomes.

Julie Sawyer Montgomery, Vice President and Group Executive, Danaher Diagnostics, said: “Our latest in vitro diagnostics innovations are improving the detection of specific biomarkers found in blood when brain cells are damaged. We are thrilled to partner with Johns Hopkins with the goal of leveraging these solutions to develop tests for earlier and more precise diagnosis of mild TBI, which could ultimately lead to improved treatment outcomes and faster recovery for patients.”

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Caring Cross and ImmunoAdoptive Cell Therapy (ImmunoACT) Announce Agreement to Commercialize TriCAR-T Cell Immunotherapy for Leukemia and Lymphoma

Agreement allows ImmunoACT to develop and commercialize a novel TriCAR-T cell therapy for leukemia and lymphoma designed to decrease lapses seen in current single CAR-T cell therapies and improve outcomes

GAITHERSBURG, Md. and MUMBAI, India, May 7, 2024 /PRNewswire/ — Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, and ImmunoAdoptive Cell Therapy (ImmunoACT), a Mumbai, India-based pioneering research and cell and gene therapy development company, announced an agreement to develop and commercialize a multi-targeted chimeric antigen receptor T-cell immunotherapy for leukemia and lymphoma. The TriCAR-T immunotherapy is designed to address relapse that can occur when patients with Leukemia or Lymphoma are treated with a single targeting anti-CD19 CAR T-cell product. Under the terms of the agreement, Caring Cross will provide a TriCAR-T cell immunotherapy for clinical development, manufacturing, and commercialization at ImmunoACT’s facilities in India.

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607th Edition, May 7, 2024

By BHI Weekly News Archives

Washington DC’s Nanochon closes $4M Series Seed Prime 

WASHINGTON–()–Nanochon, a Washington, DC-based orthopedic device biotech company has raised $4 million in its series seed prime fundraising round.

The round was led by The University of Virginia Licensing and Ventures Group Seed Fund, with participation from Cultivate (MD), Alumni Venture Group, and Mountain State Capital, among others.

Nanochon intends to use the funds to initiate its first in human clinical trials in the US in 2024, deepen research and development efforts, expand the company’s patent profile and grow its team.

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BISNOW: Maryland Life Sciences Seeks To Shift Away From ‘A World Of Office Parks’

May 2, 2024, Emily Wishingrad, Washington, D.C.
Maryland’s life sciences market, one of the largest in the country, has a lot of things going for it — a hearty talent pipeline, federal research agencies and relatively cheap real estate prices.

One thing that it doesn’t have pinned down quite yet: the urban, mixed-use, flexible developments that are most attractive to today’s tenants.
Local leaders and industry executives at Bisnow’s Mid-Atlantic Life Sciences and Biotech Summit last week said that for the area to keep up with its peer markets like Boston-Cambridge and San Diego, developers need to start thinking outside the traditional life sciences box.

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ARPA-H Sprinting toward solutions for women’s health

The ARPA-H Sprint for Women’s Health is a funding opportunity to address critical unmet challenges in women’s health, championing transformative innovations and tackling health conditions that uniquely or disproportionately affect women. ARPA-H is committing $100 million to this effort and is using two funding tracks, spark (early-stage research) and launchpad (later-stage development), to foster transformative research and development efforts. 

ARPA-H had an unprecedented response of submissions, representing 45 states, the District of Columbia, and 34 countries, received from a mix of scientific visionaries from across the globe and sectors. More than half of those submissions came from organizations with less than 50 people. Proposals covered the six topics, including the wild card, and innovative ideas ranged from novel, groundbreaking research to opportunities to accelerate and scale tools, products, and platforms with potential for commercialization. 

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Meet with… Johnson & Johnson’s Immunology Team on May 21st

Join us for Meet With…Johnson & Johnson’s Immunology Team at JLABS @ Washington, DC on May 21.

During Digestive Disease Week 2024, our Johnson & Johnson Immunology Team will present our strategic priorities in the space as part of our search for promising scientific innovations in the following areas: differentiated MOAs with potential for gut barrier restoration, patient stratification or use in combination regimes, and orals for clinically validated targets.

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Bethesda’s AsclepiX Therapeutics Completes Enrollment in DISCOVER Trial for Neovascular Age-Related Macular Degeneration (nAMD)

BETHESDA, Md., May 06, 2024 (GLOBE NEWSWIRE) — AsclepiX Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, today announced the completion of enrollment into the DISCOVER trial (NCT05859776). Fifteen patients have completed enrollment in the trial for AXT107 (gersizangitide). The objectives of the trial are to evaluate the safety and tolerability of three dose strengths of AXT107 [125 µg (n=3), 250 µg (n=3), and 500 µg (n=9)] and to determine the bioactivity and duration of action when injected suprachoroidally. Secondary endpoints will include efficacy as assessed by central subfield thickness (CST) and best-corrected visual acuity (BCVA). Following a single injection of AXT107, to date, no patient has shown any remarkable safety findings.

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BioSolution Designs & RoosterBio Announce Collaboration on Genetically Modified MSCs for Biotherapeutic Development

Frederick, MD, May 2, 2024 – BioSolution Designs (BSD), a biotechnology invention studio developing proprietary platforms for multigenic gene and cell therapies, today announced its ongoing strategic collaboration with RoosterBio, a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services.

