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Oncothyreon Files Investigational New Drug Application for ONT-10


12/20/2011 10:28:19 AM

SEATTLE, WA, Dec. 20, 2011 /PRNewswire/ -Oncothyreon Inc. (Nasdaq: ONTY) today announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA's review of the IND, Oncothyreon expects to initiate a Phase 1 trial of ONT-10.

"We are pleased to announce the filing of this IND, which is a significant milestone for our therapeutic vaccine development program," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "ONT-10 and its adjuvant component, PET-Lipid A, were internally discovered and developed and remain fully owned by Oncothyreon."

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 was designed to stimulate both the humoral and cellular arms of the immune response. Preclinical results demonstrated that administration of ONT-10 produces a robust antibody response in mice specific for human tumor MUC1. A strong cellular immune response directed to the target was also shown. Additionally, the adjuvant component of ONT-10, PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist discovered by Oncothyreon, was shown to have enhanced potency compared to the adjuvant monophosphoryl lipid A (MPL).

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, visit www.oncothyreon.com.

Forward Looking Statements

In order to provide Oncothyreon's investors with an understanding of its current intentions and future prospects, this release contains statements that are forward looking, including statements related to future clinical development plans for our product candidates. These forward-looking statements represent Oncothyreon's intentions, plans, expectations and beliefs and are based on its management's experience and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances.

Forward-looking statements involve risks and uncertainties, including risks and uncertainties related to Oncothyreon's business and the general economic environment. Many of these risks and uncertainties are beyond Oncothyreon's control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements. Risks, uncertainties, and assumptions include those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, the safety and efficacy of our product candidates, and the indications for which our product candidates might be developed. There can be no guarantee that the results of preclinical studies or clinical trials will be predictive of either safety or efficacy in future clinical trials. These and other risks and uncertainties are described in the reports and other documents filed by Oncothyreon Inc. with the SEC and/or Canadian regulatory authorities.

Although Oncothyreon believes that any forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR and in Canada on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

SOURCE Oncothyreon Inc.


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