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568th Edition, August 1, 2023

By BHI Weekly News Archives

 

 

 

 

miRecule and Sanofi drive the emergence of RNA therapeutics for Rare Diseases
 

After the race to find a COVID-19 vaccine, researchers set off to explore other disease areas with similar RNA vehicles. miRecule, a US biotechnology company, is on a different path, leveraging advances in RNA therapeutics to find treatments for rare diseases.

Today, Sanofi and miRecule are joining forces to pioneer innovative approaches in rare diseases and drive the creation of new medicines for patients in need.

In 2022, Sanofi announced its partnership with miRecule, combining Sanofi’s experience and best practices with the biotech’s speed and ability to drive novel therapies forward. And according to miRecule CEO Anthony Saleh, we’ve only seen the beginning of the exciting potential of RNA therapeutics.

 “As we learn more about patient genetics and data analytics, we can more quickly design and discover new RNA therapies,” said Saleh.

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Emergent BioSolutions Awarded 10-Year BARDA Contract Valued at up to a Maximum of $704 Million for Advanced Development and Procurement of Ebanga™ Treatment for Ebola
 

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

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Baltimore’s AsclepiX Therapeutics Raises $10 Million to Advance Clinical Study
 

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)

BALTIMORE, MD, July 26, 2023– AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor.

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Virginia Workforce Award to AMPEL BioSolutions
 

Virginia officials recognized AMPEL BioSolutions today for their dedication to identifying, training, and retaining STEM-trained workers, especially in the area of precision medicine.

The annual Virginia Talent + Opportunity (V-TOP) award is given on National Intern Day to employers who provide work-based learning opportunities, particularly to interns, who are essential to Virginia’s economy and play a crucial role in developing the necessary skills for career success, as stated by Kirk Cox, President of VA Bus Higher Ed Council. Internships are the foundation for workforce development.

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Global Breakthroughs for a Healthier Future – Registration for the 9th Annual BioHealth Capital Region Forum Now Live
 

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme “Global Breakthroughs for a Healthier Future.” After a period of remote events, we’re thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

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Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Charlottesville’s RIVANNA receives $30.5 million from BARDA to advance the Accuro XV musculoskeletal imaging system
 

CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.

“Completing our base-stage performance milestones ahead of schedule is a testament to our organization’s dedication and commitment to healthcare innovation,” said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV’s product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort,” added Le Roux.

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Virginia’s Solar Biotech Acquires VC-Backed Digital Biotech Noblegen
 

NORTON, Va. and PETERBOROUGH, ON, July 25, 2023 /PRNewswire/ – Solar Biotech Inc., a Norton, Virginia-based provider of complete sustainable and scalable biomanufacturing solutions, continues to build out its vertically integrated organization by acquiring Noblegen, an advanced digital biology company based in Peterborough, Ontario, Canada.

Noblegen will now operate under the name Solar Biotech Canada, continuing as the organization’s food-grade-certified (SQF9) biomanufacturing and research & development hub in Canada. The new company will leverage both partners’ strengths in microbiology and biomanufacturing to offer revolutionary biotech and synthetic biology (“SynBio”) solutions for a wide range of applications.

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United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
 

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

 

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Fierce Biotech: Previous Crab Trap Winner Galen Robotics nets FDA de novo clearance for ENT surgery helper
 

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

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Apply Now for the 6th Annual BioHealth Capital Region Investor Conference: Uniting Visionary Entrepreneurs and Pioneering Investors for Transformative Funding
 

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference’s history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

 

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All Rights Reserved.

 
 

 

 

567th Edition, July 25, 2023

By BHI Weekly News Archives

 

 

 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
 
  • Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S. government to transition to post-approval procurement

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of CYFENDUS™ vaccine is symbolic of Emergent’s longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent’s scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

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FinaBio’s Andrew Lees Wins Derek Horton Award in Industrial Carbohydrate Chemistry
 

Andrew Lees has received The Derek Horton Award in Industrial Carbohydrate Chemistry for outstanding contributions to industrial carbohydrate chemistry.

The Derek Horton Award in Industrial Carbohydrate Chemistry is awarded by the CARB division of the American Chemical Society and acknowledges distinguished achievements in and outstanding contributions to industrial carbohydrate chemistry.  Lees’ award was for his contributions to the field of protein polysaccharide conjugate vaccines, including the development of CDAP chemistry and a low-cost CRM197 carrier protein.

Andrew Lees is the founder and CEO of Fina Biosolutions, LLC (Rockville, MD), a company focused on promoting affordable conjugate vaccines, a class which includes vaccines for S. pneumoniae and meningococcal disease. Among his contributions to the field, Dr. Lees developed CDAP chemistry for activating carbohydrate hydroxyls, allowing for the efficient linking of proteins to polysaccharides. The chemistry has helped to reduce the cost of these vaccines as proteins can be directly coupled to CDAP-activated polysaccharides, eliminating many manufacturing steps. CDAP has largely replaced the older cyanogen bromide method and is now widely used in conjugate vaccines. CDAP chemistry also scales more easily than other conjugation chemistries and has enabled the manufacture of the Serum Institute of India’s low-cost pneumococcal and meningococcal vaccines, Pneumosil® and MenFive®, respectively. At Fina Biosolutions, Dr. Lees also introduced a low-cost version of CRM197, a genetically detoxified diphtheria toxin commonly used as the protein component of protein-polysaccharide conjugate vaccines, increasing access to the protein for both basic research and vaccine manufacturers.

Before starting Fina Biosolutions in 2006, Dr. Lees was Director of Vaccine Development at biotech companies Virion Systems, Inc (1993-1999) and Biosynexus, Inc (1999-2006). He was also an associate research professor at the Uniformed Services University (1993-1999). Andrew is now an adjunct professor at the University of Maryland School of Medicine Center for Vaccine Development, the Uniformed Services University, Dept. of Medicine, and the University of Toledo, Dept of Chemistry. He has over 75 publications and 25 patents, primarily in the subject area of conjugate vaccines. He received his BS in chemistry from Harvey Mudd College in chemistry (1976) and his Ph.D. in Biophysics from Johns Hopkins (1984). Honors include the Uniformed Services Meritorious Service Award, the Harvey Mudd College Outstanding Alumni Award, and the Johns Hopkins University Distinguished Alumnus Award. On graduating from Hopkins, he was on the cover of Baltimore Magazine as one of “84 people to watch in ‘84” due to his role as a leading Baltimore area magician.