This partnership leverages BSD’s multigenic design and assembly platform, Bird of Prey, and cell engineering expertise along with RoosterBio’s cutting-edge MSC and exosome bioprocessing products, manufacturing protocols, and analytical services to simplify the development and manufacturing of engineered MSC derived therapies.

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Publication Announcement: Welldoc Shares Clinical Research on AI and Weight Management

welldoc® recently presented a new clinical research paper at the 14th annual Conference on Health IT and Analytics (CHITA) in Washington, D.C. This research focuses on the latest advancements in artificial intelligence and weight management, areas of significant interest across the healthcare industry.

Hosted by the Center for Digital Health and Artificial Intelligence (CDHAI) at the Johns Hopkins Carey School of Business, CHITA explores innovative developments in the design, implementation, and management of health information technology and analytics.

Welldoc’s presentation, authored by Abhi Kumbara, Anand Iyer, and Mansur Shomali in collaboration with their colleagues from Johns Hopkins CDHAI, is now available on their website.

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NIH Entrepreneurship Bootcamp

The NIH Entrepreneurship Bootcamp is designed to equip life science investigators and nascent companies with specialized innovation and entrepreneurship training. The course requires no prior experience and uses a life science-focused customer discovery process to assess customer and stakeholder needs, and teaches participants to develop stronger business models, market strategies, and commercialization plans in advance of their initial SBIR/STTR application.

The Bootcamp places teams on a path to take advantage of other NIH innovation programs, particularly the I-Corps and SBIR programs. Critically, this course will improve the commercialization potential of a project no matter what direction teams ultimately pursue. The program is differentiated from I-Corps@NIH as it targets teams who have not yet been awarded an SBIR or STTR for their technical innovation and who may not yet have formed a company. More information is available through NOT-OD-24-103.

 

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606th Edition, April 30, 2024

By BHI Weekly News Archives

 

 

United Therapeutics Announces World’s First Successful Xenothymokidney Transplant 

The first living recipient of a UThymoKidney, in conjunction with a heart pump implant, is recovering after a successful transplant

This transplant builds on two successful UHeart transplants completed in 2022 and 2023

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the world’s first successful transplant of a UThymoKidney™, which the company produced, into a living person on April 12, 2024. This transplant represents several historic firsts for transplantation:
– The first-ever transplant of a xenothymokidney into a living human recipient;
– The first-ever combined mechanical heart pump and organ transplant; and
– The first-ever xenotransplant into a living human using only FDA-approved immunosuppressive medicines

The transplant is the third xenotransplant using United Therapeutics’ xeno organs, following two successful UHeart™ transplants at the University of Maryland Medicine in 2022 and 2023.

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Gain Therapeutics Announces Positive Results from the Single Ascending Dose (SAD) Part of the Phase 1 Clinical Trial of GT-02287, a Novel GCase-Targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

BETHESDA, Md., April 24, 2024 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces positive results from the single ascending dose (SAD) part of its Phase 1 study. GT-02287 was generally well tolerated up to and including the highest planned dose level, and there were no serious adverse events. The good safety and tolerability profile and the appropriate range of plasma exposure levels achieved after oral administration further bolster GT-02287’s best and first-in-class potential.

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Virginia Innovation Partnership Corporation (VIPC) Names Joe Benevento as President & CEO

Benevento to lead Virginia’s strategic authority that invests in startup companies, entrepreneurship ecosystems, university commercialization, innovation growth

VIPC is well-positioned to lead Virginia in developing, attracting, and retaining talent, capital, and innovation which expands investment, growth, and opportunity across the entire Commonwealth.”— Joe Benevento, VIPC President and CEO
RICHMOND, VIRGINIA, UNITED STATES, April 24, 2024 /EINPresswire.com/ — The Board of Directors of the Virginia Innovation Partnership Corporation (VIPC) has announced that it has unanimously selected Joe Benevento as President and CEO of VIPC.

Benevento has led VIPC as Interim President and CEO since September 2023 and previously served as Deputy Secretary of Commerce and Trade for the Commonwealth of Virginia since 2022. As Virginia’s Deputy Secretary of Commerce, Benevento helped develop Virginia’s “Compete to Win” and “Innovative Framework” strategy for driving economic growth across all regions of the Commonwealth and oversaw an industry portfolio which included Technology, Life Sciences, Aerospace & Defense, Semiconductors, Advanced Manufacturing, Cybersecurity, Unmanned Systems, and other key sectors.

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BISNOW: ‘Signs Of Rebound’ Emerging In Biotech, $11B In VC Funds To Kick-Start Recovery, Alexandria Says

April 18, 2024
For Global Investor Audience Only

April 23, 2024, Patrick Sisson, Bisnow National – One of the life sciences real estate’s biggest players sees a clear road to recovery, predicting that momentum, in the form of the increased investment dollars seen in early 2024, will hit its stride as the current glut of new supply tapers off in 2025.

During Alexandria Real Estate Equities’ first quarter earnings call, Chairman Joel Marcus cited “positive signs of rebound” in investment and financing for biotech, as well as strong performance from the REIT, which saw total revenues grow 9.7% to $769M.

Investments in the sector showed strength not seen since the high point of 2021. Nearly $11B in venture capital deployment in biotech was announced in Q1 2024, according to a sector overview from Alexandria Senior Vice President of Science and Technology Hallie Kuhn, who said increased investment was a “robust sign of the health of the industry.”

