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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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John Sackett and Rich 250 x 600 px

600th Edition, March 19, 2024

By BHI Weekly News Archives

 

Transforming Healthcare: Insights from John Sackett, Adventist Healthcare COO on BioTalk

Discover the Future of Healthcare with John Sackett, Executive Vice President & COO of Adventist Healthcare, on BioTalk with Rich Bendis.

In this episode, John Sackett shares his insights into the changing landscape of healthcare delivery. From his early days as an administrative assistant to his current role, John’s journey offers invaluable lessons on leadership and innovation in the healthcare industry.

Join us as we explore Adventist Healthcare’s role in the BioHealth Capital Region (BHCR) and explore the transformative changes in healthcare delivery. Gain valuable insights into the challenges and innovations reshaping healthcare post-COVID and learn how Adventist Healthcare is leading the way in patient-centered care.

Listen now via your favorite podcast platform:

Apple – https://apple.co/3PrPeCp
Google – https://bit.ly/3TGMaos
Spotify – https://spoti.fi/49YKgFf
Amazon Music – https://amzn.to/3Vt96sF
TuneIn – https://bit.ly/3Voub7o

In a candid and inspiring segment, John opens up about his personal journey of managing cystic fibrosis while excelling in his career. Discover the remarkable advancements in the treatment and life expectancy of CF patients, highlighting the power of innovation and resilience in overcoming adversity.

Don’t miss this enlightening episode as we navigate the evolving landscape of BioHealth Innovation and the BHCR Region with John Sackett, a visionary leader shaping the future of healthcare.

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Bill Enright, CEO at Barinthus Biotherapeutics, reveals the philosophy that built his biotech business

Navigating the uncertain road of entrepreneurship

This year marks the year of the dragon in Chinese culture. The dragon symbolises nobility, good fortune, and vitality and presents a year of auspicious opportunities. Against the backdrop of 2023, I’d say this is a fortune well worth getting behind.

The past year has been difficult for most companies, but for business leaders it has meant summoning inner strength and resilience. If you’re an entrepreneur, give yourself a pat on the back. You’ve taken an ambitious and courageous leap to launch and build a company during what has been a challenging economic climate for life sciences and biotech startups. The post-pandemic financial downturn saddled us with the impacts of inflation, volatile supply chains, and a stagnant venture funding environment. Research and developing innovation are a risky business even in the best financial conditions, so give yourself credit for tackling this important work during a time of uncertainty.

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Rockville’s Expert Systems Celebrates a Milestone with Eilean Therapeutics: Initiation of First-in-Patient Trial of Balamenib, a Selective Best-in-Class Menin Inhibitor

ROCKVILLE, Md., March 13, 2024 /PRNewswire/ — Expert Systems, a leader in AI-enabled drug discovery, proudly announces a significant milestone in partnership with Eilean Therapeutics LLC: the start of Phase 1 trial of balamenib (ZE63-0302), a highly selective inhibitor of the menin–KMT2A binding interaction, under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutics Goods Administration (TGA).

“Balamenib has a highly differentiated pre-clinical profile which indicates important advantages over molecules in the same class in safety, tolerability and feasibility of outpatient treatment,” commented Bill Farley, CBO at Expert Systems. “We are proud that our comprehensive hybrid AI-based platform has helped accelerate the development of a new promising & safe treatment for AML.”

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Northern Virginia’s Zephyr AI Raises $111 Million in Series A Financing

MCLEAN, Va.–(BUSINESS WIRE)–Zephyr AI, Inc. (“Zephyr AI”), a healthcare technology company committed to developing fast and explainable Artificial Intelligence (AI) solutions to democratize precision medicine, today announced it has successfully closed a $111 million Series A funding round with participation from Revolution Growth, Eli Lilly & Company, Jeff Skoll, and EPIQ Capital Group, among others. The company is developing improved data federation tools along with various machine learning algorithms in the areas of oncology and cardiometabolic disease.

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BioBuzz: JLABS Brings Companies and Investors Together for Third Annual Partnering Day Event

Dozens of life sciences startups and early-stage company companies are honing their pitch decks and looking to head to New York, the center of the financial world, for a one-day investor and partnering event in hopes of securing financial partnerships.

In May, Johnson & Johnson – JLABS will hold its third annual Investor & Partnering Day in New York City at the New York Genome Center, a non-profit hub for collaborative genomic research and the home of JLABS @ NYC. The partnering day offers participating companies multiple meetings with investor organizations to highlight their science & technology, expand their investor network, and potentially securing funding to support ongoing and future operations.

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WBJ: Rockville biotech raises $140M following layoffs, program cuts

By Sara Gilgore – Staff Reporter, Washington Business Journal – Rockville’s RegenxBio Inc. (NASDAQ: RGNX) has raised $140 million in a public offering, four months after making significant cuts to extend its cash runway.

The clinical-stage biotech, which is developing gene therapies for retinal and neurodegenerative diseases, closed the previously announced offering Monday, a company spokesperson confirmed to the Washington Business Journal.

