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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. 

 

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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.

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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.

 

Cursor and Johns Hopkins spinout Emocha Health closes 6 2M series A for video based medication adherence Fierce Healthcare

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)

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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

 

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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.

 

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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?

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Cursor and 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.

 

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)

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)

Cursor and 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 )

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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 BoardBioHealth 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.

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  • 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."

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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.

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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.

 

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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).

 

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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

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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.  

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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.

 

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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.

 

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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.

 

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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

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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.

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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.

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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.

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🌍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

 

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-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.

Polaris Genomics Announces Continued Research 100K Grant Awarded from Maryland Industrial Partnership Program MIPS EIN Presswire

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.

 

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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.

 

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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.

Novavax advancing COVID 19 shot recruits AstraZeneca exec as its chief medical officer Fierce Pharma

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)

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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.

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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.

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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.

 

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

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