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Fierce Biotech: Previous Crab Trap Winner Galen Robotics nets FDA de novo clearance for ENT surgery helper
 

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

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TEDCO Announces FY24 Board of Directors
 

Talented, diverse, and experienced leaders tapped to support Maryland’s economic engine for technology companies

 

COLUMBIA, Md. (July 20, 2023) – TEDCO, Maryland’s economic engine for technology companies, held its annual election for the board of directors’ executive officers, reaffirming another term for Chair Omar Muhammad of Morgan State University (MSU).

TEDCO’s full slate of executive officers are:

“I’m excited to continue serving on the board of directors. Our work has focused on supporting TEDCO’s mission of creating an enhanced, diverse and inclusive ecosystem throughout the state, and we look forward to continuing this mission through the various resources and programs TEDCO has to offer,” said Omar Muhammad, chair of the board. “In particular, I am excited to move forward with the Cultivate Maryland initiative, a major project that will support the growth of a diverse innovation economy thereby increasing Maryland’s competitiveness as an innovation economy and supporting larger retention and attraction of trained workers.”

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Baltimore’s Vita Therapeutics Collaborates with MilliporeSigma to Advance Preclinical Program for Vita’s Preclinical Cell Therapy for Limb-Girdle Muscular Dystrophy (LGMD2A)
 

Licensing agreement utilizing MilliporeSigma’s CRISPR genome-editing technology supports the advancement of Vita’s pipeline

‍Baltimore, MD, July 18, 2023 – Vita Therapeutics, Inc. today announced a licensing agreement between Vita and MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Under the agreement, Vita will leverage MilliporeSigma’s foundational CRISPR patents to advance the development of its preclinical asset VTA-100 for the treatment of limb-girdle muscular dystrophy (LGMD2A). Financial and other terms of the agreement were not disclosed.

“Our purpose is to impact life and health with science, empowering customers to deliver breakthroughs such as Vita’s impactful, health-advancing research,” said Christopher Arnot, Director of Licensing and Business Development, Gene Editing, MilliporeSigma.

“For people with limb-girdle muscular dystrophy, the calpain 3 (CAPN3) gene is mutated in satellite cells,” said Douglas Falk, MS, Chief Executive Officer at Vita Therapeutics. “MilliporeSigma’s proprietary CRISPR genome-editing technology will allow us to insert a functional copy of the gene into those cells, taking us an important step forward in advancing the development of VTA-100 as a potential cell therapy.”

 

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All Rights Reserved.

 
 

 

 

566th Edition, July 18, 2023

By BHI Weekly News Archives

 

 

 

Introducing the NCI Small Business Transition Grant: A Pathway for Academic Scientists to Entrepreneurship
 

The Small Business Transition Grant application period is now open, providing a valuable opportunity for early-career academic scientists to transition into entrepreneurship. Graduating students and postdoctoral researchers who have engaged in technology discovery during their academic pursuits and are prepared to embark on a small business venture are encouraged to apply. The eligible technology must fall under one of the following categories: therapeutics and preventive agents, imaging technologies, interventional devices, and in vivo diagnostics, as well as in vitro and ex vivo diagnostics and prognostics.

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NasaClip Unveils Groundbreaking Baltimore-Made Medical Device Transforming Nosebleed Treatment with Hands-Free Compression
 

New Device Provides an Effective, Hands-Free Solution to Stop Nosebleeds in Children and Adults

Adult and Pediatric NasaClip Sizes Provide Easy-To-Use Options for Chronic Nosebleed Sufferers, Healthcare Professionals, Parents, and Schools; First Available, U.S. Food and Drug Administration Registered Device with Age-Appropriate Sizing for Patients Aged 2 and Older

BALTIMORE, MD. (PRWEB) JULY 11, 2023

NasaClip, Inc., a Baltimore-based medical device company focused on improving the lives of patients with nosebleeds and the healthcare professionals who treat them today introduced the NasaClip, an easy-to-use device that provides constant, comfortable hands-free compression combined with intranasal sponges to stop nosebleeds quickly. NasaClip comes in an adult size for ages 14+, and pediatric size for children ages 2 to 13. It is the first nosebleed rescue device that provides adjustable nasal compression for children and adults and is registered with the U.S. Food and Drug Administration (FDA).

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University System of Maryland Momentum Fund Invests in Impruvon Health Alongside TCP Venture Capital, New Dominion Angels
 

Baltimore-based Digital Health Startup is Working to End Medication Errors and Streamline Workflows in Long-Term Care Settings

Baltimore, Md. (July 11, 2023) – Impruvon Health (“Impruvon”), a Baltimore-based digital health startup, announced today that it closed a financing round to support surging demand from healthcare organizations for its enterprise medication management platform. The round is led by The Propel Baltimore Fund from TCP Venture Capital, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and New Dominion Angels.

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BizJournals: Johns Hopkins University partnership with the Maryland Innovation Initiative looks to eliminate risks mosquitoes bring
 

By Tammi Thomas – Chief Development and Marketing Officer – TEDCO July 15, 2023, 06:00am EDT – Summer is upon us. Warmer months in the mid-Atlantic often conjure thoughts of flowers, trips to the beach or lake, and backyard cookouts. However, these increased temperatures also mean the emergence of annoying pests, like the mosquito.

Most of us associate mosquitos with mean red, itchy welts and having to bring insect repellents along on outdoor adventures. However, for others, particularly those living in hotter, more humid climates, mosquitoes are more than pests – they can be deadly transmitters of viruses such as malaria, dengue, yellow fever, Zika virus fever or West Nile fever.

Mosquitoes are one of many vectors – insects that can transmit infectious pathogens among humans, or from animals to humans. According to the World Health Organization, “vector-borne diseases account for more than 17% of all infectious diseases, causing more than 700,000 deaths annually.”

This is where Maryland Innovation Initiative (MII) awardee George Dimopoulos, Ph.D., MBA, is stepping in. A professor of molecular microbiology and immunology at Johns Hopkins University’s Bloomberg School of Public Health, Dimopoulos is studying vector-borne diseases and possible ways to render mosquitoes – what he deems “the deadliest animal on the planet” – incapable of transmitting human pathogens.

His research could help to reduce the number of vector-borne diseases. With the aid of a grant from MII, Dimopoulos is seeking to commercialize a nontoxic, environmentally friendly biopesticide. He has developed a cost-effective biopesticide that can target and kill adult and larval stages of mosquitoes and other agricultural pests, such as the Western corn rootworm that causes more than $1 billion in damages each year.

