KaliVir announces US FDA clears IND application to initiate phase 1 study of ASP1012 to treat locally advanced or metastatic solid tumours

KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programmes, announced clearance of an Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to initiate a phase 1 clinical study of ASP1012 in participants with locally advanced or metastatic solid tumours.

Discovered and developed by Kalivir and licensed to Astellas Pharma Inc. in December 2020, ASP1012 (formerly named VET2-L2) is a systemic oncolytic vaccinia virus therapy in which the virus is delivered intravenously and expresses Leptin-IL2 fusion protein as a therapeutic payload. The trial is expected to begin in Q1 2024.

“ASP1012 was the first candidate built from our unique Vaccinia Enhanced Template (VET) platform and we are thrilled to reach this important milestone,” said Steve Thorne, Ph.D, chief scientific officer and founder of Kalivir. “Our partnership with Astellas underscores our mission to bring critical cancer therapies to patients and we look forward to continued collaborations.”

“Immuno-oncology is a core focus of the Astellas R&D strategy and enriching our pipeline with the oncolytic virus ASP1012 is a testament to our commitment to provide new options to treat cancers where there are no effective treatment options,” said Peter Sandor, M.D., MBA, senior vice president and primary focus lead, immuno-oncology, Astellas. “The combination of KaliVir’s expertise in oncolytic viruses and Astellas’ drug development capabilities has been a great partnership and it’s exciting to see the collaboration move forward in this way, bringing us one step closer to developing an immuno-oncology therapy for patients.”

KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programmes. The company has developed a unique vaccinia virus-based platform, Vaccinia Enhanced Template “VET” Platform, that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread.

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