Issue link: http://sarahcannon.uberflip.com/i/1541462
Meeting Minutes Doc. No.: IBC-FORM-19 V.01.4 Page 2 of 3 Effective Date 04 AUG 2025 Review of Prior Business: None Previous Meeting Minutes: Minutes from 7-24-25 were approved by the IBC with no changes. There were no votes against and no abstentions. New Business: Trial Summary: : STEALTH-001 is a first-in-human, open-label, Phase I/Ib study sponsored by KaliVir Immunotherapeutics, Inc. and designed to assess the safety, tolerability, recommended Phase 2 dose (RP2D), and maximum tolerated dose (MTD) of VET3-TGI, a recombinant, selectively replicating oncolytic vaccinia virus, alone or in combination with a checkpoint therapy for the treatment of adult participants with advanced solid tumors. The investigational product (IP) is administered by Intravenous Infusion or Intratumoral (Itu) Injection Biosafety Containment Level (BSL): The study agent VET3-TGI consists of a Risk-Group 2 vaccinia pox virus containing more than two-thirds of the native genome, therefore a Biosafety Level 2 (BSL-2) is the minimal recommended containment level under the NIH Guidelines. Risk Assessment and Discussion: • The Committee reviewed the clinical trial Sponsor's study documents and the Sabai-generated comprehensive study-specific Risk Assessment which collectively provided a thorough description of the recombinant or synthetic nucleic acid molecules (investigational product/s) and the proposed clinical research activities involving the IP. o In summary, the primary risks in this clinical trial include potential occupational exposure from accidental spills or splashes of the IP during preparation and/or administration procedures and needlesticks due to the use of needles during preparation and/or administration. These potential risks are mitigated through a combination of relevant staff training, safe clinical practices (including Standard Precautions and sharps safety) and use of appropriate PPE (as prescribed in the Risk Assessment and documented in the IBC submission package) [Add additional points (e.g., aerosols) [if applicable] o The Site confirmed that only study personnel who have been educated on the potential biohazards and the precautions to be taken when working with the IP will handle the IP or any materials contaminated by the IP. PI: Orr, Douglas M.D. Sponsor: KaliVir Immunotherapeutics, Inc. Protocol: STEALTH-001 A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors Review Type: Change in Research Review NIH Guidelines Section: III-C-1