KaliVir Immunotherapeutics Gets FDA Clearance for Oncolytic Immunotherapy VET3-TGI

KaliVir Immunotherapeutics, Inc., a biotechnology company specializing in advanced oncolytic viral immunotherapy, has announced that the United States Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for the STEALTH-001 study. This study will investigate the therapeutic potential of VET3-TGI in patients suffering from advanced, incurable solid tumors.

VET3-TGI represents an innovative approach in oncolytic immunotherapy. Preclinical studies have demonstrated that VET3-TGI selectively targets and eradicates tumor cells while simultaneously enhancing anti-cancer immune responses. This dual-action is achieved through the expression of interleukin-12 and a TGFbeta inhibitor, both of which are integral components of VET3-TGI's therapeutic payload.

The Phase 1/1b clinical trial, registered under ClinicalTrials.gov ID NCT06444815, aims to evaluate the safety and efficacy of VET3-TGI in patients with advanced solid tumors. The study will examine the effects of VET3-TGI when administered via intravenous infusion or intratumoral injection. It will also explore the therapy's potential both as a standalone treatment and in combination with established checkpoint inhibitor therapies.

“This milestone is significant in our ongoing mission to revolutionize cancer treatment through oncolytic virus therapy, particularly for advanced, inoperable, or metastatic solid tumors,” stated Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. She highlighted that this trial marks the second clinical endeavor derived from the VET platform, following the progress of ASP1012, which is licensed exclusively to Astellas. Chaye reiterated the company's dedication to developing innovative cancer therapies that aim to transform the oncology treatment landscape.

KaliVir Immunotherapeutics, Inc. is a privately owned biotech company that focuses on the development of sophisticated, multi-mechanistic oncolytic viral immunotherapies. The company's proprietary Vaccinia Enhanced Template (VET) Platform is designed to produce highly effective oncolytic vaccinia viruses. These viruses are engineered to optimize viral replication and enhance systemic delivery and dispersion. The platform leverages the vaccinia virus's large transgene capacity to administer therapeutics tailored to specific tumor immunophenotypes, thereby stimulating the patient's immune system and altering the tumor microenvironment.

KaliVir's portfolio of oncolytic virus candidates is developed to be safe, effective, and systemically deliverable, targeting a broad range of cancer types. The company has established partnerships with Roche and Astellas Pharma to design and develop new oncolytic vaccinia viruses based on the VET Platform. Notably, Astellas holds a global exclusive license to develop and commercialize KaliVir's lead clinical candidate, the VET2-L2 oncolytic vaccinia virus.

With a commitment to advancing innovative cancer treatments, KaliVir is actively progressing multiple therapeutic candidates towards clinical trials.