Phase II Amount
$1,371,030
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 Vivreons 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). Public Health Relevance Statement 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 Narrative Vivreon Biosciences is conducting investigational new drug (IND)-enabling studies for VV2003, a novel therapeutic to improve outcomes in persons undergoing checkpoint inhibitor immunotherapy. Checkpoint inhibitors have improved overall survival in numerous cancers, but severe diarrhea and enterocolitis side effects limit the effectiveness of these drugs. VV2003 addresses this urgent unmet clinical need through colon-specific immunosuppression, without systemic side effects, by selective blockade of gut-resident inflammatory Ca2+ release activated Ca2+ (CRAC) channels.
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