520th Edition, August 9, 2022

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August 9, 2022

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BARDA Director Gary L. Disbrow, Ph.D., Joins Rich Bendis on the BioTalk Podcast

Gary L. Disbrow, Ph.D., Director of the Biomedical Advanced Research and Development Authority (BARDA), visits BioTalk to discuss his career, advancing research, development, and collaboration in BioHealth.

Listen to the podcast now via Apple https://apple.co/3zCsbMl, Google https://bit.ly/3p2aAIP, Spotify https://spoti.fi/3p2V0Ne, and Amazon https://amzn.to/3BSQWqf.

BioBuzz: BioHealth Capital Region Forum Crab Trap Winners: Where Are They Now?

The BioHealth Capital Region Forum and Investment Conference are right around the corner on September 20th and 21st, 2022, respectively. And that means great networking opportunities, engaging panel discussions, valuable investor interaction and the celebrated and highly anticipated 7th annual Crab Trap competition.

The Crab Trap competition brings together entrepreneurs with innovative diagnostics, medical devices, therapeutics or other transformative health solutions to compete for a prize package valued at $50,000, which includes cash rewards and a one-year residency at JLABS @ Washington DC. Crab Trap finalists will earn the chance to make an in-person pitch at the BioHealth Region Investment Conference.

Johns Hopkins spinout Emocha Health closes $6.2M series A for video-based medication adherence

Emocha Health, a Johns Hopkins University spinout tackling medication adherence with an asynchronous video platform, has announced a $6.2 million series A round led by Claritas Health Ventures.

Like many other health technology startups recently, the company’s latest raise comes after months of pandemic-boosted growth. Emocha said in its announcement that revenue has increased 300% over the last year alone, due in part to the accelerated acceptance of virtual technologies in healthcare.

Image: Emocha Health has patients record videos of themselves taking a medication and asking questions about their treatment, which are then reviewed by a live team to ensure adherence and resolve any issues. CEO Sebastian Seiguer said it's a more effective approach than others that rely on financial incentives or prescription refill rates. (emocha Health)

Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma Member Discounts – Maryland Tech Council

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.

Emergent BioSolutions inks deal for smallpox newcomer Tembexa

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.

Emergent BioSolutions unveils 7th pandemic CDMO contract, this time for Humanigen's late-stage antibody hopeful | Fierce Pharma

Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions) (Emergent Biosolutions )

Jos Joore – MImetas CEO and BHI’s first International soft landing company

This interview is part of a series of conversations with the people working at Mimetas. The 'I' in Mimetas focuses on the personal side of the scientists that drive our world. Today we have a chat with Jos Joore, CEO and co-founder of Mimetas.

What small things in life make you happy?

That's an interesting one. I would say it's, in particular, the small things that make me happy. Being out in nature, taking a run, being with family. People need a firm, happy basis to cope with challenges like setting up and running a company. That basis is made up of all the small things in life that are, in fact, the most important.

What does #USPVerified mean?

What does #USPVerified mean? It means that you can trust that what's on the label is what's in the bottle. The USP Verified Mark has appeared on more than 880 million bottle labels, making quality visible so you can choose dietary supplements with confidence. Learn more about USP Verified products at quality-supplements.org #NoDoubtAboutIt

IPO market in a ‘wait-and-see period,’ EY Americas IPO leader says

EY Americas IPO Leader Rachel Gerring joins Yahoo Finance Live to discuss the U.S. IPO market, navigating through recessionary fears, inflation, supply chain woes, volatility, and the outlook for IPOs.

Video Transcript BRIAN SOZZI: Companies are pumping the brakes on public debuts with the number of IPOs in the US plunging by 75% in the first half of this year compared to last year according to new data from EY. Joining us now to break down the latest in the IPO space is EY Americas IPO leader Rachel Gerring. Rachel, good to see you here this morning. Have we reached a bottom yet?

Image: From Video

U.S. Department of Commerce Announces Winners of American Rescue Plan $500 Million Good Jobs Challenge to Expand Employment Opportunities | U.S. Economic Development Administration

WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced grant awards to 32 industry-led workforce training partnerships across the country as part of the $500 million Good Jobs Challenge funded by President Biden’s American Rescue Plan. The Good Jobs Challenge is administered by the Commerce Department’s Economic Development Administration and will enable communities across the country to invest in innovative approaches to workforce development that will secure job opportunities for more than 50,000 Americans.

“BioTalk with Rich Bendis” Podcast Featured in BioBuzz Podcasts to Follow Now

In a job market that’s become increasingly competitive and employer-driven, it’s imperative for both active and passive job candidates to do their homework. Understanding national biotech market trends and how those forces are impacting regional biohubs and the market at large could be a key differentiator between job seekers.

If you’re a job seeker in the BioHealth Capital Region (BHCR) or Greater Philadelphia, there are a host of valuable resources for job market research that can help target your search. The weekly BioBuzz Newsletter and Job Board, BioHealth Innovation’s newsletter, the Maryland Tech Council’s Biohub Maryland Pathways website, and Big4Bio are all just a few of the great sources of information and job opportunities.

Add to that LinkedIn and local in-person networking events, and there are many ways for job seekers to educate themselves on market conditions, specific job qualifications, and where one might fit within the overall talent market.

REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

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."

NIH Applicant Assistance Program Accepting Applications

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.

GSK enters agreement with 12 EU countries – BioProcess InsiderBioProcess International

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).

Biotech & Beer -NOVA – Registration

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!

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