Click here to read more via the BizJournal.(subscription may be required)

 

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NIH 2023 SBIR and STTR Omnibus Notices of Funding Opportunity Have Been Published
 

Applicants are encouraged to review the 2023 SBIR and STTR Omnibus Notices of Funding Opportunity (NOFOs).These NOFOs encourage small businesses to submit grant applications to NIH, CDC, and FDA for innovative ideas across the HHS mission space. The new NOFOs are listed below:

 

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BARDA seeks Consortium Management Firm to run new Rapid Response Partnership Vehicle
 

Responding faster and more effectively to future public health challenges and emergencies will require the development of a specific, rapid acquisition vehicle. To achieve this, BARDA is launching the Rapid Response Partnership Vehicle (RRPV), the next generation of acquisition partnering to support U.S. health security.

In alignment with objectives outlined in the 2022-2026 Strategic Plan, BARDA seeks to leverage its Other Transaction Authority (OTA) to develop the RRPV. The RRPV will complement BARDA’s existing acquisition vehicles such as the Broad Agency Announcement (BAA) and the Easy Broad Agency Announcement (EZ-BAA) and will expand the mechanisms through which BARDA can rapidly partner with product developers prior to and during an emergency response. With the RRPV in place, BARDA will be able to leverage OTA agreements to meet the dynamic needs of the BARDA mission through a streamlined, expedited process.

 

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Maryland Tech Council Announces New Chair and Board
 

The Maryland Tech Council, the largest technology and life sciences trade association in the state, today welcomed a new chair and slate of technology and life sciences leaders to its board of directors. The new members join the board as MTC enjoys rapid growth in its membership, educational programs, and workforce development initiatives.

“I am thrilled to welcome these new members, who represent some of the most respected companies in Maryland’s innovation ecosystem,” said Kelly Schulz, CEO of the Maryland Tech Council. “Our ability to educate, connect, and advocate for members depends on diverse perspectives from creative and forward-thinking board members. I look forward to working with our board as we seek to make our state the destination of choice for innovators.”

 

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Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 

565th Edition, July 11, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

Building Better Medicine, and Transformative Partnerships: Insights from Joy Polefrone, Ph.D. on BioTalk
 

Ever wondered how public-private partnerships can make a significant difference in the field of life sciences? Curious about the goals, expected impacts, and timeline of the Alliance for Building Better Medicine (ABBM)? Interested in exploring the transformative potential of the Virginia BioHealth ecosystem and its role in advancing the life sciences industry?

Listen now via your favorite podcasting platform:

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BioHealth Innovation and Fhi 360 collaborate in developing a Life Science Tech Transfer and Commercialization Center in Sfax, Tunisia
 

The long-awaited grand opening of the Sfax University Simulation Center has finally arrived, marking a new era of innovative learning and development in Sfax, Tunisia. The cutting-edge center promises to provide a hub for experiential learning, creating a springboard for high-potential projects to flourish. In the run-up to the opening, the team at the Simulation Center, supported by Johns Hopkins University,  held a series of fruitful meetings with local stakeholders. During these sessions updates were shared, and attendees were encouraged to submit their high potential projects for consideration, initiating direct engagement with the local community.

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Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Children’s National Hospital, Virginia Tech unite to advance AI for pediatric health
 

Expectations are high for combining human and artificial intelligence against health problems.

“Start by determining the problem you desire to solve, then decide on the technology to solve it,” said Subha Madhavan, vice president and head of clinical artificial intelligence/machine learning with global biopharmaceutical company Pfizer. 

Madhavan was the keynote speaker at AI for Pediatric Health and Rare Diseases, an inter-institutional meeting of scientists and innovators co-led by Children’s National Hospital and the Virginia Tech Sanghani Center for Artificial Intelligence and Data Analytics to discuss the potential of artificial intelligence (AI) to understand pediatric health.

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George Mason University/USDA team find probiotics may play a pivotal role in preventive medicine
 

George Mason University/USDA team find probiotics counter high fat diets in pigs

FAIRFAX, Virginia – According to a new study published by George Mason University researchers Dr. Robin Couch and Dr. Allyson Dailey, in collaboration with researchers at the U.S. Department of Agriculture (USDA), showed probiotics may play a pivotal role in preventive medicine.

High fat diets are a leading cause of obesity and can trigger the onset of metabolic syndrome. The research team found that probiotic intervention has significant potential for addressing obesity-related diseases.

 

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Theradaptive Awarded Manufacturing Assistance Grant by the Maryland Stem Cell Research Fund
 

FREDERICK, Md., July 6, 2023 /PRNewswire/ — Today, Theradaptive, a biopharmaceutical firm pioneering advancements in targeted regenerative therapeutics, has been awarded the Manufacturing Assistance Program grant by the Maryland Stem Cell Research Fund (MSCRF). The grant will help Theradaptive develop their GMP Manufacturing Facility in Frederick, stimulating economic development in the state and bolstering Maryland’s reputation as a hub of biotechnological innovation.

Theradaptive seeks to significantly improve patient outcomes by producing targeted therapeutics that can be used to coat implants, devices, and injectable carriers. Their proprietary protein-engineering platform aims to provide greater efficacy, safety, and ease of use across multiple clinical indications including orthopedics, immuno-oncology and dental.

 

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MarylandToday: $4.4M NIH Award Supports UMD Research on Enzymes to Combat Pneumonia
 

The National Institutes for Health (NIH) has awarded $4.4 million to a University of Maryland researcher and a colleague to develop both a novel therapeutic and a vaccine approach to address Streptococcus pneumoniae, which is the leading cause of bacterial community-acquired pneumonia and the cause of death for about 1.6 million people annually.

Pneumococcal vaccinations are very effective, but target just a few of the more than 100 different strains of pneumococcus; they’re also unavailable in many developing countries. Additionally, antimicrobial resistance is on the rise globally, and poses a risk of pneumococcal disease that is increasingly difficult to combat.

 

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BioFactura and CuraTeQ Sign Exclusive License for BFI-751—A Biosimilar to Stelara
 

FREDERICK, MARYLAND, July10, 2021: BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used for treating Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The global drug sales of Ustekinumab stood at close to 10 billion in 2022 presenting a significant opportunity with a good number of indications and a wider use.

