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KaliVir's Oncolytic Immunotherapy VET3-TGI Receives FDA IND Clearance for Solid Tumor Trial

• KaliVir Immunotherapeutics received FDA clearance for its IND application for VET3-TGI, an oncolytic immunotherapy, to treat advanced solid tumors. • The Phase 1/1b study (STEALTH-001) will assess VET3-TGI's safety and efficacy as a monotherapy and in combination with checkpoint inhibitors. • VET3-TGI targets and kills tumor cells while stimulating anti-cancer immunity through interleukin-12 and TGFbeta inhibitor expression. • This trial marks KaliVir's second clinical trial initiation from its VET platform, following progress with ASP1012 licensed to Astellas.

KaliVir Immunotherapeutics, Inc. has announced that the FDA has cleared the Investigational New Drug (IND) application for VET3-TGI, a novel oncolytic immunotherapy, in patients with incurable, advanced solid tumors. The Phase 1/1b study, named STEALTH-001 (ClinicalTrials.gov ID NCT06444815), will evaluate the safety and efficacy of VET3-TGI when administered intravenously or intratumorally, both as a monotherapy and in combination with checkpoint inhibitor therapy.
VET3-TGI is designed to selectively target and kill tumor cells while simultaneously stimulating anti-cancer immunity. This is achieved through the expression of transgenes for interleukin-12 (IL-12) and a TGFbeta inhibitor, which are intended to modify the tumor microenvironment and enhance the immune response against the cancer.

Clinical Trial Details

The Phase 1/1b study will enroll patients with advanced, incurable solid tumors. The trial aims to determine the optimal dosing regimen and assess the safety profile of VET3-TGI. Efficacy will be evaluated by measuring tumor response rates and progression-free survival. The study will include both monotherapy and combination therapy arms, where VET3-TGI is administered alongside checkpoint inhibitors.

Executive Commentary

"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. She also noted that this is their second clinical trial from the VET platform, following progress with ASP1012 exclusively licensed to Astellas.

About KaliVir's VET Platform

KaliVir's Vaccinia Enhanced Template (VET) platform is designed to generate potent oncolytic vaccinia viruses. These viruses are modified to maximize viral replication and enhance intravenous delivery and spread. The VET platform leverages the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes, stimulating patients’ immune systems and modifying the tumor microenvironment. KaliVir has collaborations with Roche and Astellas Pharma to develop novel oncolytic vaccinia viruses derived from the VET platform.
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Related Clinical Trials

A Study of VET3-TGI in Patients With Solid Tumors

NCT06444815RecruitingPhase 1
KaliVir Immunotherapeutics
Posted 9/16/2024

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Reference News

[1]
KaliVir Immunotherapeutics Announces FDA Clearance of Investigational New Drug (IND) for Oncolytic Immunotherapy VET3-TGI for Solid Tumors
finance.yahoo.com · Jul 1, 2024

KaliVir Immunotherapeutics announced FDA clearance for the STEALTH-001 study of VET3-TGI, a novel oncolytic immunotherap...

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