KaliVir Immunotherapeutics has announced the successful completion of the first cohort in its STEALTH-001 study, a Phase 1/1b clinical trial evaluating VET3-TGI in patients with incurable, advanced solid tumors. Following review of safety data from the initial intratumoral patients, the Data Safety Committee has cleared the company to proceed with dosing for subsequent intratumoral (IT) and intravenous (IV) cohorts.
VET3-TGI represents a novel approach in cancer immunotherapy, designed to selectively target and kill tumor cells while simultaneously delivering an immuno-stimulatory transgene payload. This dual-action therapy combines interleukin-12 and a TGFbeta inhibitor to potentially enhance anti-tumor immune responses.
Promising Safety Profile Enables Dose Escalation
The favorable safety results from this first-in-human cohort mark a significant milestone for KaliVir's clinical program. The STEALTH-001 trial (NCT06444815) will now advance to higher dose levels in both administration routes.
"The safety profile demonstrated in our initial first-in-human cohort is critical as it opens up expanded dosing in both the study's IV infusion and IT injection arms which will continue in parallel on study STEALTH-001," said James Burke, M.D., Chief Medical Officer of KaliVir Immunotherapeutics. "We are excited to assess not only the safety of VET3-TGI but further investigate both proof of concept and anti-tumor activity moving forward."
Trial Design and Patient Population
STEALTH-001 employs a dose escalation and expansion design to evaluate VET3-TGI through two administration routes: direct intratumoral injection and intravenous infusion. The study is assessing the therapy both as a monotherapy and in combination with checkpoint inhibitors.
The trial focuses on patients with pathologically confirmed advanced, unresectable, or metastatic solid tumors who have limited treatment options. This population represents a significant area of unmet medical need in oncology, where new therapeutic approaches are urgently required.
Innovative Platform Technology
VET3-TGI is developed using KaliVir's proprietary Vaccinia Enhanced Template (VET™) platform, which leverages the unique advantages of the vaccinia virus. The platform integrates multiple genetic modifications to create oncolytic viral candidates capable of systemic delivery and targeted expression of therapeutic transgenes within tumors.
This approach differentiates KaliVir's technology from other oncolytic virus therapies by potentially enabling both direct tumor cell killing and stimulation of anti-tumor immune responses through the expression of immunomodulatory payloads.
Strategic Importance and Future Directions
"Completing this first cohort reinforces our commitment to advancing our VET platform and its potential to address significant unmet needs in oncology," said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. "We remain focused on our mission to develop novel oncolytic virus candidates with the potential to transform the treatment landscape for patients with advanced cancer."
The advancement of VET3-TGI represents part of KaliVir's broader pipeline development strategy. The company has established strategic partnerships with major pharmaceutical companies, including Astellas Pharma and Roche, validating the potential of its technology platform.
In addition to VET3-TGI, KaliVir is advancing ASP1012, a candidate exclusively licensed to and being developed by Astellas Pharma, which is also in Phase 1 clinical trials. These parallel development programs highlight the versatility and potential broad applicability of KaliVir's oncolytic immunotherapy approach.
As the STEALTH-001 trial progresses through its dose escalation phase, oncology researchers and clinicians will be watching closely for early signals of efficacy that could indicate VET3-TGI's potential to address the significant challenges in treating advanced solid tumors.
