• FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024
• Pivotal program is active and enrolling patients
• RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II
• Internal cGMP manufacturing process expected to support BLA

ROCKVILLE, Md., Aug. 3, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. The Company also announced that a pivotal program for RGX-121 is active and enrolling patients. RGX-121 is an investigational, one-time AAV Therapeutic using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme.

"We are pleased to share that our recent discussions with the FDA support our plans to submit a BLA for RGX-121 in 2024 using the accelerated approval pathway, which was created to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "We believe RGX-121 for the treatment of Hunter Syndrome has demonstrated emerging positive impact on neurodevelopmental function, and we intend to advance this program as quickly as possible with the aim of providing a much-needed new treatment option for the MPS II community."

The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses who have never received NIH SBIR/STTR funding in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application.

The goal of this program is to increase participation in the SBIR program by socially/economically disadvantaged small businesses, women-owned small businesses, and small businesses located in under-represented states.

The AAP application portal will be opening on August 5th, 2022 and information about the program is available at the NIH Application Assistance Program website. For more information about the AAP, be sure to attend the AAP Informational Webinar on August 5th at 3:00 PM ET and the Q&A Office Hours on September 15th at 2:00 PM ET. All applications must be submitted no later than September 22nd, 2022 at 5:00 PM ET.

Please note that this service is NOT available to support preparation of a Fast-Track or Phase II application. Companies who have a current SBIR/STTR application under review with the same scope of work are not eligible for AAP support.

Click here for more information.

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.

GlaxoSmithKline (GSK) has signed an agreement to reserve, produce, and supply its influenza vaccine Adjupanrix to 12 European countries.

Under the terms of the deal, GSK has signed a contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA), for the reservation of future manufacture of 85 million doses of Adjupanrix (split virion, inactivated, adjuvanted).

You are invited to our exclusive Biotech & Beer networking event at The Black Sheep Restaurant on August 16th from 4:30-6:30pm, where we will bring together our Northern Virginia life science community from academia, industry, and healthcare.

Learn about new resources available in Virginia to grow your research and development capabilities. Also, come hear about the latest in the life sciences by exchanging in conversation with with old and new friends!

Register to attend for free at: https://members.vabio.org/events/biotech-and-beer--nova/register

ROCKVILLE, MARYLAND, August xx, 2022 – BioHealth Innovation Inc. (BHI) is pleased to welcome Kelly Murphy, M.S., as a new Life Sciences Business Strategist. In this role, Murphy will evaluate the commercial potential of clients’ emerging technologies and assist start-ups with their go-to-market strategies. Her work will also focus on helping biohealth companies to secure non-dilutive funding.

Murphy is a recent graduate of the Masters of Biotechnology Program at Northwestern University. During her time at Northwestern, she gained professional experience in government affairs, project management, and corporate strategy at two life sciences companies. Prior to earning her graduate degree, she received her BS from the University of Nevada, Reno in neuroscience and chemistry.  

The Fischell Institute is working with University of Maryland (UMD) I-Corps representatives to plan a Medical Device I-Corps program, targeting dates in November. I-Corps is a National Science Foundation (NSF) program designed to foster, grow, and nurture innovation ecosystems regionally and nationally. UMD is the lead institution of the NSF I-Corps Hub: Mid-Atlantic Region and a member of the larger National Innovation Network.

UMD’s Introduction to I-Corps Course is a short, intense, bootcamp-style cohort. Participants work closely with teammates, other teams, and with mentors and instructors to develop business models around their innovations. Courses are approximately two weeks in duration, with the cohort meeting three or four times during the two-week span.

The newly minted public company has signed a lease for 60,000 square feet.

Image: 800 King Farm Blvd. will be converted from traditional office to lab space. BANYAN

Children's National Innovation Day features the hospital's life science and healthcare projects that are looking for strategic partnership, co-development, and licensing opportunities. The event will also showcase startup companies whose mission is aligned with our quest to bring novel pediatric products to patients and families.

