The partnership will assess the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product DRibble Platform Vaccine 001(DPV-001) in combination with BMS’ anti-OX40 (BMS-986178) combined with sequenced administration of the programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab).
UbiVac’s DPV-001 is an investigational first-in-class cancer vaccine, which exploits autophagy. The DPV-001 is a dendritic cell-targeted microvesicle containing short-lived proteins, which are believed to represent the dominant HLA-presented epitopes on the surface of cancer cells.
The Phase 1b multicenter trial will evaluate the hypothesis whether the combination immunotherapy, including DPV-001 cancer vaccine and anti-OX40, will boost anticancer immunity in patients with advanced triple-negative breast cancer.
It is claimed to be the first clinical trial to combine a cancer vaccine with a T cell agonist, which amplifies immune system activity.
In addition, the patients will secure anti-programmed death 1 immune checkpoint therapy, BMS’ Opdivo, which is said to take the brakes off the immune system.
Dr David Page will lead the trial at Providence Portland Medical Centre, and also patients will be recruited in Portland and at other centres in the US.
Page said: “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.”
UbiVac’s microvesicle vaccine is also comprised of over 100 proteins, which are overexpressed by the average triple-negative breast cancer and as many as 1700 altered peptide ligands that can enhance immunity against cancer antigens.
The combined formulation is said to stimulate B cells, CD4 and CD8 T cells as well as innate components of the host’s immune system to mediate anticancer function.
UbiVac president and CEO Bernard Fox said: “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.”
In February this year, BMS and BioMotiv have launched a new biotechnology company, Anteros Pharmaceuticals, which will involve in the development of a new class of drugs for fibrotic and other inflammatory diseases.