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MoCo Life Sci2

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

By News

MoCo Life Sci2The 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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Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study

By News

Precigen LogoPrecigen 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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Tedcopath250

TEDCO Announces Investment into Pathotrak

By News

Tedcopath250COLUMBIA, 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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Claire2

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

By News

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

Claire2ROCKVILLE, 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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MSCRF Black Transparent

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

By News

MSCRF Black TransparentWhat 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

Emergent250

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

By News

Emergent250On 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.

ABL250

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

By News

ABL250Rockville, 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

By News

HeMemics LogoGAITHERSBURG, 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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APT250

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

By News

APT250 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

By News

RGNX LogoROCKVILLE, 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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