ROCKVILLE, Md., July 29, 2022—The Montgomery County Council voted Tuesday to approve a new zoning measure introduced by Councilmember Andrew Friedson that will help attract and retain biohealth companies in Montgomery County and spur economic development, particularly in transit-oriented locations. The new zoning measure continues the Council’s ongoing efforts to support innovation and the biohealth sector, which is an essential part of Montgomery County’s economic engine.

NEW YORK, July 28, 2022 /PRNewswire/ -- The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, today announced the 2022 Prix Galien USA Award nominees for "Best Digital Health Solution," "Incubators, Accelerators and Equity," and "Prix Galien Startup." Winners will be announced during the Prix Galien USA Awards Ceremony on October 27, 2022, at the American Museum of Natural History in New York City.

"The Prix Galien Awards have become the most coveted prizes for those who dedicate their lives to the development of meaningful drugs and innovations," said Bernard Poussot, Director, Roche Holding, Former Chairman & CEO, Wyeth, Prix Galien Startup, Digital Health and Incubators, Accelerators and Equity Committee Chairman. "Members of the Awards Committees applaud the unwavering commitment of each nominee in their quest to provide a healthier future for the next generation."

Image: https://www.prnewswire.com

Financing led by SeedFolio, an early-stage high-tech biotech venture investment firm with participation from Ulu Ventures, Proxima VC, NuFund Venture group, Gaingels, Mana Ventures, and others.

WASHINGTON, D.C. (PRWEB) JULY 27, 2022

VerImmune, Inc. (“VerImmune”), a biotechnology company developing new therapeutic modalities that aim to redirect the body’s pre-existing immunity toward cancer, announced today the close of $2.5 million in Seed funding. The round was led by SeedFolio, a seed series venture capital firm focused on innovative, early-stage companies with game-changing impact potential. The round also included participation from US and global investment venture firms such as Ulu Ventures, and Proxima VC as well as leading private investment syndicate funds such as the NuFund Venture group (previously Tech Coast Angels- San Diego), Gaingels, Mana Ventures, and others.

The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region aims to be in the top three biohealth clusters in the country by 2023. Whether it’s Kite Pharma‘s new facility in Frederick County, MD, companies like ATCC scoring contracts for critical vaccines, or recent moves to the area by companies like Synexa Life Sciences, it’s evident that the BHCR is thriving.

Image: https://biobuzz.io

🌍Expand your company's reach to international markets with the University of Maryland - Robert H. Smith School of Business Global Consulting Program!

💡Develop your export capabilities and find new customers with a team of 3-5 business graduate students advised by top-rated Maryland Smith faculty, along with the Maryland Department of Commerce's Office of International Investment and Trade.

❗Applications close on Thursday, August 4. Learn more at: https://lnkd.in/eFfddjsA

-Top line data expected in second half of 2023-

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

ROCKVILLE, MD, UNITED STATES, July 19, 2022 /EINPresswire.com/ -- The biotech startup that brought to light the first and only PTSD genomic test announces continued research and innovation with continued funding from a second $100,000 matching grant awarded by the Maryland Industrial Partnership Program (MIPS).

In the Fall of 2020, Polaris Genomics was awarded a $100,000 matching grant by MIPS and began partnering with researchers at the University of Maryland Baltimore to test the performance of PTS-ID, a genomic blood test to identify persons with PTSD, measure disease severity and detect treatment response.

Omicron is mutating in giant leaps, with scientists racing to keep up. Its diversity is challenging vaccine efficacy and complicating treatment. But this fall, broad spectrum bivalent vaccines may help mitigate the seemingly never-ending spread of COVID-19.

Johns Hopkins virologist Andy Pekosz has been tracking coronavirus variants since the early days of the pandemic. He recently spoke to the Public Health On Call podcast about the range of omicron subvariants, omicron-specific vaccines, and what we can expect to see in the future from this "game-changer" variant.

The grant focuses on a few areas across four years, including addressing health disparities.