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MedCityNews: An Oveview of the Nation’s Largest SEED Fund

Eligible small businesses may receive millions of non-dilutive dollars from NIH’s Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs. Funding comes in tranches, from $300,000 – $4 million, based upon the stage of development and likelihood of the end product “moving the needle” in healthcare.

With over $1.3B dollars each year to fund U.S. startups, the National Institutes of Health (NIH) Small Business portfolio consists of life science companies dedicated to developing a full range of advanced technologies and products to improve the human condition.

Eligible small businesses may receive multiple millions of non-dilutive dollars from NIH’s Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs. Funding comes in tranches, from $300,000 – $4 million, based upon the stage of development and likelihood of the end product “moving the needle” in healthcare. Only the most innovative projects, with reasonable research plans, a strong team, and access to commercialization resources are funded. NIH-funded companies are often leading the curve in solving the most intractable healthcare challenges.

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AURP Wins Stage One of the U.S. Small Business Administration’s 2024 Growth Accelerator Fund Competition

AURP awarded $50,000 in prize money for equitable access to entrepreneurship

WASHINGTON, DC, and TUCSON, AZ / ACCESSWIRE / April 24, 2024 / The U.S. Small Business Administration (SBA) this week announced the Association of University Research Parks (AURP) as a Stage One winner for the 2024 Growth Accelerator Fund Competition (GAFC). AURP will receive a $50,000 cash prize for its impactful and inclusive approach to nurturing a collaborative national innovation ecosystem to advance small business research and development (R&D) from ideas to the market.

By fostering connections between entrepreneurs, mentors, partners, philanthropies, corporations, investors and other shared resources, GAFC 2024 catalyzes strategic ecosystem partnerships to build community and organizational capacity for the successful launch, growth and scale of STEM (Science, Technology, Engineering, and Mathematics)-based entrepreneurs.

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Pitchbook: The World’s Top Startup Cities

PitchBook’s VC Ecosystem Rankings compare global cities based on the size and maturity of their startup networks. The framework helps founders, operators and investors assess locations when deciding where to expand or invest.

Network effects matter in venture capital: Investors get more than half of their deals through referrals, according to research led by Harvard professor Paul Gompers. So it stands to reason that dealmakers should seek these networks out when deciding where to do business.

The list is based on a scoring system that uses PitchBook’s proprietary data on private companies. Development and growth scores are based on data related to deals, exits fundraising and other factors from the last six years.

For the best experience, view this dashboard on a desktop device. Read about our methodology below.

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Venable Ranks Among American Lawyer Magazine’s Top 100 Firms

Washington, DC (April 17, 2024) – Venable LLP is pleased to announce that it has been named to American Lawyer magazine’s 2024 Am Law 100 list. The annual ranking lists U.S. law firms based on 2023 gross revenue. Venable LLP moved up the list from last year to #64.

The firm also ranked strong in other categories, including:

  • #62 – Revenue per Lawyer
  • #67 – Profits by Lawyer
  • #78 – Compensation – All Partners
  • #80 – Profits per Equity Partner

 

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Deloitte Acquires Gryphon Scientific Business to Expand Security, Science and Public Health Capabilities

Acquisition will strengthen Deloitte team with a complement of data-driven biosecurity detection, prevention and emergency response solutions

ARLINGTON, Va., April 29, 2024  /PRNewswire/ — Deloitte announced that it has acquired substantially all of the assets of Gryphon Scientific, LLC (Gryphon), a leader in biosafety, biosecurity, and all-hazards preparedness and response, with experience in using artificial intelligence (AI) to enhance security and safety. Deloitte’s competitive edge will be strengthened by Gryphon’s multidisciplinary team who will be joining Deloitte, comprising scientists, programmers, and policy and planning professionals with experience in data science, scientific communications, modeling and risk assessment. Gryphon’s cadre of specialists will enhance Deloitte’s capability to address its clients’ most complex mission challenges, from informing safe policy and practice around novel technologies and AI to strengthening capacities to prevent, detect and respond to infectious disease threats across the globe.

 

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605th Edition, April 23, 2024

By BHI Weekly News Archives

 

 

Gaithersburg’s Salubris Biotherapeutics Announces $35 Million in Financing and Provides Pipeline Progress Update

Shenzhen Salubris commits additional funding to continue research and development of novel, complex biologics

First patient enrolled in RENEU-HF, the Phase 2 clinical trial of JK07 in heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF)

Clinical trial application filed for JK06, SalubrisBio’s first-in-class biparatopic ADC

April 22, 2024 07:00 AM Eastern Daylight Time
GAITHERSBURG, Md.–(BUSINESS WIRE)–Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs. SalubrisBio also provided progress updates for JK07, the first investigational antibody fusion protein for heart failure, JK08, the first investigational IL15-CTLA4 antibody fusion for solid tumors and JK06, a first-in-class biparatopic antibody-drug conjugate (ADC) targeting a known tumor antigen.

