KaliVir Immunotherapeutics Completes First Cohort of STEALTH-001 Study on VET3-TGI for Advanced Solid Tumors

PITTSBURGH—KaliVir Immunotherapeutics, Inc., a pioneering biotechnology company at the clinical stage, has reached a significant milestone in its STEALTH-001 study. This clinical trial is a Phase 1/1b investigation of VET3-TGI, an innovative oncolytic immunotherapy designed for patients with advanced, incurable solid tumors. The primary goal of VET3-TGI is to selectively eliminate tumor cells. This is achieved while simultaneously introducing an immune-enhancing transgene payload that comprises interleukin-12 and a TGFbeta inhibitor, targeting the tumor cells effectively.

The trial's Data Safety Committee, responsible for overseeing the safety and risk-benefit profile of the therapy, has given the green light for the ongoing dose-escalation phase after completing the first cohort. This approval allows KaliVir to proceed with further dosing in both the intratumoral (IT) and intravenous (IV) infusion groups.

James Burke, M.D., the Chief Medical Officer of KaliVir Immunotherapeutics, highlighted the importance of the study's early safety profile. He emphasized that this development is crucial for broadening the dosing regimen in both IV infusion and IT injection arms, which will advance in parallel within the STEALTH-001 study. Dr. Burke expressed enthusiasm in evaluating not only the safety but also the proof of concept and anti-tumor activity of VET3-TGI as the study progresses.

The STEALTH-001 trial is structured as a dose escalation and expansion study, focusing on the administration of VET3-TGI via direct IT injection and IV infusion. The trial examines VET3-TGI both as a standalone treatment and in combination with a checkpoint inhibitor. The patient population includes individuals with histologically confirmed, advanced, unresectable, or metastatic solid tumors. The trial continues to move forward according to its dose escalation protocol.

Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics, underscored the significance of completing the first cohort, which reinforces the company's dedication to advancing its VET platform. This platform holds promise in addressing substantial unmet needs in oncology. Dr. Chaye conveyed the company's commitment to developing novel oncolytic virus candidates that could potentially transform cancer treatment options for patients with advanced stages of the disease.

KaliVir Immunotherapeutics is at the forefront of developing next-generation oncolytic immunotherapies. By leveraging the unique properties of the vaccinia platform, the company engineers optimized viral backbones to create groundbreaking cancer treatment candidates. The proprietary Vaccinia Enhanced Template (VET™) platform allows for systemic delivery of oncolytic vaccinia candidates and ensures the targeted expression of therapeutic transgenes within tumors.

The company is expanding its pipeline using the VET™ platform, with its capabilities validated through strategic partnerships with global pharmaceutical giants, Astellas Pharma and Roche. Presently, KaliVir has two product candidates in Phase 1 clinical trials: ASP1012, under exclusive license and led by Astellas Pharma, and its internal lead candidate, VET3-TGI. With several therapeutic candidates advancing through clinical development stages, KaliVir is establishing itself as a leader in innovative cancer therapies.

Based in Pittsburgh, Pennsylvania, KaliVir is dedicated to transforming cancer treatment.