Dyve Biosciences, Inc. (“Dyve”), a clinical-stage biotech company applying its proprietary transdermal delivery technology to a broad pipeline of clinical assets, today announced a joint, two-year research collaboration with Moffitt Cancer Center. The collaboration will study Dyve’s systemic buffering agent, DYV800, utilizing its proprietary and broadly applicable transdermal delivery technology, in various cancer laboratory models developed by Robert Gillies, Ph.D., Chair, Department of Cancer Physiology, at Moffitt. If successful, the laboratory results will support the advancement of DYV800 into focused human trials for specific oncology indications.

Dr. Gillies’ published pre-clinical research has shown that pH-adjusting agents can successfully modify the acidic microenvironment within tumors that allow cancer cells to evade treatment. In 2015, Dr. Gillies and his colleagues published research demonstrating that systemic buffering increased the efficacy of checkpoint inhibitors in animal models of cancer. The research concluded that many solid tumors are known to create an acidic microenvironment that protects it from the body’s normal defenses and decreases the effect of anticancer therapy.1

Dyve’s buffering agent is expected to decrease the acidic microenvironment in tumors, thereby better allowing the body’s own immunological defense mechanisms to better penetrate the tumor, and hence, increasing the effectiveness of current anti-cancer agents. Dyve’s investigational candidate, DYV702, which leverages a similar buffering mechanism of action as DYV800, recently demonstrated a strong dose-dependent response in a Phase 2 program in patients with acute gout pain flares and was shown to be well-tolerated.

Ryan Beal, M.D., Chief Executive Officer of Dyve, stated, “This collaboration is a fortuitous convergence of Dr. Gillies’ long-standing, world-renowned research on the tumor microenvironment and the successful development of transdermal buffering agents at Dyve. We are excited about this opportunistic collaboration because it signals our entry into the cancer area with a novel mechanistic class of therapeutic agents that we expect to advance into the clinic to treat specific cancers. Our experience with DYV702 validates our novel scientific platform for transdermal delivery and underscores our ability to deliver clinically meaningful levels of buffering capacity into the human body.”

Dr. Gillies commented, “Our prior attempts to orally deliver our published therapy to patients failed due to poor taste and poor compliance. The prospect of transdermal delivery is truly exciting and may be a game changer.”

Dr. Shari Pilon-Thomas, also of Moffitt Cancer Center and a colleague of Dr. Gillies, added, “We have been hoping that we can study in the laboratory an investigational agent like DYV800 since the results will provide validation of our hypotheses in cancer patients, and we are thrilled to be collaborating with our new partners at Dyve Biosciences.”