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Rockville’s DrFirst Acquires Myndshft Technologies to Revolutionize Medication Management by Addressing Both Pharmacy and Medical Benefits

Pioneering Move Unites Medical and Pharmacy Benefits, Enhancing Access, Affordability, and Adherence for Specialty Medications and Procedures

ROCKVILLE, Md., April 18, 2024 /PRNewswire/ — Healthcare technology pioneer DrFirst today announced it has acquired substantially all assets of Myndshft Technologies, Inc., a leader of end-to-end real-time medical benefits and automated prior authorization (PA) software-as-a-service (SaaS). This strategic acquisition aims to improve the patient experience and expedite access to vital specialty medications, such as infusions and in-office injectables primarily covered by medical benefits. Combined with DrFirst’s platform and scale, the technology will also lighten the substantial administrative load on healthcare providers and their staff.

Founded in 2018, Myndshft is the only unified platform that streamlines prior authorization and related services for both medical and pharmacy benefits. This innovative technology uses AI, machine learning, and robotic process automation (RPA) to automate and streamline complex benefits, pricing, and PA processes across various payers and therapeutic classes into one seamless, intuitive workflow. The Myndshft platform also supports labs, imaging, and other procedures covered under medical benefits, which are often prerequisites for patients prescribed specialty medications.

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USP joins BARDA’s BioMaP-Consortium

Rockville, MD, April 22, 2024 – U.S. Pharmacopeia (USP) is honored to announce its selection as a member of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), an organization that brings together biopharmaceutical industry partners across the manufacturing supply chain to support the Biomedical Advanced Research and Development Authority (BARDA).

The BioMaP-Consortium serves a critical role in ensuring that the United States can respond rapidly to public health emergencies by convening public and private industry partners to expand capacity and capabilities to produce medical countermeasures, products that help diagnose, prevent, or treat diseases related to chemical, biological, radiological, or nuclear threats.

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Novavax to Supply Updated COVID-19 Vaccine to Private Healthcare Providers in the United Kingdom

April 18, 2024
For Global Investor Audience Only

Novavax’s Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.

Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.

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Novel cell therapy treatments offer promise to immune-compromised children

Multi-institute clinical trial demonstrates therapy can be safely used in pediatric regional centers

WASHINGTON, April 18, 2024 (GLOBE NEWSWIRE) — In a first-of-its-kind clinical trial, researchers found that intravenous therapies made from virus-specific T-cells (VST) can effectively treat immunocompromised pediatric patients, far surpassing the current standard of care, according to new research published in Nature Communications.

More than 60% of patients in the phase 2 clinical trial led by investigators from Children’s National Hospital and Huntsman Cancer Institute responded to the innovative VST therapy. This new treatment uses blood from healthy donors to manufacture a highly specialized immune therapy that, when given to immune-compromised patients, prompts their immune system to fight off potentially life-threatening viruses, including cytomegalovirus, Epstein-Barr and adenovirus. Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.

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BioPharmaDive: Biotech landlord (and BHI Board Member) Joel Marcus on research clusters and the sector’s recovery

Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.

Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria Real Estate Equities has amassed tens of millions of square feet of office and laboratory space in drug development hubs like Boston, San Diego and the San Francisco Bay Area.

Those holdings have given Alexandria a front row seat to biotech’s boom over much of the past decade through to the sector’s pandemic highs and more recent downturn.

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TIME: We Need to be Ready for Biotech’s ChatGPT Moment

BY ERIC SCHMIDTAPRIL 16, 2024 4:20 PM EDT
Schmidt, Commissioner, National Security Commission on Emerging Biotechnology; Co-founder with his wife Wendy, Schmidt Sciences; Former CEO & Chairman, Google

Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could look like in the years ahead.

The next big game-changing revolution is in biology. It will allow us to more effectively fight disease, feed the planet, generate energy, and capture carbon. Already we’re on the cusp of these opportunities. Last year saw some important milestones: the U.S. approved the production and sale of lab-grown meat for the first time; Google DeepMind’s AI predicted structures of over 2 million new materials, which can potentially be used for chips and batteries; Casgevy became the first approved commercial gene-editing treatment using CRISPR. If I were a young person today, biology would truly be one of the most fascinating things to study.

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AMPEL BioSolutions Selected as Member of Prestigious Federal Health Innovation ARPA-H Network

CHARLOTTESVILLE, VA – April 22, 2024 – AMPEL BioSolutions has been selected as a member – or “spoke” – of the Customer Experience Hub of ARPANET-H, a prestigious nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).  This national effort is designed to accelerate commercialization of health breakthroughs for populations that urgently need them.  

The Customer Experience Hub in Dallas joins Boston and the Nation’s Capital as the three hubs across the country tasked with creating better health outcomes for all by accelerating commercialization of groundbreaking technologies that focus on health in two ways, by optimizing clinical trials for disease-altering therapies and implementing technologies that monitor & predict health outcomes.  This “prevent-detect-treat” effort connects biotechnology companies with funders, universities and non-profits in order to scale health breakthroughs.  

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604th Edition, April 16, 2024

By BHI Weekly News Archives
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April 16, 2024

TEDCO Invests in Astek Diagnostics

Maryland biotech company continuing mission to provide antibiotic sensitivity precision diagnostics

COLUMBIA, Md. (April 15, 2024) – fdfsTEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Seed Funds investment in Astek Diagnostics, a biomedical company.

“From the early days in my basement during the pandemic, TEDCO saw potential in our idea and supported us with our very first check,” said Mustafa Al-Adhami, CEO of Astek Diagnostics. “Today, our team stands strong at nine, having achieved the milestone of our first version of the product and partnerships with urology practices and hospitals across the globe.”

