Celldex, Oncothyreon Partner On Cancer Immunotherapy Trial
Celldex Therapeutics and biotech Oncothyreon announced that the companies have entered into a collaboration to conduct a combined clinical trial of ONT-10 and varlilumab as cancer immunotherapy in advanced breast or ovarian cancer.
ONT-10 is a therapeutic vaccine designed to target MUC1, an antigen associated with tumors that is found on many types of human malignant tumors. The vaccine contains a glycosylated antigen that mimics the hypoglycosylated state of tumor-associated MUC1 and intends to stimulate both the humoral and cellular arms of the immune system’s response.
Varlilumab is a fully human monoclonal antibody designed to target CD27, a molecule that plays a critical part in lymphocytes’ activation pathway. The antibody has demonstrated the ability to induce activation and proliferation of human T cells when combined with T-cell receptor stimulation.
The companies plan an open-label Phase IB study of ONT-010 in combination with varlilumab in up to 42 patients with advanced ovarian or breast cancer. The trial’s primary objective is to determine the safety and tolerability of the combination treatment, however researchers have also set additional objectives including assessment of the combined therapy’s impact on MUC1-specific humoral and cellular immune responses and anti-tumor effects.
Diana Hausman, CMO at Oncothyreon, said, “Recent advances in the immunotherapy of cancer have created new opportunities for evaluating the effectiveness of combination approaches.” Hausman said that combining a therapeutic vaccine with a T-cell activating agent presents interesting therapeutic potential.
“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, SVP and CMO of Celldex. Davis said that combination approaches are the new frontier immuno-oncology and that the companies anticipate investigating varlilumab in combination with the MUC1 vaccine as well as other potentially complementary agents.
The combined clinical trial will be managed and financed by Oncothyreon. The company will also submit a new Investigational New Drug (IND) application for the trial. No license or rights to any of the product candidates have been granted to either company under the agreement.