Vironexis Biotherapeutics Launches with FDA Clearance for First AAV-Delivered Cancer Immunotherapy Trial

SAN DIEGO, Calif., September 12, 2024 – Vironexis Biotherapeutics has launched from stealth, announcing FDA clearance of its IND application for VNX-101, a gene therapy targeting CD19+ acute lymphoblastic leukemia. This marks the first-ever clinical trial of an AAV-delivered cancer immunotherapy, expected to begin in Q4 2024.

Vironexis’s TransJoin™ platform aims to improve cancer treatments through safer, single-dose, off-the-shelf gene therapies that target cancer cells continuously. The company has built a pipeline of over ten candidates, including therapies for blood cancers, solid tumor metastasis prevention, and a cancer vaccine.

“Our technology leverages AAV to enhance the safety, efficacy, and durability of T-cell immunotherapies, potentially overcoming limitations of current treatments,” said CEO Samit Varma.

The $26 million seed financing, led by Drive Capital and Future Ventures, will support Vironexis’s plans to advance its lead programs into clinical trials by 2025. Founded on research from Nationwide Children’s Hospital, Vironexis’s approach uses AAV vectors to deliver engineered transgenes that enable continuous T-cell targeting of tumors.

About Vironexis Biotherapeutics

Vironexis Biotherapeutics is pioneering AAV-delivered T-cell immunotherapy to transform cancer treatment. The TransJoin™ platform offers off-the-shelf, single-dose therapies designed to improve current immunotherapy challenges. 

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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