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WaPo: Former NIH director Collins on his prostate cancer, medical research

Over my 40 years as a physician-scientist, I’ve had the privilege of advising many patients facing serious medical diagnoses. I’ve seen them go through the excruciating experience of waiting for the results of a critical blood test, biopsy or scan that could dramatically affect their future hopes and dreams.

But this time, I was the one lying in the PET scanner as it searched for possible evidence of spread of my aggressive prostate cancer. I spent those 30 minutes in quiet prayer. If that cancer had already spread to my lymph nodes, bones, lungs or brain, it could still be treated — but it would no longer be curable.

Why am I going public about this cancer that many men are uncomfortable talking about? Because I want to lift the veil and share lifesaving information, and I want all men to benefit from the medical research to which I’ve devoted my career and that is now guiding my care.

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STAT: NCI director expresses optimism about next era of cancer research, despite shrinking budget and brain drain

SAN DIEGO — Kimryn Rathmell, director of the National Cancer Institute, gestured toward the screen and asked an audience of clinicians, researchers, and patient advocates what they thought they were looking at. Projected behind her was a patchwork of purple, red, pink, and blue squares.

Moments later, a larger-than-life image of Taylor Swift flashed in the middle of the pattern, and laughter rippled through the room here at the American Association for Cancer Research annual meeting as attendees realized they were staring at a poster of the singer’s “Eras Tour.”

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TEDCO Announces Federal Lab Leveraging Innovation to Products Pilot Program

Senators Cardin and Van Hollen requested more than $1 million to fund this new program

COLUMBIA, Md., (April 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, has received $1,150,000 in Congressionally Directed Spending to advance its Federal Lab Leveraging Innovation to Products (FLLIP) Pilot Program. The direct spending request was sponsored by U.S. Senators Ben Cardin and Chris Van Hollen (D-Md.) and included in the Fiscal Year 2024 Financial Services and General Government funding bill, which was signed into law last month as part of a FY24 appropriations package.

“Maryland is home to more than 70 federal labs, from the NIH in Silver Spring to the Frederick National Lab for Cancer Research and the Army Medical Research and Development Command,” said Senator Cardin. “With this federal investment, we’re making it easier for traditionally underserved businesses in the healthcare industry to take full advantage of the resources right in their backyard. Community partnerships like the FLLIP Program drive innovation in the state and help build a more equitable, prepared and developed health care system.”

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Pitchbook: 3 charts: The US has more startups than VCs can support

2024 may well become the year of the bootstrapped founder.

The startup “mass extinction event” that doomsayers have predicted for two years is likely to ramp up in 2024. New founders facing a brutal funding environment may instead opt to bootstrap their growth.

Over 55,000 VC-backed companies are operating in the US right now, according to the latest PitchBook-NVCA Venture Monitor. Many of them are aggressively competing for funding in a slow dealmaking landscape.

At the same time, over 2,000 VC firms effectively halted making new investments in startups in the first nine months of 2023. Approximately 3,200 startups failed in 2023, and there’s even a burgeoning industry dedicated to helping founders wind down their companies.

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FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

(4/15/2024) Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”

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603rd Edition, April 09, 2024

By BHI Weekly News Archives

 

 

 

TEDCO Invests in Aloe Therapeutics

COLUMBIA, Md. (April 8, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Aloe Therapeutics, a company working to deliver cancer cures. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Aloe Therapeutics, we are working to increase efficacy and expand eligibility for patients with hard-to-treat solid tumors and limited treatment options,” said Martha Sklavos, founder and CEO of Aloe Therapeutics. “Thanks to TEDCO’s investment we can continue to develop our lead therapy to the clinic to ‘wake up the immune system’ with our cell-based therapeutic vaccine, Allo-Immunotherapy (AIM).

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CF Foundation Provides Up to $8.5M to SpliSense to Support a Clinical Trial for a Potential Treatment for Splicing Mutations

BETHESDA, Md.–()–The Cystic Fibrosis Foundation is investing up to $8.5 million in additional funds in SpliSense to continue clinical trials for its inhaled antisense oligonucleotide (ASO) drug for people with cystic fibrosis who have certain splicing mutations and potentially other rare mutations.

The Foundation’s funding will support a planned Phase 2 clinical trial to test the efficacy of SpliSense’s inhaled ASO drug as a potential treatment for the lungs of people with the splicing mutation 3849+10Kb C-to-T. A recent Phase 1a study indicated the drug was safe and well tolerated.

“We continue to pursue diverse strategies to develop potential treatments for people with CF who can’t benefit from existing modulator therapies,” said Steven M. Rowe, MD, executive vice president and chief scientific officer at the Foundation. “Information from this study is key to advancing those efforts with a novel technology and will also provide valuable insight into the development of therapies for people with rare mutations.”

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Washington D.C.’s 60 Degrees Pharmaceuticals to Sponsor Pilot Study of Tafenoquine for Treatment of Canine Babesiosis

WASHINGTON, April 03, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the Company will sponsor a pilot study of tafenoquine, the active molecule in its U.S. Food and Drug Administration (FDA)-approved human malaria prevention medication, ARAKODA®, for the treatment of babesiosis in dogs. The study will support a broader effort now being led by 60 Degrees Pharmaceuticals to evaluate tafenoquine for various babesiosis indications.