 

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MaxCyte and Vittoria Biotherapeutics Sign Strategic Platform License to Advance Next Generation Cellular Therapies
 

MaxCyte’s Flow Electroporation® technology and ExPERT™ platform will support Vittoria’s Senza5™ technology to enhance efficacy and improve clinical utility of T-cell therapies.

ROCKVILLE, Md. and PHILADELPHIA, July 10, 2023 (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 to support innovative, cell-based research, and Vittoria Biotherapeutics (Vittoria), a leading edge, gene-edited cell therapeutics company with novel platform technologies poised to develop a pipeline of highly differentiated cellular therapies for both oncology and immunology indications, today announced the signing of a strategic platform license (SPL) of MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to Vittoria Biotherapeutics.

 

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MaxCyte Signs Strategic Platform License with Lyell Immunopharma
 

Lyell Immunopharma to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform in its T cell product candidates targeting solid tumors.

ROCKVILLE, Md., July 06, 2023 (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 to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Lyell Immunopharma, Inc., a clinical stage T cell reprogramming company.

 

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BARDA seeks Consortium Management Firm to run new Rapid Response Partnership Vehicle
 

Responding faster and more effectively to future public health challenges and emergencies will require the development of a specific, rapid acquisition vehicle. To achieve this, BARDA is launching the Rapid Response Partnership Vehicle (RRPV), the next generation of acquisition partnering to support U.S. health security.

In alignment with objectives outlined in the 2022-2026 Strategic Plan, BARDA seeks to leverage its Other Transaction Authority (OTA) to develop the RRPV. The RRPV will complement BARDA’s existing acquisition vehicles such as the Broad Agency Announcement (BAA) and the Easy Broad Agency Announcement (EZ-BAA) and will expand the mechanisms through which BARDA can rapidly partner with product developers prior to and during an emergency response. With the RRPV in place, BARDA will be able to leverage OTA agreements to meet the dynamic needs of the BARDA mission through a streamlined, expedited process.

 

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564th Edition, July 6, 2023

By BHI Weekly News Archives






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July 06, 2023

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Trailblazing in the BioHealth Capital Region: A Conversation with MedTech Innovator Accelerator Company Leaders

Join us on a compelling episode of BioTalk as we sit down with three dynamic leaders from groundbreaking MedTech companies based in the thriving BioHealth Capital Region. These companies, JuneBrain, Xcision Medical Systems, and Sonavi Labs, were recently selected for the prestigious MedTech Innovator Accelerator, the world's largest accelerator of medical technology companies. Discover their innovative solutions and the transformative impact they are making in healthcare.

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Emergent BioSolutions Announces CEO Transition

GAITHERSBURG, Md., June 27, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions (NYSE: EBS, “Emergent” or the “Company”) today announced that Robert G. Kramer Sr. has informed the Board of Directors of his intention to retire from Emergent. Mr. Kramer will step down from his role as President and CEO of Emergent and as a member of the Company’s Board, effective immediately. The Board has appointed Haywood Miller as interim CEO while it conducts a search to identify a new permanent CEO, considering both internal and external candidates and with the assistance of a leading executive search firm. Mr. Miller, Managing Director at Berkeley Research Group (“BRG”), has served as an advisor to the Company and its executive management team for the last several months. In order to ensure a smooth transition, Mr. Kramer will serve as an advisor to the Company until August 1, 2023.

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TEDCO Seed Funds Invest in Galen Robotics, Inc.

Galen Robotics, Inc. was the winner of the 2018 BioHealth Capital Region Crab Trap Competition

COLUMBIA, Md. (June 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Seed Funds investment into Galen Robotics, Inc. This round of seed funding is from the Life Sciences Investment Fund.

Bruce Lichorowic, Galen Robotics CEO“In 2017, Galen successfully secured our first MII Phase III grant which led us to make the decision to relocate our headquarters from Silicon Valley to Baltimore. Now, as we receive a follow-up investment, it is evident that TEDCO remains committed to supporting and nurturing its portfolio companies. Despite the macroeconomic challenges associated with early-stage funding, TEDCO has established itself as a leader in investing in high-quality startups based in Maryland. Their dedication to supporting local entrepreneurship is commendable and sets them apart in the startup ecosystem,” said Bruce Lichorowic, president and CEO of Galen Robotics. “TEDCO serves as a valuable resource for Maryland's early-stage technology companies, offering not only funding opportunities but also mentorship, marketing strategies and introductions to key leaders within the government and industry. With these comprehensive support services, TEDCO becomes an indispensable resource that empowers startups to progress and reach the next level of their development.”

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George Mason University/USDA team find probiotics may play a pivotal role in preventive medicine

George Mason University/USDA team find probiotics counter high fat diets in pigs

FAIRFAX, Virginia – According to a new study published by George Mason University researchers Dr. Robin Couch and Dr. Allyson Dailey, in collaboration with researchers at the U.S. Department of Agriculture (USDA), showed probiotics may play a pivotal role in preventive medicine.

High fat diets are a leading cause of obesity and can trigger the onset of metabolic syndrome. The research team found that probiotic intervention has significant potential for addressing obesity-related diseases.

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563rd Edition, June 20, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

From Vision to Action: MEDCO’s Role in Economic Development and Partnerships on BioTalk with Rich Bendis
 

In this captivating episode of BioTalk, Rich Bendis sits down with Tom Sadowski, the Executive Director of the Maryland Economic Development Corporation (MEDCO). With over 30 years of experience in economic development, Tom has played a pivotal role in translating vision into action. Together we explore MEDCO’s significant contributions to economic development and their strategic partnerships across Maryland.

Tom shares his remarkable career accomplishments, including successful projects valued at over $10 billion and the creation of 50,000 jobs. His expertise in fostering research partnerships, technology commercialization, and his role in launching the Maryland Momentum Fund bring invaluable insights to the conversation. We uncover MEDCO’s focus on real estate development, financing, infrastructure, and public/private partnerships, all aimed at fueling business retention, development, and employment growth.

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BHI and KOSME Foster Korean Companies’ US Market Entry Program for the Third Consecutive Year Beginning June 20th, 2023
 

BioHealth Innovation, Inc. (BHI), in collaboration with the Global Business Center (GBC) – Washington, D.C. of Korea SMEs and Startups Agency (KOSME), is excited to announce the continuation of their highly successful program aimed at facilitating Korean companies’ entry into the US market. As the program enters its third year, it continues to empower Korean biotech enterprises, enabling them to establish a strong foothold in the BioHealth Capital Region. KOSME is a Korean-government funded non-profit, currently led by President, Dr. Hakdo Kim, created over forty years ago to support small and medium enterprises in Korea.

