KaliVir Declares US FDA Nods IND Application To Perform Phase Study

KaliVir Immunotherapeutics, Inc., a biotechnology company developing cutting-edge, multi-mechanism oncolytic virus immunotherapy programs, announced that it has received a Phase 1 investigational new drug (IND) application from the US Food and Drug Administration (FDA). In a clinical trial. A study of ASP1012 in participants with locally advanced or metastatic solid tumors.Discovered and developed by Kalivir and acquired by Astellas Pharma Inc. in December 2020. Approved ASP1012 (formerly VET2-L2) is a systemic oncolytic vaccinia virus therapy that delivers the virus intravenously and expresses the Leptin-IL2 fusion protein as a therapeutic payload. The trial is expected to begin in the first quarter of 2024, as per Pharmabiz."ASP1012 was the first candidate built on our unique Vaccinia Enhanced Template (VET) platform, and we are excited to reach this important milestone," said Kalivir's Chief Scientific Officer and Founder, Ph.D. Steve Thorne. "Our partnership with Astellas underscores our mission to bring critical cancer treatments to patients, and we look forward to our continued collaboration.""Immuno-oncology is at the core of Astella's RandD strategy, and the enrichment of our pipeline with the ASP1012 oncolytic virus demonstrates our commitment to providing new opportunities to treat cancers where there are no effective treatment options ," he said. MD Peter Sandor MBA, Vice President and General Manager, Immuno-Oncology, Astellas. "The combination of KaliVir's oncolytic virus expertise and Astellas' drug development capabilities has been an excellent partnership, and it is exciting to see the collaboration progress in this way, bringing us one step closer to developing immuno-oncology therapies for patients."KaliVir Immunotherapeutics is a privately held biotechnology company developing cutting-edge, multi-mechanism oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform, the Vaccinia Enhanced Template "VET" platform, which can generate new potent oncolytic vaccinia viruses with modifications to maximize virus replication and improve intravenous delivery and dissemination.