KaliVir Immunotherapeutics has dosed the first subject in a Phase I/Ib clinical trial for its new oncolytic immunotherapy, VET3-TGI, designed to treat patients with incurable advanced solid tumours.
VET3-TGI uses a dual approach to target tumour cells by selectively killing them and stimulating the immune system through interleukin-12 and a TGF-beta inhibitor.
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The trial will assess VET3-TGI’s safety and efficacy through dose escalation and expansion stages.
Patients will receive the treatment either by direct tumour injection or intravenous infusion.
The dose escalation portion aims to establish the highest tolerated dose of VET3-TGI across different methods of administration, including when combined with checkpoint blockade therapy.
Following the determination of the maximum tolerated dose for each administration group, the trial will proceed to expansion cohorts, which are designed to further investigate the safety profile and therapeutic effectiveness of VET3-TGI.
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By GlobalDataThe study is currently enrolling subjects who have pathologically confirmed advanced, unresectable, or metastatic solid tumours.
KaliVir focuses on developing next-generation oncolytic immunotherapies.
The company leverages the capabilities of the vaccinia platform to engineer viral backbones that enhance the delivery and targeted expression of therapeutic transgenes within tumours.
Its vaccinia-enhanced template (VET) platform is instrumental in the systemic delivery of these 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.
KaliVir Immunotherapeutics 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.”
