UbiVac Announces Clinical Trial Collaboration with Bristol Myers Squibb

UbiVac, Inc. announced it has entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001, a first-in-class cancer vaccine that exploits autophagy, in combination with Bristol Myers Squibb’s anti-OX40 (BMS-986178) combined with sequenced administration of the programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b multicenter trial will test the hypothesis that combination immunotherapy with the DPV-001 cancer vaccine and anti-OX40 will augment anticancer immunity in patients with advanced triple negative breast cancer.

Triple Negative Breast Cancer is negative for estrogen receptors, progesterone receptors and HER2 receptors, and therefore treatment options are limited. This type of breast cancer tends to metastasize frequently, and occur in younger patients (less than 50 years of age) and those with the inherited BRCA1 mutation.

This is the first clinical trial to combine a cancer vaccine (DPV-001), that educates the immune system to destroy cancer cells, with a T cell agonist, Bristol Myers Squibb’s anti-OX40 (BMS-986178), that amplifies immune system activity. Patients also will receive anti-programmed death 1 immune checkpoint therapy, Bristol Myers Squibb’s Opdivo, which takes the brakes off the immune system.

“UbiVac is thrilled to be working with Bristol Myers Squibb, a world leader in immuno-oncology, to research this innovative cancer vaccine therapy, combined with anti-OX40 and checkpoint blockade, and evaluate whether this treatment boosts anticancer immunity in patients with advanced Triple Negative Breast Cancer,” said Bernard A. Fox, PhD., President and CEO of UbiVac and the Harder Family Chair for Cancer Research at the Earle A. Chiles Research Institute and Providence Cancer Institute. The trial will be led by David Page, MD, at Providence Portland Medical Center and enroll patients in Portland and at other centers in the U.S. “I am excited to lead this first-in-human trial, which builds on 25 years of immunotherapy research from the Earle A. Chiles Research Institute,” said Dr. Page. “We believe that cutting-edge immunotherapy combinations have the potential to induce long-lasting anticancer immunity and translate into clinical responses in patients with triple negative breast cancer.”