Tafenoquine has not been proven to be effective for treatment or prevention of canine babesiosis and is not approved by the FDA for such an indication.

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MaxCyte Signs Strategic Platform License with Be Biopharma to Support the Development of Engineered B Cell Medicines (BCMs)

Be Biopharma to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform within its Engineered B Cell Medicines programs

ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications and Be Biopharma (“Be Bio”), a company pioneering the development of Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with genetic diseases, cancer, and other serious conditions, today announced the signing of a strategic platform license (SPL) to support the development of Be Bio’s BCMs programs.

Under the terms of the agreement, Be Bio obtains non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.

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Medcura Closes $22.4 Million Financing to Accelerate Development of Surgical Hemostatic Gel and Surgical Hemostasis Portfolio

RIVERDALE, Md., April 3, 2024 /PRNewswire/ — Medcura, Inc., a developer of hemostatic products for use in surgery, today announced that it has closed a private placement with aggregate gross proceeds of US $22.4 million (the “Offering”) in Convertible Debt. The Company intends to use the proceeds from this Offering to accelerate the development of its lead surgical product, LifeGel™ Absorbable Hemostatic Gel.  Medcura will complete its pre-clinical testing and file an Investigational Device Exemption for LifeGel with the U.S. FDA to support a global investigational study focused on stopping bleeding in spinal surgery. Current hemostatic agents swell and can cause neurological issues, including paralysis, when used in confined spaces routinely addressed in spinal surgery.

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602nd Edition, April 2, 2024

By BHI Weekly News Archives

 

 

 

Surviving and Thriving: John Sackett, Executive Vice President & COO of Adventist Healthcare, and a 67-Year-Old Cystic Fibrosis (CF) Survivor, Offers Perspectives on CF Life Science Innovation with Rich Bendis on BioTalk

ROCKVILLE, MARYLAND, April 1, 2024 – BioHealth Innovation, Inc. (BHI) is delighted to present a compelling episode on its podcast, BioTalk with Rich Bendis, titled “Transforming Healthcare: Insights from John Sackett, Adventist Healthcare COO on BioTalk.” In this captivating episode, John Sackett, Executive Vice President & COO of Adventist Healthcare, shares his extraordinary journey and invaluable insights into the evolving landscape of healthcare delivery, all while managing cystic fibrosis.

John Sackett’s story is one of resilience, leadership, and innovation. From his early days as an administrative assistant to his current role as Executive Vice President & COO of Adventist Healthcare, John has demonstrated unwavering dedication to improving healthcare outcomes in the BioHealth Capital Region (BHCR). Despite the challenges posed by cystic fibrosis, a chronic and life-threatening genetic disease, John has thrived professionally and emerged as an inspirational figure, defying the odds and becoming a beacon of hope for others.

In this episode, John candidly discusses his personal journey of managing cystic fibrosis while excelling in his career. His story sheds light on the challenges faced by individuals living with chronic illnesses and underscores the importance of resilience, innovation, and patient-centered care in healthcare delivery.

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Baltimore’s LaunchPort Welcomes New Resident JuneBrain

LaunchPort welcomes CEO Samantha Scott and her team as the latest Residents to join the Baltimore Peninsula site.

JuneBrain Inc. (https://www.junebrain.com/) offers accessible monitoring solutions for eye care and neurology. With approximately 1.3 billion individuals worldwide afflicted by conditions such as multiple sclerosis (MS) and age-related macular degeneration (AMD), tracking the progression of these ailments often involves monitoring the retina. To address this need, JuneBrain has developed an AI-driven wearable eye-scanning device and SaaS platform. This innovation facilitates the detection of new disease activity and empowers clinicians to monitor disease progression and patient responses to treatment between clinical visits.

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TEDCO Invests in Baltimore Medical Device Company LASARRUS

COLUMBIA, Md. (April 1, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $50,000 Pre-Seed Builder Fund investment in LASARRUS, a medical device company dedicating to supporting Chronic Obstructive Pulmonary Disease (COPD) patients. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“With our innovative device, we are looking to bring current monitoring practices for COPD patients to a new level,” said Lloyd Emokpae, co-founder, CEO and chief technology officer of LASARRUS. “Thanks to TEDCO’s investment we can accelerate our mission to enhance care for COPD patients and ultimately support more COPD patients across Maryland and beyond.”

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CNBC – Altimmune says weight loss drug minimized muscle loss in trial results, which may set it apart

Altimmune on Wednesday said its experimental drug helped patients shed weight but also minimized the loss of muscle mass in a midstage trial, a finding that could set it apart in a potentially crowded market.

Altimmune is one of several smaller biotech companies that are pushing to compete directly with Novo Nordisk and Eli Lilly in the growing weight loss drug space, or to get scooped up by larger drugmakers that can help bring their treatments to market.

The results are an early sign that the biotech company can address a major concern around those treatments, which have drawn unrelenting demand and investor interest over the last year.

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NIH cancer physician-scientist Christopher Hourigan joins Virginia Tech to lead research in Washington, D.C.

A globally recognized physician-scientist who studies and treats blood cancer is joining Virginia Tech to lead cancer research in Washington, D.C., said Michael Friedlander, Virginia Tech’s vice president for health sciences and technology and executive director of the Fralin Biomedical Research Institute at VTC.

