UbiVac and Bristol Myers Squibb have announced plans to collaborate on a clinical trial to test whether a combination therapy approach can boost cancer immunity in patients with advanced triple negative breast cancer.
The Phase 1b trial will evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001, in combination with Bristol Myers Squibb’s anti-OX40 (BMS-986178) and the programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab, also by Bristol Myers Squibb).
The trial will be the first to combine a cancer vaccine with a T-cell agonist (a compound that stimulates T-cells) and an anti-PD-1 immune checkpoint therapy.
“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,” David Page, MD, of the Providence Portland Medical Center, who will lead the trial, said in a press release.
Triple negative breast cancer has proven to be an elusive target because these cancer cells lack many of the receptors that make viable therapeutic targets.
Immune cells called T-cells can recognize receptors embedded in a cell’s membrane and can be trained to treat these as “foreign,” thereby mounting an immune response. Triple negative breast cancer got its name because it lacks, or is negative for, three such receptors: estrogen, progesterone, and HER2.
This type of cancer is more common in women who are younger than 40 and have a BRCA1 mutation. It tends to progress quickly and to metastasize frequently, meaning that it can spread to many other parts of the body.
DPV-001, also known as DRibble, is a cancer vaccine that has shown wide anti-cancer activity in several preclinical and clinical studies. It contains a mix of proteins meant to enhance the immune response and to “educate” T-cells on targeting cancer cells.
These proteins include those thought to represent the most dominant types of epitopes, or molecules recognized by antibodies, found on cancer cells, as well as multiple TLR and NOD agonists, DAMPs, and chaperones, all of which contribute to educating T-cells.
Anti-OX40 is a monoclonal antibody that stimulates T-cells while Opdivo is another such antibody that further stimulates T-cell activity by blocking the PD-1 immune checkpoint inhibitor, which normally holds T-cells in check until the body senses the need to mount an immune response.
“I am excited to lead this first-in-human trial,” Page said, “which builds on 25 years of immunotherapy research from the Earle A. Chiles Research Institute.”