Pharma Focus America

KaliVir Immunotherapeutics Announces FDA Approval for IND Application of Oncolytic Immunotherapy VET3-TGI for Solid Tumors

Tuesday, July 02, 2024

KaliVir Immunotherapeutics, Inc., a biotech company specializing in advanced oncolytic viral immunotherapy, has announced that the FDA has approved the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with advanced, incurable solid tumors.

VET3-TGI is a pioneering oncolytic immunotherapy designed to selectively target and destroy tumor cells while enhancing anti-cancer immunity through its therapeutic payload, which includes transgenes for interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b study ( ID NCT06444815) will investigate the safety and efficacy of VET3-TGI when administered via intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors. This trial will examine VET3-TGI both as a standalone treatment and in combination with checkpoint inhibitor therapy.

"The start of this Phase 1/1b clinical trial represents a significant milestone in our mission to transform cancer treatment with oncolytic virus therapy, addressing advanced, unresectable, or metastatic solid tumors," stated Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. "This is our second clinical trial launch from the VET platform, following the 2023 progress with ASP1012, which is exclusively licensed to Astellas. We are dedicated to advancing the field of cancer therapies and developing safer, more effective treatment options that could revolutionize oncology care."



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