Christopher Hourigan, a senior investigator and chief of the Laboratory of Myeloid Malignancies at the National Institutes of Health, will join Virginia Tech as a professor with the institute and director of its Cancer Research Center in Washington, D.C.

“Dr. Hourigan exemplifies the prototype of a physician-scientist, integrating insights from his patient interactions directly into his fundamental and translational laboratory research,” Friedlander said. “We are extremely enthusiastic to have him join Virginia Tech and become a member of the Fralin Biomedical Research Institute team to take on this important new leadership role for our growing cancer research programs in Washington, D.C., and to further strengthen our collaborations with Carilion Clinic, Children’s National Hospital, and other health systems and universities.

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Maryland Life Science Trend Analysis 2024

Venture financing for Maryland’s life sciences industry in 2023 shows signs of recovery following the significant downturn in 2022, with the total value of private equity financing reaching USD 805m (up from USD 639m in 2022). For the biotech industry, the value of venture financing deals remained stable (USD 453m in 2022 vs. USD 451m in 2023), while the number of funding rounds increased by nearly half (26 rounds in 2022 vs. 38 rounds in 2023).

Among Maryland-based companies that went public in 2023, YS Biopharma led the way with a SPAC merger raising gross proceeds of USD 36m, followed by the IPOs of MIRA Pharmaceuticals (USD 8.9m) and Bullfrog AI Holdings (USD 8.4m). The two largest private equity financing rounds for biotech companies were raised by Georgiamune Inc. with a Series A round of USD 75m and ManaT Bio with a financing round of USD 72m.

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BioBuzz Networks and the International Society of Pharmaceutical Engineering – Chesapeake Bay Area Chapter Announce Exciting Partnership

March 28, 2024, Baltimore, MD. – BioBuzz Networks and the International Society of Pharmaceutical Engineering (ISPE) – Chesapeake Bay Area (CBA) Chapter are pleased to announce the establishment of a Memorandum of Understanding (MOU) between the two organizations. This MOU will enable both BioBuzz and ISPE-CBA to formally work together to help strengthen Maryland’s pharmaceutical and biotech industries by building a stronger, more connected community.

Both Biobuzz and ISPE-CBA provide important educational and networking opportunities for the large biopharma community that has grown in Maryland. In fact, the BioHealth Capital Region (Maryland / Virginia / Washington, D.C) is the third largest biopharma cluster in the United States. Working as ISPE-CBA’s official media partner, the partnership will enable BioBuzz to participate in each of ISPE-CBA’s many events, which include sustainability and other educational webinars and site tours, Women in Pharma®, Emerging Leader, and Student educational and networking initiatives, and numerous social events, as well as the Chapter’s annual conference, the Mid-Atlantic Science & Technology (MAST) Meeting, which provides a full day of education, networking opportunities, and an exhibit hall for pharma/biotech companies and service providers alike to share their products, introduce their company, and raise their brand’s industry profile.  ISPE-CBA, based on this partnership, will enjoy continuous promotion on BioBuzz’ substantial online media network, with a reach of more than 400,000 viewers, and will enjoy an enhanced presence at BioBuzz’ many networking events held throughout Maryland each year.

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Kory Bailey and Rich Tall

601st Edition, March 26, 2024

By BHI Weekly News Archives

 

 

 

 

Building Baltimore’s Future: Kory Bailey and the UpSurge Vision on BioTalk

Join us in this episode of BioTalk with Rich Bendis as we delve into the Baltimore ecosystem with Kory Bailey, Chief Ecosystem Officer (CEO) of UpSurge Baltimore, a trailblazing organization dedicated to fostering equitable economic growth and innovation.

Kory Bailey brings over a decade of leadership experience from both early-stage startups and big tech. He has emerged as a thought leader on equitable economic growth and a champion for Baltimore’s tech ecosystem. As the CEO of UpSurge Baltimore, Kory is spearheading the vision for Baltimore to become the first Equitech hub globally, pioneering a new model for American innovation.

Listen now via your favorite podcast platform:

Apple: https://apple.co/4a6C9GQ
Google: https://bit.ly/3IOlFae
Spotify: https://spoti.fi/3vtbl4v
Amazon Music: https://amzn.to/3vpZDHI
TuneIn: https://bit.ly/3VvuWvk

In this discussion, Kory unveils UpSurge Baltimore’s mission: to cultivate a thriving tech ecosystem for innovators, founders, and talent by fostering culture and connectivity and mobilizing regional and national assets around Baltimore startups.

From exploring what drew him to Baltimore to discussing the evolution and unique aspects of UpSurge, Kory shares insights into the philanthropic landscape in Baltimore and initiatives like the Equitech Accelerator, Techstars, KHU, and CareFirst. He also delves into the primary challenges facing Baltimore and UpSurge’s short-term goals focused on accountability, awareness, investment, and early-stage support.

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TEDCO Invests in Innate Technologies, Inc.

COLUMBIA, Md. (March 20, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Maryland Equity Investment Fund (MEIF) investment in Innate Technologies, Inc. The MEIF – which is housed under TEDCO’s Venture Funds – was created to increase private equity and venture capital in Maryland, generate financial returns, and foster economic growth.

“Our goal at Innate Technologies is to provide a solution that will fill the current void in digital manufacturing practices – data integration,” said Shawn Springs, founder and CEO of Innate Technologies, Inc. “Thanks to TEDCO’s investment we can continue our mission to revolutionize manufacturing through data collaboration.”