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BHI Womens Day2

599th Edition, March 12, 2024

By BHI Weekly News Archives

 

BHI Celebrates Women Life Science Leaders serving the BioHealth Industry

On International Women’s Day, we celebrate and recognize the remarkable women of BHI for their invaluable contributions to advancing healthcare innovation and shaping the future of biohealth.

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ARPA-H Takes on Rare Diseases

There are more than 10,000 known rare diseases and only a few hundred have safe, effective treatments. ARPA-H’s latest project aims to change that and deliver hope and improved outcomes to millions of Americans.

Introducing MATRIX. Short for ML/AI-Aided Therapeutic Repurposing in eXtended uses, MATRIX intends to build a machine learning platform to rapidly pinpoint and validate existing medications to treat diseases that have no therapies.

• The platform will be open-sourced and include an interactive heatmap displaying predicted efficacy scores for approved drugs against other diseases.

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TEDCO Invests in Sonogen Medical

Life science company working to develop ultrasonic bone fracture healing technology

 COLUMBIA, Md. (March 11, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment in Sonogen Medical, a medical device company based in Maryland.

“Roughly eight percent of the seven million bone breaks annually in the United States fail to heal on their own. At Sonogen Medical, we are combining decades of experience to create a device that supports faster more efficient healing processes for patients,” said Jason Winder, CEO of Sonogen Medical. “Thanks to TEDCO’s investment we can continue our research and development efforts, propelling us towards an efficient, cost-effective solution.”

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Women’s Health Innovation Summit USA – Hear from ARPA-H, White House Initiative on Women’s Health Research and WHAM

Hear from ARPA-H Director Renee Wegrzyn, PhD and White House Initiative on Women’s Health Research Director Carolyn Mazure, PhD on the new $100M ARPA-H Sprint for Women’s Health Program and the White House plans, plus insights from WHAM Founder Carolee Lee and AMWA President Elizabeth Garner, MD. If you are an innovator, founder, funder, researcher or care about driving meaningful change in advancing the health of women, this event is for you!

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BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Acquisition will create phage therapy company with an advanced pipeline with two Phase 2 assets, BX004 for the treatment of chronic pulmonary infections in cystic fibrosis (“CF”) patients and BX211 for the treatment of diabetic foot osteomyelitis (“DFO”)

Concurrently with entering into the definitive merger agreement, BiomX entered into a definitive agreement for a private placement financing of $50 million that will be used to advance two lead product candidates through Phase 2 clinical readouts in 2025

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VCU’s new Startup Accelerator will propel university research that has market potential

Program to ‘fast-track’ emerging companies reflects how innovation and entrepreneurship are growing as VCU sets funding records.

After years of supporting startups that license inventions created by university researchers, Virginia Commonwealth University’s Office of the Vice President for Research and Innovation has launched its first formal Startup Accelerator program.

“Our accelerator will fast-track our VCU-borne companies, giving them more personalized coaching and advisory services from our lineup of entrepreneur experts-in-residence,” said P. Srirama Rao, Ph.D., vice president for research and innovation. “Innovation is taking place at a rapid pace at VCU, and this program will further raise our national visibility and continue to position Central Virginia as a key American technological hub.”

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Council on Strategic Risks: The National Security Rationale for Stockpiling Key Pharmaceutical Ingredients

By Vic Suarez – The COVID-19 global pandemic has underscored the critical need for resilient and secure supply chains, particularly in the pharmaceutical industry. As the United States grapples with near-all-time high drug shortages1 and the vulnerability of its supply chain, it has become a national security imperative to address the overreliance on imports for active pharmaceutical ingredients (API) to the United States. Today, China is the sole source for about 20% of the API of our most vital medicines.2 More dangerously, China’s overwhelming global dominance of the key starting materials (KSM) required to produce these essential medicines cannot be readily substituted due to the current levels of market concentration: approximately 45% of KSM, a vital subcategory of API, are solely sourced from China, according to the API Innovation Center.3 To be sure, this level of import dependence on any single nation poses a serious risk to the nation’s general preparedness and resilience, and could become devastating in a crisis.

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1709221846602

598th Edition, March 5, 2024

By BHI Weekly News Archives

 

TEDCO Announces SSBCI Investment in Linshom Medical

Maryland company continues toward goal of supporting improved patient safety

COLUMBIA, Md. (February 29, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $400,000 investment into Linshom Medical, Inc., a medical device company developing an innovative wearable sensor technology to support patient respiratory monitoring. This recent investment came in two parts – $250,000 from the State Small Business Credit Initiative (SSBCI) funding and $150,000 from the Venture Funds – and was done in conjunction with Abell Foundation.

TEDCO’s SSBCI funds were provided after the State of Maryland chose TEDCO to be one of the various stewards of this essential funding, allowing for more investments in target communities and areas with small, micro and Socially and Economically Disadvantaged Individual (SEDI) businesses. Click here to learn more.

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Gain Therapeutics Announces the Initiation of the Multiple Ascending Dose (MAD) Part of the Phase 1 Clinical Trial of GT-02287, a Novel GCase-targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

BETHESDA, Md., Feb. 27, 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 the initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease.

