IND-Enabling Toxicology for a Novel Ca2+ Channel Therapeutic to Improve Outcomes Associated with Checkpoint Inhibitor Immunotherapy

Vivreon Biosciences, LLC 4940 Carroll Canyon Rd. Suite 110 San Diego, CA 92121 milton@vivreonbiosciences.com Vivreon Biosciences, LLC, NCI SBIR Direct to Phase II, Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications, PA-21-259 IND-Enabling Toxicology for VV2003, a Novel CRAC Channel Therapeutic, to Improve Outcomes Associated with Checkpoint Inhibitor Immunotherapy Project Summary Vivreon Biosciences is pleased to apply for NCI SBIR Solicitation PA-21-259. Vivreon is an innovative life sciences company that is developing a novel small molecule Ca2+ channel inhibitor, VV2003, to improve outcomes in persons undergoing immune checkpoint inhibitor immunotherapy. Checkpoint inhibitors have improved overall survival in numerous cancers, but enterocolitis has emerged as the most frequent dose-limiting toxicity associated with these therapies. Checkpoint inhibitor-induced colitis is currently treated with immunosuppressive therapy, which blunts the tumor-killing potential of the checkpoint inhibitor immunotherapy and is administered following checkpoint therapy discontinuation. VV2003 is an oral candidate therapeutic designed to selectively and safely block checkpoint inhibitor-induced enterocolitis without systemic immunosuppressive side effects. It is intended to be used concomitantly with checkpoint inhibitors, allowing immunotherapy to continue, separating it from other investigational therapies. Vivreon seeks NCI Phase 2 funding for investigational new drug (IND)-enabling good laboratory practice (GLP) toxicity, safety, and genotoxicity studies. Specifically, NCI funding will go towards dose range finding toxicity studies, two-species GLP 28-day toxicity studies, GLP safety pharmacology and genetic toxicology, GLP pharmacological respiratory safety assessment, and GLP cardiovascular telemetry. Activities in this proposal will run in parallel with chemistry manufacturing and controls (CMC) processes that will be funded by Vivreon’s Seed investor. Completion of these studies will support and be written up in an IND application, with the final milestone being IND submission to the US Food and Drug Administration (FDA).