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First small molecule allosteric binder discovered with Gain’s computational drug discovery platform enters clinical development

BETHESDA, Md., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced dosing of the first two subjects in a Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease. The Company expects to complete this trial in the first half of 2024.

“Initiating first-in-human dosing with GT-02287 is an important milestone for Gain as we enter a new era as a clinical-stage company,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “I am very proud of the work accomplished by the entire Gain team to get us to this stage today, and we are eager to advance our understanding of the safety, tolerability and effect of GT-02287 in humans. This represents another major step forward toward providing a treatment for Parkinson’s patients and their families impacted by this devastating disease.”

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GAITHERSBURG, Md.Oct. 3, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax's vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians' offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

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ROCKVILLE, Md., Oct. 3, 2023 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Matt Bond has become its chief financial officer (CFO).

Emmes Chief Executive Officer Peter Ronco said, "Matt combines a rich set of CFO experiences with a deep understanding of the biopharma and clinical technology solutions space. A seasoned executive with over 30 years of financial leadership experience, he has led the finance function for many successful, private-equity-backed companies in the pharmaceutical services and contract research market segment."

"This is a perfect time to join the company, as we continue to build our reputation with government and biopharma clients and ramp up our presence in new global markets," noted Bond. "I'm able to hit the ground running, because I've worked in this sector for decades and have been successful in generating profitable growth while partnering with great management teams."

Before joining Emmes, Bond was the CFO of Bracket (now Signant Health), a leading technology provider to the drug development market.  There, he led the organization through a period of sustained  growth, including a successful sale of the company to another global, private-equity-backed firm.  Before that, he was a founder and served as CFO of Aptiv Solutions,  a technology-focused CRO. Bond was part of the leadership team that grew the business from a startup to a large multinational organization through the acquisition of more than 10 companies. 

Previously, Bond was executive vice president and CFO of PRA, a global CRO, where he led a successful initial public offering. Earlier in his career, Matt was vice president of finance with Marriott International and a consultant with a leading, global financial consulting firm. He holds a B.S. degree from Wake Forest University.

Ronco said, "We are pleased to have Matt join our team. His hands-on experience with mergers and acquisitions will be a great help as we continue to identify, review and assimilate companies that complement our strengths and accelerate our global growth."

About Emmes

Founded more than 45 years ago, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company's clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

 

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Maryland has renewed its Memorandum of Understanding (MOU) with the Korea SMEs and Startups Agency, also known as KOSME.

As part of the MOU signed in 2021, Maryland and KOSME support Korean startups and small and medium-sized businesses interested in entering green and high-tech sectors in the U.S., with the potential for them to participate in Maryland’s Global Gateway program. The partnership also supports companies interested in the aerospace, biohealth, cybersecurity, and renewable energy industries.

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The BioHealth Capital Region recently played host to a series of significant events that drew attention from the global biopharma community. Notably, several Israeli BioHealth companies, some traveling directly from Israel, participated in these events, underscoring the region's growing prominence, especially after being recognized by GEN as a Top 3 BioPharma Cluster in the United States. This remarkable participation was made possible with the dedicated efforts of Aisha Espey, Director of Commerce, Head of Science and Technology from the Embassy of Israel in Washington DC, and Andrea Yonah, Director of Business Development for the U.S. East Coast/Midwest at the U.S. Israel Binational Industrial R&D (BIRD) Foundation.

The BioHealth Capital Region Forum serves as the region's premier gathering for the biopharma sector, fostering collaborations and discussions that advance public health and economic outcomes. The Crab Trap, now in its 8th year, is a competition spotlighting entrepreneurs with transformative health solutions. The Investment Conference is a platform for companies and investors to create partnerships, featuring brief presentations highlighting BioHealth opportunities and innovations.

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Innara Health has extended their recognition to BioHealth Innovation, Inc. (BHI) and Ethel Rubin for our significant contributions to Innara Health's journey. BHI is acknowledged for our confidence and insight in introducing Innara Health to the BioHealth Capital Region, while Ethel Rubin is thanked for her expert counsel, candor, and influential role on the Board, along with her valuable network. Our support has played a crucial part in Innara Health's mission to improve the lives of premature newborns and infants.

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FREDERICK, Md.Oct. 2, 2023 /PRNewswire-PRWeb/ -- BioFactura, Inc. today announced a contract option activation of over $16 million by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as part of its prime contract valued at over $77 million for the advanced development of its Smallpox Biodefense Therapeutic. This option will continue to support ongoing product development to include clinical manufacturing of the therapeutic for an upcoming first-in-human Phase 1 trial, which may be funded in a future contract option.

