Dyve Biosciences Announces Research and Development Collaboration with Moffitt Cancer Center

Synergestic collaboration will evaluate DYVE’s buffering candidate delivered transdermally for future clinical oncology applications

CAMARILLO, Calif. and TAMPA, Fla., Feb. 03, 2022 (GLOBE NEWSWIRE) — 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.”

About Dyve Biosciences 

Dyve is a clinical-stage biotech company applying its proprietary transdermal delivery technology to a broad pipeline of clinical assets, including a collection of new chemical entities (NCEs) in collaboration with a major pharmaceutical company. Dyve has an emulsion-based platform technology that has succeeded where previous attempts with patches and microneedles have failed – allowing for the topical application and transdermal delivery of both simple and complex molecules that are neither suitable nor optimal for traditional oral and injectable routes of administration. Dyve’s transdermal delivery system provides a new paradigm for a universal third route of drug delivery, combining the fast onset of action and systemic availability of an injectable, with the convenience and optimal pharmacokinetic profile of an oral pill. Dyve’s goal is to set a new standard with a comprehensive transdermal delivery solution, creating therapeutics which are both patient-friendly and clinically intuitive for a wide array of indications. Dyve’s technology includes a novel approach for delivering pH-adjusting agents through the skin. This has the potential to decrease the acidic microenvironments that are key to the pathology and treatment of multiple disease states within oncology, immunology, and inflammation. For example, Dyve’s lead asset, pH-modulator DYV702, recently completed a successful multi-center, 100-patient, Phase 2 clinical study for reducing the pain associated with acute gouty arthritis. Dyve’s novel technology platform carries a robust portfolio of both pending and issued patents. For more information, please visit www.dyvebio.com

About Moffitt Cancer Center

Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 52 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 7,500 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube

Corporate Contact
Jim McGee
Dyve Biosciences, Inc.
805-857-6449
jim.mcgee@dyvebio.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com

References:

1Cancer Research, 76(6) March 15, 2016 
doi: 10.1158/0008-5472.CAN-15-174. “Neutralization of tumor acidity improves anti-tumor responses to immunotherapies”, Shari Pilon-Thomas, et al.

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