KaliVir Immunotherapeutics Begins Phase 1/1b Trial of VET3-TGI for Advanced Solid Tumors

KaliVir Immunotherapeutics, Inc., a biotechnology company specializing in advanced oncolytic viral immunotherapy, has initiated the first phase of its STEALTH-001 clinical trial by administering VET3-TGI to its inaugural patient. This novel oncolytic immunotherapy aims to combat incurable, advanced solid tumors. VET3-TGI is engineered to selectively target and eliminate tumor cells and includes an immuno-stimulatory transgene payload made up of interleukin-12 and a TGF-beta inhibitor.

James Burke, M.D., the Chief Medical Officer at KaliVir Immunotherapeutics, highlighted the importance of this development, stating, “The administration of VET3-TGI to our first patient in the STEALTH-001 study is a significant moment for KaliVir and our pioneering VET3-TGI program. The platform's unique ability to target tumors while overcoming anti-viral immunity shows great promise in delivering potent immune stimulatory agents intravenously to patients with advanced solid tumors. This trial will explore VET3-TGI both as a standalone therapy and in combination with checkpoint inhibitors.”

The STEALTH-001 clinical trial (ClinicalTrials.gov No. NCT06444815) is a dose escalation and expansion study. VET3-TGI will be administered directly into tumors or through intravenous infusion. The trial will determine the highest tolerated dose of VET3-TGI when injected directly into tumors, when given intravenously, and when combined with checkpoint inhibitors. After establishing the maximum tolerated dose for each method, expansion cohorts will be set up to further assess the safety and effectiveness of VET3-TGI. The trial includes patients with advanced, unresectable, or metastatic solid tumors confirmed through pathology.

Jorge Nieva, M.D., an Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and a member of KaliVir’s Medical Advisory Board, noted the potential impact of VET3-TGI. He commented, “VET3-TGI could fundamentally change our approach to treating advanced tumors and provide new avenues for patients in urgent need of better treatment options. This milestone is crucial, and I anticipate significant progress from VET3-TGI both as a monotherapy and in combination with checkpoint inhibitor treatment.”

KaliVir Immunotherapeutics is a leader in clinical-stage biotechnology, dedicated to the development of next-generation oncolytic immunotherapies. Utilizing the vaccinia virus platform, KaliVir creates optimized viral backbones that serve as innovative cancer treatment candidates. Their Vaccinia Enhanced Template (VET™) platform integrates various genetic modifications, enabling the systemic delivery of oncolytic vaccinia candidates and the targeted expression of therapeutic genes within tumors.

The company is expanding its pipeline through the VET™ platform, which has been validated via strategic global partnerships with Astellas Pharma and Roche. Currently, KaliVir has two product candidates in Phase 1 clinical trials: ASP1012, which is exclusively licensed and led by Astellas Pharma, and VET3-TGI, the company’s internal lead candidate. With numerous therapeutic candidates advancing through clinical stages, KaliVir positions itself as an innovator in cancer treatments.

KaliVir Immunotherapeutics is based in Pittsburgh, Pennsylvania, and is dedicated to transforming cancer treatment.