“We are thrilled to continue our partnership with BHI for the third year in a row. The program has consistently provided guidance and market knowledge, proving invaluable to Korean biotech companies. We anticipate that our latest cohort will benefit greatly from this collaboration,” says Rich Bendis, President and CEO of BHI.

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Welcome Ashleigh Acker and Sebastian Chung: BHI’s Newest Interns
 

BioHealth Innovations (BHI) is thrilled to welcome Ashleigh Acker and Sebastian Chung as the newest additions to our internship program. Their diverse backgrounds and passion for biotechnology make them valuable assets to our organization.

Sebastian Chung, a graduate student at Johns Hopkins University, is on track to complete his Master’s in Biotechnology in the spring of 2024. During his undergraduate years at the University of Washington in Seattle, Sebastian excelled in the study of physiology and sales, all while co-captaining the men’s club golf team. His expertise lies within the multi-omic space, having worked as an account manager at NanoString Technologies, a leading biotechnology company. Sebastian’s extensive experience in consulting on sequencing and spatial biology projects, particularly with large pharmaceutical companies in the greater New England area, will undoubtedly contribute to our innovative research initiatives. When he’s not immersed in the world of biotechnology, Sebastian enjoys playing golf and watching premier league soccer.

 

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AlphaTech Welcomes Diverse Cohort of Emerging Companies with Live Event
 

AlphaTech, an esteemed initiative focused on fostering innovation within the cybersecurity, big data, analytics, and digital health sectors, is thrilled to announce the induction of a new cohort consisting of exceptional companies. The program, designed to engage with Founders and CEOs of emerging growth companies, aims to provide valuable resources, educational programming, networking opportunities, and meaningful interactions.

Over the course of eight months, this select group of CEOs will have the privilege of connecting with AlphaTech’s advisors, speakers, alumni, and industry luminaries. The program’s comprehensive approach encourages collaboration and knowledge sharing, ensuring participants gain insights from experienced professionals and industry veterans.

 

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2022 BHCR Crab Trap Winner Neuroene Therapeutics Receives NIH SBIR Award for Novel Antiseizure Drug with Potential for Public Health Emergency Response
 

Neuroene Therapeutics has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH). The award supports Neuroene’s ongoing research and development of a novel class of well-tolerated compounds protects and ameliorates mitochondrial and neurological diseases.

Neuroene’s lead antiseizure drug (ASD) candidate has demonstrated broad-spectrum antiseizure activity in several animal models of pharmacoresistant seizures and Parkinson’s disease, showcasing its potential both as a fast-acting rescue agent and long-term chronic therapeutic. Intriguingly, the compound’s stability offers significant advantages for long-term storage and stockpiling in case of public health emergencies or bio-incidents.

 

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TDR: Frederick’s Theradaptive Closes $26M Series A
 

Frederick-based biopharmaceutical company Theradaptive Thursday announced it has closed a $26 million Series A funding round to advance development of its targeted regenerative therapeutics.

The funds are intended to enable the company to continue its work to meet regulatory requirements and scale up Good Manufacturing Practices in preparation for first-in-human clinical trials later this year. Investment will also support the expansion of the Theradaptive platform beyond orthopedics to additional indications such as oncology and dental. The round brings Theradaptive’s total funding to more than $50 million.

The company has previously been awarded non-dilutive grant funding from the Department of Defense, as well as the Maryland Stem Cell Research Fund.

Click here to read more via The Daily Record.

 

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NIH Releases Licensing Public Health & Economic Impact Study
 

The long-anticipated intramural licensing impact study was officially released in conjunction with the BIO Annual Meeting and is now posted to a special section of the NIH Community Tech Transfer Website for further reading and utilization.

The year-long study involved a full download and analysis of NIH TechTracs licensing data and demonstrates the true impact and power that our NIH intramural licensing program has had in three major areas:

 

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TEDCO Announces Recent Investment in Aidar Health, Inc.
 

Maryland health technology company developing innovative medicine solutions to promote more personalized care

 

COLUMBIA, Md. (June 14, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $250,000 into Aidar Health, Inc., a health technology and digital medicine company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provide access to gap financing.

 

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Addimmune

562nd Edition, June 13, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

citybiz: American Gene Technologies Launches New Spinoff Company “Addimmune” to Focus Exclusively on Development of HIV Cure
 

Addimmune will build upon the success of American Gene Technologies Phase 1 HIV clinical trial, accelerating the clinical development with dedicated investment and singular focus on HIV.

American Gene Technologies, a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company — Addimmune — to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.

Addimmune aims to create tremendous benefits for HIV patients, payers, and the public. Its gene therapy technology has the power to transform millions of lives. The new company’s name represents a fusion of two fundamental concepts: using gene and cell therapy to add new capacity to the human T cell to create an improved immune system to fight HIV.

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TEDCO Invests SSBCI Funding into Hememics Biotechnologies, Inc.
 

Maryland biotech company revolutionizing point-of-care testing for viruses and environmental toxins

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a $500,000 State Small Business Credit Initiative (SSBCI) investment into Hememics Biotechnologies, Inc., a biotechnology company. The investment came through TEDCO’s Venture Funds.

“I am extremely proud of what the company has achieved,” said John Warden, Jr., CEO and co-founder of Hememics Biotechnologies, Inc. “We have generated favorable results from more than 100,000 biosensor tests in the past nine months. The new funding will allow us to put the final touches on our product, and continue to develop early commercial customers.”
Hememics Biotechnologies, Inc., based in Gaithersburg, Md., is using graphene monolayer biosensors to revolutionize point-of-care testing for viruses and environmental toxins. The HemBox™, a cellphone-sized reader and chip platform, allows users to test for multiple viruses and toxins from samples as diverse as soil, water, saliva and blood.

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University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) signs MOU with Korean Regulatory Science Center
 

On Monday, June 5, 2023, members of the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) met with Korean Regulatory Science Center (KRSC) members Dr. In-sook Park and Mi-rim BaekDr. Kyenghee Kwon, a representative from Dongguk University, was also in attendance. The meeting was hosted by Dr. Jim Polli, M-CERSI Co-Director, at the University of Maryland, Baltimore, in the School of Pharmacy building. 

“It is an exciting endeavor to work with the Korean Regulatory Science Center and its universities,” said Dr. Bill Bentley, M-CERSI Co-Director. “I am delighted to see M-CERSI’s success inspire others.” 

