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KaliVir Immunotherapeutics Doses First Patient in Phase I/Ib Trial of VET3-TGI for Advanced Solid Tumors

• KaliVir Immunotherapeutics has dosed the first patient in a Phase I/Ib trial of VET3-TGI, an oncolytic immunotherapy for advanced solid tumors. • VET3-TGI utilizes a dual mechanism, selectively killing tumor cells and stimulating the immune system via interleukin-12 and a TGF-beta inhibitor. • The trial will assess the safety and efficacy of VET3-TGI through dose escalation and expansion stages, with both direct tumor injection and intravenous infusion. • The study includes exploration of VET3-TGI as a monotherapy and in combination with checkpoint blockade therapy to determine the optimal treatment approach.

KaliVir Immunotherapeutics has commenced a Phase I/Ib clinical trial, STEALTH-001, evaluating VET3-TGI, a novel oncolytic immunotherapy, in patients with incurable advanced solid tumors. The first patient has been dosed, marking a significant step in the development of this innovative treatment approach.
VET3-TGI employs a dual-action mechanism to target tumor cells. It selectively kills cancer cells while simultaneously stimulating the immune system through the delivery of interleukin-12 and a TGF-beta inhibitor. This approach aims to enhance the body's natural defenses against the tumor.
The Phase I/Ib trial is designed to assess the safety and efficacy of VET3-TGI through dose escalation and expansion phases. Patients will receive the treatment either by direct injection into the tumor or intravenously. The dose escalation phase will determine the maximum tolerated dose of VET3-TGI when administered via different routes, including in combination with checkpoint blockade therapy.

Trial Design and Objectives

Following the dose escalation phase, the trial will proceed to expansion cohorts. These cohorts will further investigate the safety profile and therapeutic effectiveness of VET3-TGI. The study is currently enrolling subjects with pathologically confirmed advanced, unresectable, or metastatic solid tumors.
KaliVir's chief medical officer, James Burke, stated, "The dosing of our first patient in the STEALTH-001 study marks a significant milestone for KaliVir and our innovative VET3-TGI programme. The unique engineering of this platform to selectively target the tumour, even in the face of anti-viral immunity, holds great promise in delivering potent immune stimulatory cargo intravenously in patients with advanced solid tumours. Both VET3-TGI monotherapy and combination with checkpoint inhibition will be explored in this initial study."

KaliVir's Oncolytic Immunotherapy Platform

KaliVir focuses on developing next-generation oncolytic immunotherapies. The company leverages its vaccinia-enhanced template (VET) platform to engineer viral backbones that enhance the delivery and targeted expression of therapeutic transgenes within tumors. This platform is designed to facilitate the systemic delivery of innovative cancer treatment candidates.
KaliVir’s ASP1012, another oncolytic immunotherapy candidate, is also currently in a Phase I clinical trial and being developed in partnership with Astellas Pharma.
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Reference News

[1]
KaliVir doses first subject in Phase I/Ib solid tumour treatment trial
clinicaltrialsarena.com · Oct 9, 2024

KaliVir Immunotherapeutics has initiated a Phase I/Ib clinical trial for VET3-TGI, an oncolytic immunotherapy targeting ...

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