Aug 15, 2022

• If authorized, Novavax' vaccine would be the first protein-based COVID-19 booster for adults
• If authorized, the Novavax COVID-19 Vaccine, Adjuvanted could be used as a booster dose for adults aged 18 and older vaccinated with any other currently available COVID-19 vaccine

GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.

Two new medical startups, focusing on addressing vision loss and catheter-associated urinary tract infections (UTIs), are on the horizon thanks to the $200,000 in grants the research teams received from the Johns Hopkins University’s Louis B. Thalheimer Fund for Translational Research.

14 researchers applied to the Thalheimer Fund, which was created to provide seed funding for proof-of-concept and validation studies of inventions coming out of Hopkins. The awards from the fund range from $25,000 to $100,000.

“We are excited to have received strong applications for disruptive technologies with commercialization potential that can have a future impact on human health and well-being,” Nicole Snell, associate director of ventures at Johns Hopkins Technology Ventures’ (JHTV) FastForward accelerator, which helps university-affiliated founders commercialize their technologies, said in a statement.

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VISION 2030: From Excellence to Preeminence

This summer, the University System of Maryland unveiled a new 10-year strategic plan—Vision 2030: From Excellence to Preeminence. The plan reflects 18 months of in-depth analysis. It coalesces intense discussions among dozens of groups of people with a stake in Maryland’s public universities—people with different opinions on higher education’s main objectives and different ideas on how to achieve them.

But one theme emerged across all groups: That students must serve as our starting point. They must set our agenda. They must center our work.

Click here to view the PDF

WALTHAM, Mass. and DUBLIN, Aug. 15, 2022 /PRNewswire/ -- Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.

ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

The world hasn’t seen commercial supersonic travel in nearly 20 years since the Concorde was retired in 2003, but all that is about to change with the development of a new, environmentally friendly airliner.

Meet Overture – the world’s fastest airliner that was developed by Denver-based Boom Supersonic.

Image: https://nypost.com

A quarter century after it began life as a garage start-up, Alexandria Real Estate Equities, Inc.’s (NYSE: ARE) decision to focus on the niche segment of life science real estate looks sounder than ever as demand for sophisticated lab space across major U.S. markets sits at an all-time high.

Pasadena, California-based Alexandria is the only publicly traded, pure-play office/laboratory REIT. The company, led by founder and Executive Chairman Joel Marcus, focuses exclusively on highly specialized lab space used for research and development in the booming life science industry.

Image: Lilly Institute for Genetic Medicine, 15 Necco Street, Seaport Innovation District, Greater Boston. Photo courtesy Alexandria Real Estate Equities, Inc.

UMBC will expand its work boosting diversity in academia from Maryland to the national level through a new NSF INCLUDES Alliance: Re-Imagining STEM Equity Utilizing Postdoc Pathways (RISE UPP). The RISE UPP Alliance, anticipated to officially launch in fall 2022, is modeled after the AGEP PROMISE Academy, a high-impact initiative co-led by UMBC that supports faculty diversification in the biomedical sciences across University System of Maryland (USM) institutions.

Image: Albin O. Kuhn Library (Marlayna Demond '11/UMBC)

It was a pleasure to welcome Congressman David Trone, Senator Ben Cardin, Senator Chris Van Hollen and National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership Director Laurie Locascio to our new facility in Frederick this week and to see Ellume’s #manufacturing capabilities first-hand.

Ellume's Frederick facility provides a sustainable U.S. domestic industrial base for #diagnostics production and stands ready to respond to any future surge in #COVID19 demand, while accelerating #innovation to develop solutions for future public health needs. A multimillion-dollar automation program is underway to further enhance the production capability of the facility.

Maryland is home to a number of STEM entrepreneurs with quality projects and the skills to succeed. What entrepreneurs often lack are the right connections and access to funding, which is especially true for women-led life sciences start-ups.

“In 2021, women founders raised just 2% of venture capital money and only 23% of biotech CEOs are women said Margia Argüello, formerly with the Maryland Department of Commerce’s Office of Life Sciences.

Image: The three busy female founders of innovative life science startups CarrTech, NasaClip and PerSoN Clinic took time to share what TEDCO’s Builder Fund and other TEDCO resources have meant to their companies.

The arc of the technology transfer profession can be tied to the Bayh-Dole Act of 1980 in the United States and similar enabling legislation from across the globe. This week  a new transformational law was passed – the CHIPS and Science Act – supporting U.S. semiconductor production and catalyzing research and development in many key technology areas and in new innovation regions of the country. Most importantly, this new law has a key provision titled “Planning and Capacity Building Awards” (Sec. 10391), which authorizes an unprecedented $3.1 billion to support technology transfer capacity building for research institutions.

Five months after the Australian-based biopharmaceutical company Ellume opened its first U.S. location in Frederick, the facility is scaling up its production of at-home COVID-19 tests by starting to automate the manufacturing process.

U.S. Rep. David Trone and U.S. Sens. Chris Van Hollen and Ben Cardin visited the sprawling campus along Executive Way on Tuesday afternoon for a tour of the company’s production capabilities and a town hall meeting with its employees.

Image: https://www.fredericknewspost.com - Staff photo by Ric Dugan

TENANT AMENITIES

• 8,867 RSF lab/office suite available 1Q23

• Dedicated suite entry

• Energy efficient HVAC

• Loading dock

• Ample parking

• Complimentary access to the Alexandria FitLab

fitness center (located at 910 Clopper Road)

• On-site asset management

• Proximate to major amenities, including

restaurants, retail, lodging, and banking

Click here for more information.

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. 

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.

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.

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)

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

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.

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

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.

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)

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 )

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.

• 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.