At the meeting, the KRSC expressed interest in sending students to participate in UMB’s Master of Science and Graduate Certificate in Regulatory Science, in addition to learning more about the projects, financials, and activities of M-CERSI to learn how to run a similar organization in Korea. 

The KRSC team plans to host their own version of M-CERSI’s America Got Regulatory Science Talent Competition in July, with eight universities and colleges participating. The KRSC competition, open to undergraduate students, has more than 17 teams formed already. The goals of the competition are to spread positive regulatory science awareness and encourage the next generation of scientists.

Click here to read more.

 

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PQE Group sets the pace for new FemTech related services, empowering new development of therapies in the clinical space
 

Recently recognized as a Great Place to Work in the US for the second consecutive year, PQE Group, the woman-owned global consulting company, announces its mission towards innovation in the development of therapies for women’s health challenges.

A year after the foundation of GQC, an internal start-up of the Group focused on medical cannabis therapy solutions, Gilda D’Incerti – CEO and Founder of the company – is now dedicating her interest to FemTech (Female Technology) and the so-called SHEconomy: these primary market trends forecast tremendous growth in terms of profit and growth in the next decade, accelerating drug development for women’s health and well-being.

 

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TEDCO signs partnership intermediary agreement with the National Cancer Institute Technology Transfer Center
 

New agreement will allow more collaboration to advance technology and life sciences innovations across the state

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced the signing of a Partner Intermediary Agreement (PIA) with the National Cancer Institute Technology Transfer Center (NCI TTC).

“NCI and TEDCO have collaborated for more than a decade on a variety of initiatives to bring the latest advancements in cancer research and technology to the public through Maryland businesses. These collaborations have helped create a thriving innovation ecosystem that benefits both patients and the economy,” said Tom Stackhouse, PhD, director, NCI TTC.
This agreement will codify the relationship between NCI and TEDCO, allowing the two organizations to help promote and foster more opportunities for Maryland’s life sciences community to work together with NCI on cooperative research.

 

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TEDCO Announces an SSBCI Investment into Nanocrine
 

Maryland biotechnology company creating methods for more efficient and reliable research

COLUMBIA, Md. (June 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of $300,000 into Nanocrine, a biotechnology company.

“Without a steady and reliable foundation, research can be unreliable and unpredictable,” said Patrick Calhoun, president and chief science officer of Nanocrine. “Unfortunately, this is where many researchers are when studying living cells; many surfaces that cells interact with are uncharacterized or not made with appropriate lab-specific protocols—Nanocrine is working to change this and advance the scientific research and exploration of living cells.”

 

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OPEN CHALLENGE – BLUE KNIGHT QuickPitch: Activating for the Future
 

Recent global disease outbreaks have had devastating impacts, triggering a renewed emphasis on preparation for potential known and unknown health threats. By proactively enhancing preparedness against emerging pathogens, we aim to minimize the scale of future outbreaks, protect vulnerable populations, and ultimately safeguard our health security. 

To that end, Johnson & Johnson Innovation, together with the Biomedical Advanced Research and Development Authority (BARDA), is proud to launch the BLUE KNIGHT™ QuickPitch: Activating for the Future. Innovators are invited to submit potentially ground-breaking ideas or technologies that aim to enhance preparedness toward future known and unknown health threats, including emerging pathogens.

Up to 10 innovator(s) with the best potential solution will earn the opportunity to pitch to a panel of industry experts including Johnson & Johnson and BARDA leadership at JLABS @ Washington, DC on August 29. ** In addition, applicants may be invited to join Blue Knight through residency at the hub at JLABS @ Washington, DC, based on their applications and/or presentations.

**No travel costs will be reimbursed for applicants to attend live pitch event in Washington, DC.

For more information on this challenge, click here.

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CBRE2023talent

561st Edition, June 6, 2023

By BHI Weekly News Archives

 

 

 

 

 
 

BioHealth Capital Region Secures Top 3 Spot in CBRE’s 2023 Life Sciences Talent Report Amidst Booming Industry Growth
 

The CBRE Life Sciences Research Talent 2023 Report underscores the BioHealth Capital Region’s consistent position in the top three hotspots for life sciences talent in the United States. The report reveals a booming life sciences industry, with a record number of individuals graduating with degrees in biological and biomedical sciences. Over the past two decades, the number of life science professionals in the U.S. increased by 79%, in contrast to the 8% growth rate across all other occupations. This trend has led to the fastest pace of industry growth on record, particularly rebounding after a downturn in 2020.

Among the specific roles and jobs within the sector, medical scientists have seen the greatest increase. However, the report also notes a fierce competition for talent, with the industry facing a “furious search for talent” to meet escalating demands for its products and services. Despite this overall growth and competitiveness across the country, the BioHealth Capital Region stands out for its ability to attract and retain top talent, as evidenced by its position in the top three.

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Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study
 

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer
Published: May 31, 2023

– HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US –

– Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity –

– PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations –

– PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors –

– Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease –

– CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials –

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CBIC of Virginia Names AMPEL BioSolutions as Innovator-of-Year
 

Charlottesville, VA – June 2, 2023 – The Charlottesville Business Innovation Council (CBIC) has awarded AMPEL BioSolutions, a leading data science company, with the prestigious “Innovator-of-Year” title. The recognition was given to AMPEL BioSolutions for the outstanding AMPEL Genomic Platform, which utilizes RNA analytics and Machine Learning for dynamic disease management, including flare prediction and personalized decision support for drug options.

AMPEL BioSolutions is currently in commercialization mode and making significant progress in executing its platform technology. This year, AMPEL is set to make LuGENE, a blood test, available nationwide in the United States through ReLATE. The CBIC award ceremony was a moment of celebration for the AMPEL team, who thanked Angel Williams Derricott, for her unwavering Advocacy for Lupus & celebrating with the AMPEL team at CBIC unwavering advocate for Lupus, joined.

 

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TEDCO’s The Leading Edge Special Feature at the University of Maryland, College Park, Highlighting MII Awardee
 

Three entrepreneurial leaders discuss the support available through the MII program

COLUMBIA, Md. (June 5, 2023) – TEDCO, Maryland’s economic engine for technology companies, released a new episode of its innovation series, TEDCO’s The Leading Edge. Throughout this series, TEDCO thought leaders host a fireside chat with entrepreneurs discussing their experiences, providing advice to aspiring entrepreneurs, and more.

