Oncothyreon and Celldex Therapeutics said today they will collaborate on a clinical trial for a combination of the former’s vaccine candidate ONT-10 and the latter’s human monoclonal antibody varlilumab (CDX-1127) in patients with advanced breast or ovarian cancer. The value of the clinical collaboration was not disclosed.
The Phase Ib trial will be an open-label study that will primarily assess the safety and tolerability of the combo, which consists of a single dose of ONT-10 and two doses of varlilumab. Additional trial objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses and anti-tumor effects.
ONT-10 targets MUC1, a tumor-associated antigen that is present on many types of human malignant tumors, including lung, breast, colorectal, prostate and ovarian cancer. ONT-10 contains Oncothyreon’s adjuvant PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist.
Varlilumab targets CD27, which is known to play a critical role in the activation pathway of lymphocytes. In lymphoid malignancies that express CD27 at high levels, varlilumab has an additional mechanism through a direct antitumor effect.
Under the companies’ collaboration agreement, Oncothyreon will conduct and fund the Phase Ib trial. Oncothyreon plans to submit a new IND application for the combination trial.
Oncothyreon and Celldex will jointly own data from the trial and will jointly plan any potential future development of the combination therapy. Neither company has granted the other a license, or any other rights, to its product candidate.
"We believe the combination of a therapeutic vaccine with an agent which activates T cells has the potential to be particularly exciting,” Diana Hausman, M.D., Oncothyreon’s CMO, said in a statement.
Added Tom Davis, M.D., Celldex’ svp and CMO: "We believe combination approaches represent the future of immuno-oncology and look forward to starting this study and gathering more information on the potential of varlilumab in combination with this promising MUC1 vaccine and other potentially complementary agents."