GERMANTOWN, Md., July 19, 2022 /PRNewswire/ -- Deka Biosciences announced today that it is breaking ground on a 14,000 square foot office and lab which will house a state of the art Research and Development, Process Development, and Manufacturing facility to further develop their novel cytokine therapies.  This will be the first facility to house a dual targeted cytokine development lab in the DC/Maryland/Virginia region and the only company in the US developing a therapeutic of its kind. The new headquarters will be located at 20380 Seneca Meadows Parkway in Germantown, Maryland and Deka anticipates the move to be completed in the first quarter of 2023.

On the heels of some big fundraising moves and in the hunt for a COVID-19 vaccine, Novavax is adding some Big Pharma experience to its executive team.

Joining the company's leadership team as chief medical officer is Filip Dubovsky, an AstraZeneca veteran. Dubovsky joins Novavax directly from the British drugmaker, where he served as head of clinical engagement and policy, plus as chief medical officer for clinical affairs. Before that role, he oversaw a portfolio of more than two dozen malaria vaccines at the PATH Malaria Vaccine Initiative.

Image: ovavax recruited two pharma and biotech veterans to senior posts. (Novavax)

GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has signed agreements with its partner, SK bioscience, for the manufacturing and supply of a version of the Novavax COVID-19 vaccine (NVX-CoV2373) containing Omicron variant and for the manufacture of the vaccine in prefilled syringes.

The companies signed an agreement for the technology transfer of Novavax' proprietary COVID-19 variant antigen materials so that SK bioscience can manufacture the drug substance targeting COVID-19 variants including the Omicron BA.5 subvariant.

Progress Labs at Progress Way in Gaithersburg, MD is a two-building approximately 495,000 SF development situated on 44 acres with I-270 visibility and access off of exit 11 Montgomery Village Avenue. Construction commenced at Progress Labs at 700 N. Frederick Avenue in Gaithersburg, MD back in October, and according to the video below (posted by Progress Labs on Monday, July 18th), is scheduled to be delivered in Q4 of 2022, which is ahead of schedule based on the schedule provided on its website, also seen below:

Building 1 Early TI Start: 11/2022

Building 2 Early TI Start: 2/2023

Building 1 Base Building Substantial Completion: 1/2023

Building 2 Base Building Substantial Completion: 4/2023

Click here to read more.

Maryland bucked a national trend in venture capital funding in the second quarter of 2022, recording an increase in the number of companies able to raise money even as the rest of the nation continued to struggle with the declining markets.

Nationally, VC deals decreased massively from $341.5 billion in the first quarter of 2022 to $144.2 billion in the second quarter. Maryland trended in the opposite direction seeing a massive increase in VC funding this quarter compared to the beginning of the year. In the first quarter, Maryland companies saw $325 million in funding, and in the second quarter that number more than doubled to $747.95 million.

Baltimore biotechnology startup Delfi Diagnostics has raised $225 million as it embarks on a 15,000-person trial for its early cancer detection technology.

The oversubscribed Series B round was the second mega-deal of the year in Greater Baltimore. DFJ Growth led the round, with participation from local Baltimore institutions such as T. Rowe Price Associates, Brown Advisory, PTX Capital and Rock Springs CapitalNational institutions such as Eli Lilly and Co., Point 72, Menlo Ventures and others also participated. The company previously raised $100 million in a Series A round in January 2021, and all of Delfi's previous investors also joined in the Series B round. Delfi began the fundraise in early 2022 and closed in July.

Image: Delfi Diagnostics, led by founder and CEO Victor Velculescu closed a $225 million series B round. Julien Capmeil

The contract from BARDA will advance development of an antibody cocktail therapeutic for the treatment of smallpox.

FREDERICK, MD. (PRWEB) JULY 15, 2022

BioFactura today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox.

This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the advanced development of its smallpox biodefense therapeutic. This contract option will provide an accelerated path for product development leading to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for first-in-human studies.

Altus Realty has acquired Research Square, two office buildings comprising 90,000 square feet in Rockville, Md., for $25.5 million.

Westat, an employee-owned research company headquartered in Rockville, was the seller of the two properties, located at 1500 and 1550 Research Boulevard.