In this episode, TEDCO’s Maryland Innovation Initiative (MII), UM Ventures and Innovate Maryland come together at the University of Maryland, College Park (UMCP) for a live fireside chat. The discussion included Arti Santhanam, PhD, MII executive director; Ken Porter, UM Ventures, College Park director and MII Board member; and Srinivasa Raghavan, PhD, MII awardee, UMCP professor of chemical and biomolecular engineering, and entrepreneur.

Throughout the discussion, the three leaders dove into the MII program and the various support avenues it provides, as well as the success Raghavan has seen throughout his time with MII.

“It’s really important [during] those early stages to have sources of support, not just funding…” said Raghavan. “That is [what’s] amazing about MII… you reach out to people who can support you… MII is a wonderful program… it is there for you, and it could really open doors and take you in a new direction.”

 

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Novavax Announces Agreement with Bill & Melinda Gates Medical Research Institute to Include Matrix-M™ Adjuvant as Potential Component in Vaccine Research
 

GAITHERSBURG, Md., June 5, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, has signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide its adjuvant for use in preclinical vaccine research.

“We are excited to partner with the Bill & Melinda Gates Medical Research Institute to include our unique technology in their public health-focused vaccine research efforts,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Our Matrix-M™ adjuvant is proven to enhance and broaden the immune system response when included in vaccines and is already a key component of COVID and malaria vaccines on the market today. We look forward to partnering more broadly with a variety of organizations so that our technology can benefit vaccine development across many disease areas.”

“The Bill & Melinda Gates Medical Research Institute is committed to developing biomedical interventions that address global health concerns for those in the greatest need,” said Emilio Emini, PhD, chief executive officer of the Bill & Melinda Gates Medical Research Institute. “We look forward to working with Novavax’s Matrix-M™ adjuvant in some of our early-stage vaccine programs.”

 

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BISNOW/MCEDC: With Multimillion-Dollar Acquisitions And Developments, Life Sciences To Boom In Montgomery County, Maryland
 

The life sciences industry is seeing tremendous growth in Maryland, particularly in the D.C. suburb of Montgomery County. With nearly $6B invested in life sciences ventures in 2021 alone and more than 40,000 life sciences workers in the state, Montgomery County is the anchor of the fourth-largest biotech hub in the U.S.

The county’s life sciences market continues to expand its footprint with more biotech and pharmaceutical companies setting up shop in Rockville and other areas, drawn in by its skilled workforce. Also fueling the growth is the Montgomery County Economic Development Corp., which helps companies expand, relocate or start in the county. 

“We have the skilled labor force, the support of local universities, the Maryland Tech Council and a diverse population to help expand life sciences not only in Montgomery County but the state of Maryland,” MCEDC Senior Vice President of Business Development Brad Stewart said.

 

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Biomedical innovation | Deloitte Insights – Unlocking the potential of biomedical innovation: The crucial role the government and partnerships play in accelerating progress
 

It was an extraordinary achievement. In less than one year, the biomedical ecosystem helped bring to life an mRNA vaccine with the power to stave off severe disease and death during the worst pandemic since 1918. Of course, this wasn’t really a miracle. It was just one example of what government and partners can do when challenged to develop disruptive innovations.

Government has been a disruptive force for innovation across many sectors, from Defense Advanced Research Projects Agency (DARPA) laying the foundation for the internet in the 1960s, to the role of the National Institutes of Health’s (NIH) and US Department of Energy in the Human Genome Project, which mapped the full genome for the first time in 2003 with an international consortium of thousands of researchers, to the U.S. President’s Emergency Plan for AIDS Relief initiative that has saved more than 25 million lives from HIV/AIDS across the globe.

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Biomedical innovation | Deloitte Insights – Unlocking the potential of biomedical innovation: The crucial role the government and partnerships play in accelerating progress

By News

Deloitte png 250It was an extraordinary achievement. In less than one year, the biomedical ecosystem helped bring to life an mRNA vaccine with the power to stave off severe disease and death during the worst pandemic since 1918. Of course, this wasn’t really a miracle. It was just one example of what government and partners can do when challenged to develop disruptive innovations.

Government has been a disruptive force for innovation across many sectors, from Defense Advanced Research Projects Agency (DARPA) laying the foundation for the internet in the 1960s, to the role of the National Institutes of Health’s (NIH) and US Department of Energy in the Human Genome Project, which mapped the full genome for the first time in 2003 with an international consortium of thousands of researchers, to the U.S. President’s Emergency Plan for AIDS Relief initiative that has saved more than 25 million lives from HIV/AIDS across the globe.

 

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Claire2

560th Edition, May 31, 2023

By BHI Weekly News Archives

 

 

 

 
 

BioHealth Innovation Welcomes Entrepreneur-in-Residence Claire Leurent, Ph.D. MBA at NIH’s SEED Program
 

Entrepreneurs-in-Residence (EIR) Team Continues Growth With National Institutes of Health (NIH)

ROCKVILLE, MARYLAND, May 30, 2023  BioHealth Innovation Inc. (BHI) proudly welcomes Claire Leurent, Ph.D. MBA, to its expanding Entrepreneurs-in-Residence (EIR) team. As part of BHI’s commitment to advancing disruptive technologies in healthcare, the Entrepreneur-in-Residence Program ensures that these innovations receive the necessary resources to transition from discovery to commercialization and make a measurable impact on human health. Claire will collaborate with the NIH Seed Program, supporting scientists, early-stage startups, and licensed technologies.

“We are excited to have Claire Leurent join our EIR team as we continue our collaboration with the National Institutes of Health,” said Richard Bendis, President and CEO of BHI. “Claire’s extensive expertise in venture capital investment and drug development perfectly aligns with our mission to drive innovation and transformative healthcare solutions.”

With a venture capital investor background and hands-on experience leading drug development from scientific discovery to registration studies, Claire Leurent is driven by her passion for science and dedication to improving lives through transformative technologies and business models. Her dynamic perspective and commitment to progress make her an invaluable addition to the BHI team.

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Emergent BioSolutions Announces the Execution of Contract Option to Deliver ACAM2000 into the Strategic National Stockpile
 

On May 26, 2023, Emergent BioSolutions Inc. (including its wholly-owned subsidiaries, “Emergent”), through its wholly-owned subsidiary, Emergent Product Development Gaithersburg Inc., received a contract modification from the Office of the Assistant Secretary for Preparedness and Response (“ASPR”), an agency of the U.S. Department of Health and Human Services (“HHS”), exercising and funding the third of nine annual contract term extension options (the “Third Option Exercise”) for Emergent to supply ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (the “SNS”). The Third Option Exercise is valued at approximately $120 million.

