Oncothyreon, a biotechnology company developing therapeutic products for the treatment of cancer, and Celldex Therapeutics have agreed to collaborate on a combined clinical trial of ONT-10 and varlilumab.
ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.
The planned trial is an open-label phase Ib study of ONT-10, administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses and anti-tumor effects.
"Recent advances in the immunotherapy of cancer have created new opportunities for evaluating the effectiveness of combination approaches," said Diana Hausman, M.D., chief medical officer at Oncothyreon. "We believe the combination of a therapeutic vaccine with an agent which activates T-cells has the potential to be particularly exciting."
"The combination of an immunogenic tumor-targeted vaccine such as ONT-10 and a broad immune co-stimulator like varlilumab could create potent immunity that may result in anticancer activity, either together or in combination with a checkpoint inhibitor," said Tom Davis, M.D., senior vice president and chief medical officer of Celldex.
The collaboration agreement provides that Oncothyreon will supply ONT-10 and Celldex will supply CDX-1127. The phase Ib trial will be conducted and funded by Oncothyreon, which plans to submit a new IND application for the combination trial. Oncothyreon and Celldex will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together. Neither company has granted the other a license, or any other rights, to its product candidate.