BioHealth Innovation Weekly for May 29, 2024

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May 29, 2024

Celebrating Excellence: Maryland Tech Council 2024 ICON Award Winners

BioHealth Innovation Inc. (BHI) congratulates the outstanding winners of the 2024 ICON Awards announced by the Maryland Tech Council. These awards recognize the incredible contributions of individuals and companies in the fields of technology and life sciences, highlighting their impact on millions of lives.

AstraZeneca: with a member of our BHI Board of Directors, Tyrell Rivers, Ph.D., has been honored as the Life Science Company of the Year. Their continued dedication to advancing healthcare through groundbreaking research and development is truly commendable.

Nanochon: We are particularly proud of Nanochon and Benjamin Holmes, the recipients of the Chief Executive Officer of the Year—Life Sciences award. Nanochon is a previous winner of our BioHealth Capital Region Crab Trap, and it’s exciting to see their sustained excellence and innovation being recognized on a larger stage.

Solaxa: A special congratulations to Solaxa, who was awarded the Venture Mentoring Services Venture of the Year. We are pleased to note that two members of Solaxa's leadership team, Luis T. Gutierrez, Jr. and Jennifer Butler, are part of the BHI/Montgomery County Executive-In-Residence Program. This recognition underscores their remarkable leadership and commitment to advancing technology and life sciences.

Rockville's Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.

Supernus Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in Epilepsy

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as finding effective doses in various treatment-resistant seizure types. The interim analysis is as of May 1, 2024, and is based on 41 enrolled subjects, of which 19 completed the maintenance period. Of these 19 subjects, 16 subjects had focal seizures.

Activation Capital Introduces 'Frontier BioHealth' to Catalyze Life Science Startups

RICHMOND, Va., May 23, 2024 /PRNewswire/ -- Activation Capital announces the launch of Frontier BioHealth, an educational and support program designed to provide highly specialized training, targeted mentorship, and relationship building to help scale pharmaceutical, biotech, medical device, and health-focused consumer products companies. The inaugural four-month program will be critical in bringing research-intense products and companies to market. It will broaden the continuum of regional early-stage support – additive to Virginia Commonwealth University's proof of concept fund and newly launched pre-accelerator program – and continue to coalesce the emerging private investment ecosystem in Central Virginia.

PQE Group US Earns Great Place to Work Certification™

Rockville, MD, May 22, 2024. PQE Group is proud to announce that, for the third consecutive year, its US subsidiary has been Certified™ by Great Place To Work®. This prestigious award is based entirely on what current employees say about their experience working at PQE Group US. This year, 85% of employees in the US said it’s a great place to work, 28% higher than the average U.S. company.

Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. To obtain this recognition, PQE Group’s US employees completed a voluntary survey, responding to numerous questions regarding their satisfaction in a wide array of areas that encompass the framework of PQE Group’s company culture.

Frederick's Theradaptive Secures $1M in Funding from Maryland Stem Cell Research Fund for Human Clinical Trials

FREDERICK, Md., May 22, 2024 /PRNewswire/ -- Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP. OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.

Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis

GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”).

Descartes-08, the Company’s lead product candidate, is an autologous mRNA CAR-T directed against the B cell maturation antigen (“BCMA”) initially being developed for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue.

MaxCyte Signs Strategic Platform License Agreement with Legend Biotech to Accelerate Cell Therapy Discovery and Development

Legend Biotech obtains license to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support its non-viral engineered pipeline portfolio across a variety of cell types including T cells, Gamma-Delta T cells and NK Cells.

ROCKVILLE, Md., May 22, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development, and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced it has entered into a strategic platform license (SPL) agreement with Legend Biotech, a global leader in cell therapy.

Nona Biosciences Announces Global License and Option Agreement with AstraZeneca for Monoclonal Antibody to be Developed into Novel Tumor Targeted Therapies

Nona Biosciences, a global biotechnology company providing a total solution from “Idea to IND” (I to ITM), ranging from target validation and antibody discovery through preclinical research, announced today that it has entered into a license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology.

Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction. Nona is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona is eligible to receive payments for the option programs should AstraZeneca exercise these options.

Welldoc Certified as a Great Place to Work® for Third Year in a Row

COLUMBIA, Md., May 21, 2024 — Welldoc^®, a leading digital health company specializing in AI-driven cardiometabolic health, announced today that it was Certified™ by Great Place to Work® for the third consecutive year. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 90 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 31 points.

Great Place to Work is the global authority on workplace culture, known for its expertise in employee experience and leadership practices that drive business success. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.