LEXINGTON, Mass.--(BUSINESS WIRE)--
Agenus Inc. (AGEN), a developer of therapeutic vaccines for cancer and infectious diseases, today announced that its Prophage Series (HSPPC-96) vaccine program for the treatment of brain cancer was selected as a 2013 Top Project to Watch in oncology. This selection was made through Elsevier Business Intelligence's panel of independent experts who screen hundreds of programs and weigh their potential as future products.
The company also announced that Jennifer S. Buell, Ph.D., Vice President of Clinical Research and Operations, will present an overview of the ongoing Prophage Series vaccine Phase 2 program in newly diagnosed and recurrent glioblastoma multiforme (GBM) at the 2013 Therapeutic Area Partnerships Conference on Tuesday, November 19, 2013 at 1:10 pm EST at the Hyatt Regency in Boston, MA.
A recent analysis from the Phase 2 trial in patients with newly diagnosed GBM treated with Prophage Series in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival, which represents a 160% increase versus current standard of care alone.1 Median overall survival (OS), the primary endpoint of the trial, is 23.3 months and remains durable in patients treated with Prophage Series vaccine versus the standard of care alone, which is 14.6 months.1 Patients continue to be followed for survival. Based on these findings, Agenus plans to hold an end of Phase 2 meeting with the US Food and Drug Administration to discuss a Phase 3 trial that, if initiated and successful, could potentially lead to marketing approval of the Prophage Series vaccine as a treatment for patients with newly diagnosed GBM.
In addition to the Phase 2 newly diagnosed GBM trial, the National Cancer Institute (NCI) is supporting a study of the Prophage Series vaccine in a large, randomized Phase 2 trial in combination with bevacizumab (Avastin®) in patients with surgically resectable recurrent GBM. The study is being sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI. This trial is the largest brain tumor trial ever funded by the NCI and the largest vaccine study ever conducted with Avastin.
The ALLIANCE trial is investigating the potential benefits of treatment with a combination of Prophage Series and bevacizumab in a three-arm study of approximately 222 patients with surgically resectable recurrent GBM using a primary endpoint of OS. The study will compare efficacy of the Prophage Series vaccine administered with bevacizumab either concomitantly or at progression, versus treatment with bevacizumab alone. For additional information about the ALLIANCE trial visit ClinicalTrials.gov using Identifier NCT01814813.
About Prophage Series Vaccines
Derived from each individual’s tumor, Prophage Series therapeutic vaccines contain the ‘antigenic fingerprint’ of the patient’s particular cancer and are designed to direct the body’s immune system to specifically target and destroy cancer cells bearing this fingerprint. Prophage Series vaccines, based on Agenus’ heat shock protein platform technology, are intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy.
Each patient’s cancer is unique. Random mutations and tens of thousands of genes mean even within the same type of cancer, no two individuals’ cancers are biologically the same. Taking these factors into account, the Prophage Series vaccines are developed from the best biological representation of a patient’s cancer and created individually for each patient from their own tumor.
The Prophage Series vaccines are currently being studied in both newly diagnosed and recurrent GBM. GBM is the most aggressive primary malignant brain tumor and accounts for the majority of diagnoses of malignant cancers of the brain.
For more information about Prophage Series vaccines and Agenus’ heat shock protein platform, please visit http://agenusbio.com/science/prophage.php.
Agenus Inc. is a biotechnology company developing treatments for cancers and infectious diseases. The company has multiple immunotherapeutic products based on strong technology platforms that are advancing through the clinic. Agenus’ technology is further validated through partnerships with major pharmaceutical companies, with several product candidates in late-stage clinical trials with corporate partners. For more information, please visit www.agenusbio.com.
About Elsevier Business Intelligence and the Therapeutic Area Partnerships Conference
Elsevier Business Intelligence provides business intelligence on regulatory, business and reimbursement issues that are vital to the healthcare industry. Through a range of products including publications, conferences, databases and reports, Elsevier Business Intelligence places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge, by providing a combination of news and information together with penetrating insight and analysis.
Organized by Elsevier Business Intelligence, the 2013 Therapeutic Area Partnerships (TAP) conference is designed to bring together biopharmaceutical industry decision makers to assess the most promising drug programs available for partnering in the following therapeutic areas: oncology, cardiovascular/metabolic diseases, neuroscience, infectious diseases, anti-inflammatory/autoimmune diseases and advanced therapies. For more information, please visit the conference website at http://www.elsevierbi.com/mkt/Conf/TAP2013/PresentingCos.
This press release contains forward-looking statements, including statements regarding clinical trial activities, the publication of data, and the potential application of the Company’s technologies and product candidates in the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.
1. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N
Engl J Med, 2005. 352(10): p. 987-96.
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Jonae R. Barnes, 617-818-2985
Investor Relations and Corporate Communications