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).
