 has approved the Investigational New Drug (IND) application for the STEALTH-001 study.){kind=link}
KaliVir Immunotherapeutics, Inc., a biotech firm pioneering multi-mechanistic oncolytic viral immunotherapy programs, announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the STEALTH-001 study. This trial will investigate the efficacy and safety of VET3-TGI in patients with advanced, incurable solid tumors.
VET3-TGI, an innovative oncolytic immunotherapy, has shown promise in preclinical studies by targeting and destroying tumor cells while simultaneously enhancing anti-cancer immunity through its therapeutic payload, which includes interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b clinical trial (ClinicalTrials.gov ID NCT06444815) will explore VET3-TGI’s safety and effectiveness when administered either intravenously or via intratumoral injection. The study will also evaluate the therapy both as a standalone treatment and in combination with checkpoint inhibitor therapy.
“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,” said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. “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.”
KaliVir Immunotherapeutics is at the forefront of developing advanced oncolytic viral therapies using their proprietary Vaccinia Enhanced Template (VET™) platform. This platform produces powerful oncolytic vaccinia viruses that enhance viral replication and delivery. The VET™ platform’s large transgene capacity allows it to deliver therapeutics tailored to tumor immunophenotypes, stimulating patients’ immune systems and modifying the tumor microenvironment.
KaliVir’s oncolytic virus candidates aim to be safe, potent, and systemically deliverable, offering potential treatments across multiple tumor types. The company has established collaborations with Roche and Astellas Pharma to develop novel oncolytic vaccinia viruses. Additionally, Astellas has an exclusive global license to develop and commercialize KaliVir’s lead clinical candidate VET2-L2.