Innate Technologies, Inc., headquartered in North Bethesda, Md., has a mission to deliver innovative software solutions for the digital manufacturing sector. Combining cutting-edge technology with industry expertise, they look to empower businesses by bridging the gap between sales and production teams, fostering smarter manufacturing practices.

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AMPEL BioSolutions’ Lupus Test Launches to Predict Flares & Drug Targets

CHARLOTTESVILLE, VA – March 26, 2024 – AMPEL BioSolutions announces a breakthrough in personalized precision medicine that will revolutionize the way doctors manage the autoimmune disease Lupus.  Revealed in the peer-reviewed journal Genome Medicine and being made available to patients through a US follow-on study, the LuGENE® blood test forecasts patient flares and drug targets from gene expression utilizing predictive AI.

The LuGENE® lab test is now launching at several Lupus practices around the country including those in medical centers, concierge practices and healthcare systems as a practical decision support biomarker test that could greatly impact day-to-day healthcare for patients with Lupus.  The blood test predicts flares before they happen and provides specific information about a patient’s disease abnormalities leading to symptoms, allowing physicians to make evidence-based decisions regarding therapy including whether a patient is stable on their current therapeutic regimen.  There are a million and a half lupus patients in the US that could benefit from LuGENE® by preventing unexpected flares and shortening the time to disease-controlling therapy.

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Built in Baltimore: CoapTech, Inc. Announces Market Launch of its Second Generation Magnetic Balloon Catheter for the PUMA-G System

BALTIMORE, MD, March 19, 2024 –, CoapTech, Inc., a medical device company delivering transformative solutions for minimally-invasive surgery, announced today the market launch and historic first bedside use case of its second generation magnetic balloon catheter. The magnetic balloon catheter is a key component of the PUMA-G System™ which enables ultrasound placement of gastrostomy tubes (i.e. permanent feeding tubes), necessary to nourish patients to recovery. The PUMA-G System is manufactured in Baltimore in collaboration with The LaunchPort™.

This first bedside use case was completed in the critical care unit (better known as ICU) at the University of Maryland Baltimore Washington Medical Center (UM BWMC) and was performed by Darwin Ashbaker, MD, and Stephen Griffin, PA, on February 27, 2024.

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WBJ: Germantown Precigen Inc. biotech expands manufacturing capacity, headcount ahead of potential product launch

Germantown’s Precigen Inc., a clinical-stage biotech developing gene and cell therapies for cancers and other diseases, is taking steps to get an experimental treatment to regulators for review this year — which could pave the path for a market launch in 2025.

The 26-year-old Precigen (NASDAQ: PGEN) has been advancing an immunotherapy to treat a rare disease most common in kids called recurrent respiratory papillomatosis, or RRP. It’s on track to wrap up a phase 2 clinical trial in the second quarter that, if successful, could set it up for the Food and Drug Administration’s signoff to get it to patients next year.

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Biofactura, Inc. Expands presence at Riverside Tech Park in Frederick, Maryland to 17,520 Square Feet

Biotechnology company consolidates operations in business community and expects to employ over 50 engineers, scientists, quality-control professionals, and related positions

FREDERICK, Md., March 20, 2024 /PRNewswire-PRWeb/ — BioFactura, Inc. has signed a lease with St. John Properties, Inc. for 12,000 square feet of space at Riverside Tech Park, a 70-acre business community located in Frederick, Maryland. The biotechnology firm has occupied 5,520 square feet of space at 8435 Progress Drive in Riverside Technology Park since 2015 and this new requirement expands the company’s presence to 17,520 square feet of space within the building. Danny Foit, Leasing Representative for St. John Properties represented the landlord.

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CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology

CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may.

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today announced the peer reviewed scientific journal Frontiers in Immunology published an article regarding CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology in the treatment of rheumatoid arthritis (RA) titled: “Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines”. CEL-SCI’s LEAPS team, along with outside collaborators from U.S. and Europe, reviewed published/presented results from pre-clinical animal model of antigen-specific LEAPS therapeutic vaccines, such as CEL-4000 and CEL-5000, made specific for the treatment of RA, and compared these findings with published results of other RA-therapies that either suppress or alter the immune response in order to treat RA.
In the article, the authors note that the currently available therapeutic arsenal for the treatment of RA consists mainly of immunosuppressive or ablative drugs, which may carry the potential risk of facilitating recurrent or primary infectious diseases or cancer.

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Clasp Therapeutics Launches With $150 Million to Pioneer Precision Immuno-Oncology Using Next-Generation T Cell Engagers With Unparalleled Specificity

CAMBRIDGE, Mass. & ROCKVILLE, Md.–()–Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T cell engagers (TCEs), launched today with $150 million in financing.

The round was led by Catalio Capital Management, Third Rock Ventures and Novo Holdings, with participation from Vivo Capital, Cure Ventures, Blackbird BioVentures, Pictet Alternative Advisors, American Cancer Society’s Bright Edge and Alexandria Venture Investments. Clasp is developing modular TCEs tailored to each patient’s immune system that are directed to common oncogenic driver mutations, resulting in off-the-shelf, antibody-like medicines that can specifically target a wide variety of hard-to-treat tumor types.

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