Based on the safety and tolerability profile observed in the Single Ascending Dose (SAD) cohorts of the study, the Bellberry Human Research Ethics Committee (HREC) in Australia approved the start of the MAD part of the study in parallel with the completion of the last SAD cohorts. Following the HREC approval, administration of GT-02287 in the MAD part of the study has been initiated.

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ATCC and Tissue Dynamics Announce a Strategic Collaboration to Bring a Transformative Heart Organoid Model to Market

MANASSAS, Va. & TEL AVIV, Israel–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, and Tissue Dynamics, a disruptive pharma-tech company integrating advanced artificial intelligence tools with bionic human organoids, today announced a partnership to develop workflow friendly cardiac organoids-based kits for improved cardiac safety testing in drug development. The collaboration will be done under the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) framework, which awarded both companies a two-year grant. The BIRD Foundation, established in 1977, bolsters transformative partnerships that stimulate, promote, and support industrial research and development in a wide range of technology sectors.

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BioBuzz’s 10 Women in the Life Sciences That You Should Know in the BioHealth Capital Region

In honor of Women’s History Month, which kicks off today, we wanted to highlight 10 incredible women making a mark in the life sciences in the BioHealth Capital Region. This is just the tip of the iceberg.

Arti Santhanam, Executive Director, Emerging Technology Centers (ETC)
Dr. Arti Santhanam was recently appointed Executive Director of Emerging Technology Centers (ETC). While new to the role, Dr. Santhanam is a long-time player in the BioHealth Capital Region.

Dr. Santhanam’s contributions over the last decade at TEDCO, especially within her role in the Maryland Innovation Initiative (MII), have been instrumental in fostering Maryland’s diverse and innovative ecosystem. Established in 2012, MII has invested $52.3M, resulting in 176 startups from notable universities like Johns Hopkins, the University of Maryland, and Morgan.

In her new role, she’ll be introducing a new public-private operational model enhancing support for Baltimore’s tech entrepreneurs, activating her extensive expertise in startup leadership, venture capital, and life sciences.

Prior to TEDCO, Dr. Santhanam worked in global health at MITRE Corporation and in private consulting, collaborating with USAMRIID and ECBC. Dr. Santhanam earned her Master’s in Clinical Biochemistry from the University of Madras, India, and a PhD in Microbiology from Rutgers University, NJ, followed by a postdoc at the National Cancer Institute. She’s held roles on METAvivor Research and Support, Inc.’s Board and various Maryland advisory boards, demonstrating her leadership in health and innovation.

Chandra Briggman, CEO, Activation Capital
Chandra Briggman is President and CEO of Activation Capital, a leading innovation ecosystem development organization providing social, knowledge, and financial capital to tech clusters across the Commonwealth of Virginia.

Before being named the CEO in May 2020, Briggman was Director of Venture Café Foundation located in Cambridge, MA, and was responsible for the strategy and operations of the global network’s flagship Venture Café Cambridge innovation hub. She played a key role in helping expand the revenue and the footprint in New England. Before her work in ecosystem development in Massachusetts, she held innovation roles with the United States Postal Service in Washington, D.C., culminating with her work as the Director of Digital Platforms and the Innovation Lab. Her prior experience comprised leadership roles with multiple startups, including Founder as a serial entrepreneur.

Click here to keep reading via BioBuzz.

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Rockville Economic Development, Inc. (REDI) Announces BioBoost Series (March 20, 2024)

Rockville Economic Development, Inc. (REDI) is set to launch its first BioBoost series on March 20, 2024, in Rockville, MD. This pioneering event, titled “The Future of Bio/Life Science Funding in 2024,” promises to be a cornerstone for professionals in the bio/life science sector. Attendees will have the unique opportunity to delve into the latest investment trends, overcome industry challenges, and discover new funding opportunities through insightful discussions led by esteemed industry experts.

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Three Congressional Letters Show the March-In Debate Has Shifted

When the Biden Administration unleashed its proposed march-in guidelines last December, it claimed they would be a powerful tool for lowering drug prices by allowing the government to “march in” to license copiers under the authorities of the Bayh-Dole Act.

It did so despite previously joining every other Administration denying price control petitions as not authorized under the law. It should have known the proposal would have minimal impact on drug prices—but would have a devastating impact on American innovation. That’s because the guidelines apply to all federal R&D agencies—not just the National Institutes of Health — so they cover inventions across the spectrum, not just the life sciences.

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Cartesian Therapeutics Establishes New Corporate Headquarters and State-of-the-Art mRNA Cell Therapy cGMP Manufacturing Facility in Frederick, Maryland

New facility expected to support expanded cGMP manufacturing of clinical and commercial supply of Company’s pipeline of mRNA cell therapies for the treatment of autoimmune diseases

GAITHERSBURG, Md., March 05, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced its plans to transition its corporate headquarters to Frederick, Maryland. The approximately 20,000 square foot state-of-the-art current good manufacturing practice (cGMP) compliant facility has clinical and commercial manufacturing scale capabilities designed to support the Company’s maturing pipeline of innovative mRNA cell therapies for the treatment of autoimmune diseases.

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