The Third Option Exercise was made under a bilateral modification of Emergent’s existing 10-year contract (the “Contract”) awarded by ASPR on August 30, 2019. The period of performance under the Third Option Exercise requires Emergent to deliver doses of ACAM2000 into the SNS by June 30, 2023.

The preceding description of the Third Option Exercise does not purport to be complete and is qualified in its entirety by reference to the Third Option Exercise. The Third Option Exercise, with relevant redactions to protect confidential and sensitive information, is expected to be filed as an exhibit to Emergent’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023. The Contract is filed as a material agreement of Emergent as exhibit 10.48 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

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Gaithersburg’s Adaptive Phage Therapeutics Enters Collaboration and License Agreement with Hebrew University of Jerusalem and Hadassah Medical Center
 

GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, is pleased to announce a collaboration and license agreement with the Israeli Phage Therapy Center (IPTC) of the Hebrew University of Jerusalem and Hadassah Medical Center. Researchers at the IPTC have discovered several phages that have exceptionally broad coverage against antibiotic resistant bacteria. Under the agreement, Hadasit and Yissum, the technology transfer companies of Hadassah and the Hebrew University, grants APT exclusive rights to make, use, and sell licensed phages for human therapy, with the right to sublicense through multiple tiers. APT also has the first right to evaluate additional phages discovered by IPTC researchers for inclusion in APT’s phage bank. As consideration for the license and first right of refusal, APT made an upfront payment and will pay royalties from net sales on any therapeutic composition comprising a licensed phage.

 

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Rockville’s REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome
 

ROCKVILLE, Md., May 23, 2023 /PRNewswire/ —REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for RGX-121, an investigational one-time AAV Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. RMAT designation is designed to expedite the drug development and review processes for promising new treatments, including gene therapies, and recognizes that the preliminary clinical evidence from RGX-121 indicates its potential to address unmet medical needs for MPS II. RGX-121 is currently being studied in the CAMPSIITE™ trial that is enrolling MPS II patients as part of a pivotal program that incorporates material from the NAVXpress™ platform process manufactured at the REGENXBIO Manufacturing Innovation Center and continues to support plans to file Biologics License Application (BLA) in 2024 using the accelerated approval pathway.

 

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ABL awarded seven-year NIH contract for continued support in HIV prevention products
 

Rockville, MD, United States, May 23, 2023 – Advanced BioScience Laboratories (ABL), a global Contract Development and Manufacturing Organization (CDMO) for biotherapies,
oncolytics and viral vector vaccines, today announces it has been awarded a contract for ‘Resources to Advance Pediatrics and HIV Prevention Science (RAPPS)’ by the Division of AIDS
(DAIDS) within the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH).

This seven-year contract has a total potential funding value of $98.9 million. ABL will provide DAIDS with (i) preclinical gap-filling, (ii) animal models, (iii) bioanalytical services, (iv)
product manufacturing and (v) other scientific and quality/regulatory services to support preclinical research, development of pediatric formulations and advancement of next generation non-vaccine Biomedical HIV Prevention products (nBPs) such as IntraVaginal Rings (IVRs), long-acting injectables and Multipurpose Prevention Technologies (MPTs) composed of a combination of drugs that can target prevention of pregnancy, Sexually Transmitted Infections (STIs) and/or HIV.

 

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Hememics Biotechnologies, Inc. Announces Successful Close in $2 Million Seed 2 Financing from TEDCO and Qualified Investors to Accelerate Growth
 

GAITHERSBURG, Md., May 25, 2023 /PRNewswire/ — Hememics Biotechnologies, Inc., developer of first-in-class, handheld, multiplexed biosensor platform that can test antibodies, antigens and molecular targets simultaneously, announced today the closing of a $2 million Seed 2 financing round. Participants of this round include a strategic investor, existing investors and Maryland Technology Development Corporation (TEDCO).

“I am extremely proud of what the company has achieved with the limited amount of resources,” said John Warden, Jr., CEO and Co-founder of Hememics Biotechnologies, Inc. “We have generated extremely favorable results from more than 100,000 biosensor experiments in the past nine months. The new funding will allow us to finalize our design, receive third-party validation, and develop early commercial customers.” 

 

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Technical.ly: Meet the Maryland innovators behind the state’s best 2023 inventions
 

What do you get when you combine a networking happy hour for STEM researchers, an engaging expert panel discussion and a host of exciting STEM inventions? The answer is one exciting event: the Maryland Innovation Initiative’s Pop-up at the University of Maryland, College Park (UMD) and Innovate Maryland: Invention of the Year Awards!

TEDCO and the Maryland Innovation Initiative (MII) were on hand to sponsor Innovate Maryland’s Invention of the Year Awards, held at The Hall on the University of Maryland’s College Park campus. Innovation was all around, encompassed by the various finalists and the Invention of the Year winner: a solar-powered system that uses all-natural, partly plant-based materials to extract drinkable water from the toughest environments.

Maryland is home to many talented researchers — in fact, it has the highest concentration of Ph.D.s of any state in the country, while also ranking #1 for its technology and science workforce. The MII recognizes the commercial possibilities coming out of the state’s creative faculty and supports these innovators by serving as a catalyst to both spur exciting startup projects at Maryland’s research universities and ignite an entrepreneurial mindset among faculty. Both of these elements were on

Click here to read more via Technical.ly

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TEDCO Announces Investment into Pathotrak
 

COLUMBIA, Md. (May 23, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a Venture Funds investment of $300,000 into Pathotrak, a biotechnology company.

Javier Atencia“Until Pathotrak, producers would need to wait for the results of pathogen tests, leading to costly warehousing and refrigeration costs,” said Javier Atencia, CEO and founder of Pathotrak. “Through our innovative solution, we are eliminating this need by cutting down the time it takes to get results, which will also help prevent costly recalls and food waste.”

Pathotrak, based in College Park, Md., is a business with the mission to create a world with fresher and safer food using cost-efficient innovative technology. This technology will allow the expedition of foodborne pathogen detection, providing companies and producers with faster results, and ultimately shortening what is typically a 22-hour process down to under six hours. This rapid detection process has the potential to decrease food waste, allowing products to be placed on shelves up to an entire day earlier while also reducing the costs of food production—from the costly warehousing and refrigeration processes to the expensive recalls.

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