Cooperative Research and Development Agreement (CRADA) assesses OX40 agonist, utomilumab and avelumab immuno-oncology assets alone and in various combinations
“We are looking forward to combining our expertise with those at the NCI to explore agents targeting the immune system in doublet and triplet combinations. Clinical studies focused on translational endpoints will allow us to optimally develop potential rational combinations."
Pfizer Inc. (NYSE:PFE) today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). As part of the CRADA, Pfizer will collaborate with NCI’s Center for Cancer Research (CCR) to arrange and conduct preclinical and clinical trials to evaluate three investigational immunotherapy agents. These include Pfizer’s proprietary immunotherapy agonistic monoclonal antibodies targeting OX40 (CD134), (also known as PF-04518600); and utomilumab, targeting 4-1BB (CD137), (also known as PF-05082566); as well as avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody (also known as PF-06834635 and MSB0010718C), which is being developed through an alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.
The collaborative preclinical and clinical studies will be co-led by Dr. Jeffrey Schlom, chief of the Laboratory of Tumor Immunology and Biology at CCR, Dr. James Gulley, chief of the Genitourinary Malignancies Branch at CCR, and Dr. Chris Boshoff, Senior Vice President and Head of Immuno-oncology, Translational Oncology and Early Development, Pfizer Global Product Development. Under the CRADA, the three investigational immunotherapies will be studied alone, in various combinations with each other, and in combination with standard therapies, such as chemotherapy, radiation and targeted therapies across a range of cancers.
“We are looking forward to combining our expertise with those at the NCI to explore agents targeting the immune system in doublet and triplet combinations. Clinical studies focused on translational endpoints will allow us to optimally develop potential rational combinations,” said Chris Boshoff. “The CRADA is an important collaboration for us as we seek to realize the full potential of immunotherapy and hope to ultimately transform the cancer treatment paradigm.”
Beyond this collaboration, Pfizer is advancing these and other assets from its growing immuno-oncology portfolio with single agent and novel combination studies, both internally and through other collaborations.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. Learn more about how Pfizer Oncology is applying innovative approaches to improve the outlook for people living with cancer at http://www.pfizer.com/research/therapeutic_areas/oncology.
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DISCLOSURE NOTICE: The information contained in this release is as of November 14, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s Cooperative Research and Development Agreement with the National Cancer Institute, Pfizer’s immuno-oncology portfolio, including OX40 (CD134), utomilumab (PF-05082566) and avelumab, potential combination therapies, the potential of immuno-oncology and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; whether and when any applications may be filed with regulatory authorities for OX40, utomilumab or avelumab, combination therapies or other immuno-oncology product candidates; whether and when regulatory authorities may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of OX40, utomilumab or avelumab, combination therapies or other immuno-oncology product candidates; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
Sally Beatty, 212-733-6566
Ryan Crowe, 212-733-8160