BioFactura's monoclonal antibody-based product has the potential to fulfill an unmet need in preparedness, augment current medical countermeasures and guard against potential resistance. While smallpox was declared eradicated in 1980 by the World Health Organization after an extensive vaccination campaign, the threat of bioterrorism and/or inadvertent release persists.

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How can patients help shape the future of scientific innovation? What's the vital role of the patient's voice in developing life-changing medicines? In this captivating episode, fresh off her thought-provoking appearance at the 9th Annual BioHealth Capital Region Forum, Dr. Theresa Podrebarac takes us on a journey through the dynamic landscape of autoimmune medicine.

Dr. Podrebarac is a renowned physician scientist with a wealth of expertise in the biotech industry. As the Senior Vice President of Clinical Development at Horizon Therapeutics, she's at the forefront of bringing hope to patients with rare, autoimmune, and severe inflammatory diseases. Join us as we explore pivotal questions:

  • What is Horizon Therapeutics' mission, and what are Dr. Podrebarac's primary responsibilities in this quest for life-changing medicines?
  • How has Dr. Podrebarac's background as a rheumatologist influenced her belief in the importance of the patient's perspective in drug development?
  • Discover Horizon's impressive journey in clinical development, with a sharp focus on autoimmune diseases.
  • Dive into Horizon's global presence and the crucial role of its Maryland operations.
  • What are the clinical goals that will shape the future of autoimmune medicine?

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The Greater Washington area has a long history of influential business leaders powering the growth of our region and the strength of their communities. On Dec. 5, the Washington Business Hall of Fame will welcome five such leaders to receive our region’s signature lifetime business achievement award. The Hall of Fame brings these visionaries (the best in business) to the table with the next generation of leaders (the next in business), through an experience that connects and inspires us all.

The 2023 Hall of Fame Laureates are no strangers to media coverage. If you live in the Washington region, chances are you’ve seen their names in headlines for years. What you may not have witnessed is these trailblazers telling their stories in their own words. That’s what this series brings you – the look back, lessons and life advice that these Laureates have to offer based on a lifetime of success.

 

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COLUMBIA, Md. (September 28, 2023) –TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment into AGED Diagnostics, a biotechnology company. Previously, AGED Diagnostics received a $250,000 investment from TEDCO’s Builder Fund, a funding opportunity that is under the umbrella of our Social Impact Funds.

“1 in 3 Americans have liver disease, but many remain unaware of it until the disease progresses to a stage when it is no longer curable, patient outcomes are poor and/or healthcare costs are burdensome,” said Rachel Zayas, CEO of AGED Diagnostics. “Thanks to TEDCO’s investment we are able to continue our research and development, working towards a future where liver disease can have early detection.”

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GERMANTOWN, Md.Sept. 28, 2023 /PRNewswire/ -- Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka's pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK210 (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board.

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The latest rankings from Genetic Engineering & Biotechnology News  (or GEN) included some long-awaited good news for Maryland: the Biohealth Capital Region (BHCR) had moved up to No. 3 on the publication’s list of the top ten biopharma clusters in the United States.

Leaders in Maryland’s biohealth industry have been working to make the BHCR a “Top 3 by 2023” since back in 2016. In recent years, the region (comprising Maryland, Virginia and Washington, D.C.) has ranked No. 4.

“It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal,” Rich Bendis, president and CEO of BioHealth Innovation, Inc., said in a statement . “The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

Click here to read the entire article.

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The latest upgrade is part of wider goals to create the industry's first unified digital data platform for decentralized and hybrid trials

ROCKVILLE, Md.Sept. 27, 2023 /PRNewswire/ -- Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical. The new application means any scheduled visit can become virtual with video calls augmented directly through the platform and patients signing in through their existing participant portal. Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.

RaiseYourReach

If your Maryland-based life sciences company is doing R&D in biotechnology and preparing to raise equity funding, your investors may be eligible to benefit from tax credits from the State of Maryland through the Biotechnology Investment Incentive Tax Credit (BIITC) program. Join the Maryland Department of Commerce on October 2nd to learn about the program benefits and how you can work with your investors to enhance their returns by investing in you. 

Click here to learn more and register.

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Fund III cohort accelerates the energy transition, facilitates discovery of better therapeutics and advances critical industries

ATLANTA & BOSTON & SAN DIEGO & TAMPA, Fla. & WASHINGTON–()–Anzu Partners, an investment firm delivering capital and strategic support to early-stage breakthrough technology companies, today announced it has raised more than $200 million at the close of its third venture capital fund.

Fund III was established to invest in companies developing next-generation solutions in clean technology, industrial innovations, and life sciences. Investors in Fund III include new and returning public and private institutions, single and multifamily offices, and accredited investors across the U.S. and overseas.