FDA approves KaliVir Immunotherapeutics drug

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The U.S. Food and Drug Administration (FDA) recently approved the Investigational New Drug application for VET3-TGI, a drug developed by Pittsburgh-based KaliVir Immunotherapeutics for patients with incurable, advanced solid tumors.

“The initiation of this phase 1/1b clinical study marks a pivotal moment in our continued journey to redefine cancer treatment with oncolytic virus therapy and combat advanced, unresectable or metastatic solid tumors,” Dr. Helena Chaye, KaliVir Immunotherapeutics CEO, said. “This marks our second initiation of a clinical trial from the VET platform, having announced in 2023 the progress with ASP1012 exclusively licensed to Astellas. We remain fully committed to pushing the boundaries on what is possible with cancer therapies and develop safer, more effective options that have the potential to transform the treatment landscape of oncology.”

In nonclinical studies, VET3-TGI targeted and killed tumor cells while stimulating anti-cancer immunity.

During the phase 1/1b study, researchers will evaluate the safety profile and efficacy of VET3-TGI in patients with advanced, incurable solid tumors when administered through intravenous infusion or intratumoral injection.

The study also will assess VET3-TGI as a monotherapy and in combination with checkpoint inhibitor therapy.

KaliVir Immunotherapeutics is a biotech company developing multimechanistic oncolytic viral immunotherapy programs to treat cancer patients with multiple tumor types.