BioHealth Innovation Weekly for June 18, 2024

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June 18, 2024

Leading the Charge in Tech-Based Economic Development: A Conversation with Dan Berglund of SSTI on BioTalk

Join us for an enlightening episode of BioTalk with Rich Bendis as we welcome Dan Berglund, President and CEO of SSTI. With nearly four decades of experience in tech-based economic development (TBED), Dan has been a pivotal figure in shaping the landscape of innovation and entrepreneurship across the nation.

In this episode, Dan shares the history and evolution of Technology Based Economic Development, discussing key initiatives in states like Ohio and Pennsylvania, and at the federal level. He highlights the importance of partnerships, detailing a compendium of state and federal cooperative technology programs that have driven progress in the field.

We explore the early years of SSTI, looking into its creation, mission, and initial goals, and how it has grown to support a nationwide network dedicated to fostering tech-based economies. Dan discusses the evolution and growth of state TBED programs, and the changing role of the federal government in supporting these initiatives through agencies like STCS, OSTP, Commerce, NIST, and EDA.

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Dan also emphasizes the importance of private/public TBED partnerships, sharing insights into how these collaborations have bolstered economic growth and innovation. As he prepares to step down from his role after 28 years,and assume a part time role, Dan discusses the recruitment of a new CEO and reflects on SSTI's achievements, his legacy, and his vision for the organization's future.

Additionally, Dan talks about Rich Bendis’s role as an original founding board member of SSTI, and his significant help in the early development of the organization. He also highlights the presence of several SSTI members in the BioHealth Capital Region.

Unlock Your Innovation Potential with BioHealth Innovation's Grant Mapping Services

Navigating the complex landscape of non-dilutive funding can be daunting for many innovators and researchers. Identifying suitable grants that align with specific project goals is often challenging, requiring a deep understanding of the funding landscape and specific program criteria.

We recognize these challenges at BioHealth Innovation (BHI) and are committed to supporting your journey. Our comprehensive grant mapping services are designed to pinpoint the most relevant funding opportunities tailored to your unique needs. With our expert guidance, you can confidently navigate the intricate world of grants, ensuring that your projects receive the support they deserve.

In addition to our grant mapping services, BHI offers dedicated SBIR/STTR grant writing assistance. Our team of seasoned professionals will work closely with you to craft compelling grant proposals that stand out to funding agencies. We understand the nuances and expectations of these programs, which significantly enhances your chances of success.

Partner with BHI to leverage our expertise and maximize your chances of securing the right non-dilutive funding for your innovative projects. With our support, you can focus on what you do best—innovating and pushing the boundaries of biohealth and life sciences

Let BHI be your trusted partner in navigating the funding landscape and unlocking the full potential of your groundbreaking work. If you're seeking assistance, don't hesitate to reach out toJon NelsonatJNelson@BioHealthInnovation.org.

Seraxis Wins Maryland Stem Cell Research Fund Grant to Accelerate Development of Allogenetically Compatible Pancreatic Islet Replacement Therapy for Functional Cure of T1D

GERMANTOWN, MD / ACCESSWIRE / June 14, 2024 / Seraxis, Inc., a regenerative medicine company developing pancreatic islet replacement therapies to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, has been notified that the company is the awardee of a $400,000 Commercialization Program grant from the Maryland Stem Cell Research Fund (MSCRF) that aims to foster Maryland research to enhance and propel stem cell treatments. Seraxis will use the MSCRF grant to accelerate the validation and manufacturing of Seraxis' genetically modified pancreatic cell line (SR-03) that is designed to be a universal allogenic transplant that will not require lifelong anti-rejection immune suppression.

Vanda Pharmaceuticals Confirms Receipt of Revised Unsolicited Takeover Proposal from Future Pak

WASHINGTON, June 13, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("FP") to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda's Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

TEDCO’s Maryland Innovation Initiative Announces Kulshreshtha as the New Executive Director

COLUMBIA, Md., (June 13, 2024) — The Maryland Innovation Initiative (MII) Board of Directors announces the appointment of Abishek Kulshreshtha as the executive director of TEDCO’s MII program. In this position, Kulshreshtha will oversee all MII activities starting July 1, 2024.

As an independent unit within TEDCO, the Maryland Technology Development Corporation, MII was created to promote the commercialization of research conducted in five of Maryland’s academic research institutions (Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park) while leveraging each institution’s strengths. This collaborative program has supported more than 170 startup companies, created 370 jobs and procured more than $737 million in follow-on funding since its inception nearly 12 years ago.

Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property

BETHESDA, Md., June 17, 2024 /PRNewswire/ -- Northwest Biotherapeutics, Inc. (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax^® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.

The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

Novavax Submits Application to U.S. FDA for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

GAITHERSBURG, Md., June 14, 2024/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.^1-3

Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.

Ascentage Pharma Signs Option Agreement with Takeda to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

ROCKVILLE, Md. and SUZHOU, China, June 14, 2024 /PRNewswire/ -- Ascentage Pharma (6855 HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today the signing of an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of among others, mainland China, Hong Kong, Macau, Taiwan, China.

Despite the impact TKIs have had in the treatment of patients with CML, there remains a significant unmet need for patients whose disease is resistant to these therapies or who develop hard-to-treat mutations following these treatments.

REGENXBIO Announces Leadership Transition

ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as REGENXBIO's Lead Independent Director, a role previously held by Jerry Karabelas, Ph.D. Dr. Karabelas and Co-Founder Allan Fox, who has served as Chairman since 2020, will remain on the Board.

TEDCO Invests in Kubanda Cryotherapy

Biotechnology company innovates treatment for pets with lumps, bumps and cancer

COLUMBIA, Md., (June 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Pre-Seed Builder Fund investment in Kubanda Cryotherapy. The Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds, which were created to engage and invest in economically underserved founders and communities.

“Most pet tumors go untreated, and existing treatment options are inaccessible due to high costs and slow healing times,” said Bailey Surtees, CEO of Kubanda Cryotherapy. “We saw this gap in care and built an alternative, non-surgical solution, which offers less down time and better healing outcomes for pets. With TEDCO’s support, we can continue our mission of breaking down barriers to high-quality care.”

KeViRx, Inc. Awarded $1.99 Million to Advance Small Molecule Technology for Acute Lung Injury

CHARLOTTESVILLE, VA / ACCESSWIRE / June 11, 2024 / KeViRx, Inc., an innovative, early-stage pharmaceutical company, announced today the receipt of $1.99 million in grant funding from the U.S. Department of Defense's Peer Reviewed Medical Research Program. This grant funding will allow KeViRx to advance its first-in-class small molecule platform technology, KVX-053, toward IND for pulmonary microvascular leakage and inflammation during acute lung injury (ALI). In the U.S., ALI affects 200,000 patients every year and can result from viral infection, sepsis, pneumonia or inhalation of chemical toxins. The most severe form of ALI is referred to as acute respiratory distress syndrome or ARDS.

"There are very limited treatment options for patients with ALI and 40% will die of ARDS," KeViRx Co-founder John S. Lazo said. "KVX-053 is a host-directed, insult-agnostic small molecule that targets the central pathways that are dysfunctional in ARDS. If we are successful, KVX-053 would be transformative for this disease."