SEE ALSO: Alan Mruvka On His E! Past and StorageBlue Future The Arlington, Va.-based Altus plans to turn the property into life sciences space, given that the buildings’ attributes make them amenable to such a conversion, according to CBRE, which represented the seller in the deal.

Westat decided to let go of the building as its workspace needs changed.

Image: RESEARCH SQUARE. PHOTO: CBRE

July 18, 2022, Baltimore, MD – Materic, a custom manufacturer of advanced materials, and LaunchPort, LLC, a medical device venture center and GMP contract manufacturing operation today announced a partnership to drive the use of advanced materials in the development of emerging medical device technologies.

GAITHERSBURG, Md., July 06, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Sujata Dayal as a Class II director to serve on the board effective July 15, 2022, with an initial term expiring at the 2023 annual meeting of stockholders. Ms. Dayal was also appointed as a member of both the Nominating and Corporate Governance Committee and the Special Committee on Manufacturing and Quality Oversight.

A new CBRE report ranked the top 25 life sciences research talent clusters for the first quarter.

Tustin, California, July 11, 2022 (GLOBE NEWSWIRE) — Canon Medical Systems USA Inc., a commercial subsidiary of Canon Medical Systems Corporation and a global leader in innovative diagnostic imaging technology, today announces it has signed a definitive agreement to acquire NXC Imaging, a medical imaging equipment distributor and service provider headquartered in Minneapolis, Minnesota. Founded in 1964, NXC Imaging’s distributorship area spans the U.S. Upper Midwest. The acquisition is expected to close in the third quarter of the 2022 calendar year.

• First IND for NexImmune’s AIM nanoparticle platform in solid tumors
• IND clearance enables commencement of a clinical trial to evaluate NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), in patients with relapsed or refractory human papillomavirus (HPV)-related cancers

GAITHERSBURG, Md., July 14, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, has received IND clearance for the Company’s first cellular therapy product candidate addressing solid tumors.  NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.

Kristi Jones, NexImmune’s CEO, commented, “The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our team’s continued focus and commitment to bringing novel therapies to patients with significant unmet need.  NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets.  The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.”

The announcement comes days after the Biden administration reached a deal to buy 3.2 million doses.

Image: Novavax has received emergency use authorization from the Food and Drug Administration for its two-dose Covid vaccine. MATTHEW FELDMAN

· Glioblastoma multiforme is one of the most complex, deadly and treatment-resistant cancer with a 5-year survival rate of 6.8% and an average length of survival of only 8 months *

· FDA ODD designation bolsters NeoImmuneTech's determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat cancer

ROCKVILLE, Md, July 13, 2022 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation for the treatment of Glioblastoma Multiforme.

Despite decades of research, GBM remains one of the deadliest and hardest-to-treat cancers. More than 13,000 Americans are expected to be diagnosed with GBM in 2022.1 Standard treatments using surgery, radiation, TMZ and TTFs have failed to date to greatly improve survival, and there is no standard treatment for recurrence, which is inevitable. Also, among the multiple factors impacting the survival of GBM patients, the current treatment options expose patients to a severe and prolonged systemic lymphopenic state known as "treatment-related lymphopenia" (TRL). TRL is associated with shorter survival both in GBM and other solid tumors. With its potential to restore lymphocyte levels and subsequently reverse systemic lymphopenia, NT-I7 may offer promising ways to effectively treat GBM, if confirmed by its development program.

Jul 11, 2022

Agreement will provide the first protein-based vaccine option in the U.S., pending FDA Emergency Use Authorization and CDC recommendation GAITHERSBURG, Md., July 11, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax' protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

"We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We are grateful for the U.S. government's ongoing support and partnership to bring Novavax' COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization."

LG Chem to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its T-cell therapy candidates for solid tumors

GAITHERSBURG, Md., July 12, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with LG Chem Ltd., a globally diversified chemical company established in petrochemical, advanced materials and bio-technology, aiming to create new value for its customers based on science.