UbiVac announces clinical trial collaboration with Bristol Myers Squibb on combination immunotherapy for advanced triple negative breast cancer

Phase Ib study to combine UbiVac’s DRibble® Platform Vaccine, DPV-001 with anti-OX40 (BMS-986178) and Opdivo (nivolumab) to test hypothesis that this combination will augment anticancer immunity in advanced triple negative breast cancer

PORTLAND, Ore.– UbiVac, Inc. (www.ubivac.com) today announced it has entered into a clinical trial collaboration with Bristol Myers Squibb (NYSE:BMY) 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.”

About UbiVac’s Innovative Cancer Vaccine Technology

The lead biologic, DRibble Platform Vaccine 001, DPV-001, is a dendritic cell-targeted microvesicle containing short-lived proteins that are thought to represent the dominant HLA-presented epitopes on the surface of cancer cells. These microvesicles are packaged with multiple TLR and NOD agonists, together with 15 DAMPs and chaperones. The microvesicle vaccine also contains more than 100 proteins that are overexpressed by the average triple negative breast cancer and as many as 1700 altered peptide ligands that can augment immunity against cancer antigens. Together this formulation drives B cells, CD4 and CD8 T cells as well as innate components of the host’s immune system to mediate anticancer function.

In preclinical models this vaccine can convert tumors that are considered “cold” because they lack immune cells into tumors that are “hot” with cancer killer cells. This is important as many human tumors are thought to be unresponsive to immunotherapy because they lack immune cells capable of recognizing their cancer and are considered to be “cold” tumors. “Based on these data we believe UbiVac’s DRibble platform vaccine technology combined with anti-OX40 will light a fire in the immune system of patients with cold tumors, turning them into hot tumors that will be more responsive to checkpoint blockade,” Hong-Ming Hu, PhD, CSO at UbiVac, said.

About UbiVac

UbiVac is a privately held, clinical stage immunotherapy company engaged in the research and development of therapeutic vaccines to combat cancer. With innovative, first-in-class platform technology that couples an off-the-shelf DC-targeted cancer vaccine with more than 100 cancer antigens for most adenocarcinomas and squamous cell cancers, UbiVac believes it is highly complementary to current and developing drug portfolios. UbiVac also has a pipeline of vaccines under development to target COVID-19, rare diseases and to prevent cancer in patients at high risk of developing disease. Founded by Dr. Bernard A. Fox, Dr. Hong-Ming Hu and Mr. Bernard A. Fox, in Portland, Oregon in 2005, UbiVac is a spinout of the Robert W. Franz Cancer Center, Earle A. Chiles Research Institute at Providence Portland Medical Center. In 2011 UbiVac, in cooperation with Oregon Health & Science University (OHSU), created UbiVac CMV to license sdCMV.

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