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Oncothyreon and Celldex Therapeutics Announce Collaboration for Combination Immunotherapy Clinical Trial of ONT-10 and Varlilumab

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May 29, 2014

Oncothyreon Inc. and Celldex Therapeutics, Inc., today announced that they 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 1b 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. “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.”

The collaboration agreement provides that Oncothyreon will supply ONT-10 and Celldex will supply CDX-1127. The Phase 1b trial will be conducted and funded by Oncothyreon, which plans to submit a new Investigational New Drug (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. Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.

About ONT-10

ONT-10 is a therapeutic vaccine targeting MUC1, a tumor-associated antigen present on many types of human malignant tumors, including lung, breast, colorectal, prostate and ovarian cancer. ONT-10 contains a glycosylated antigen designed to mimic the hypoglycosylated state of tumor-associated MUC1 and intended to stimulate both the humoral and cellular arms of the immune response. Additionally, ONT-10 contains the adjuvant PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist proprietary to Oncothyreon. In an ongoing Phase 1 trial ONT-10 has been well-tolerated, has led to a robust anti-MUC1 antibody response, and has been associated with prolonged stable disease of greater than six months in advanced stage patients. Oncothyreon currently plans to expand the Phase 1 trial in two disease-specific cohorts in patients with advanced breast or ovarian carcinoma.

About Varlilumab

Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. CD27 can be effectively manipulated with activating antibodies to induce potent anti-tumor responses, and may result in less toxicities due to its restricted expression and regulation. Varlilumab is a potent anti-CD27 agonist that induces activation and proliferation of human T cells when combined with T-cell receptor stimulation. In lymphoid malignancies that express CD27 at high levels, varlilumab has an additional mechanism through a direct anti-tumor effect. In ongoing Phase 1 trials varlilumab has shown an excellent safety profile and demonstrated clear biologic activity and promising signs of clinical activity in an advanced, refractory patient population.

About Oncothyreon

Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon’s goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. For more information, visitwww.oncothyreon.com.

About Celldex

Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.

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