US-based firms Oncothyreon and Celldex Therapeutics have agreed to collaborate in a combined clinical trial of ONT-10 and varlilumab for treatment of advanced breast or ovarian cancer.
ONT-10 is a therapeutic vaccine targeting the tumour-associated antigen MUC1, while varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.
In the planned open-label Phase Ib trial, ONT-10 is administered at the recommended single agent dose in combination with varlilumab at two dose levels in 42 patients with advanced breast or ovarian cancer.
The trial’s primary objective is to determine the safety and tolerability of the combined therapy, and additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses and anti-tumour effects.
Oncothyreon chief medical officer Diana Hausman said recent advances in the immunotherapy of cancer have created new opportunities for evaluating the effectiveness of combination approaches.
"We believe the combination of a therapeutic vaccine with an agent, which activates T-cells, has the potential to be particularly exciting," Hausman said.
Celldex senior vice-president and chief medical officer Tom Davis said the combination of an immunogenic tumour-targeted vaccine such as ONT-10 and a broad immune co-stimulator such as varlilumab could create potent immunity that may result in anti-cancer activity.
"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," Davis said.
Under the deal, Oncothyreon will supply ONT-10 and Celldex will provide CDX-1127.
The study will be carried out and funded by Oncothyreon, which intends to submit a new investigational new drug (IND) application for the combination trial.
The two firms will jointly own data from the trial and make any plans for potential future development of the combination therapy together.
Under the agreement, neither company has granted the other a licence, or any other rights, to its product candidate.