Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced two research projects involving the company’s LmTechnology(TM) immunotherapy candidate ADXS-PSA, which is being developed for prostate cancer, have been selected as 2015 Movember Foundation-PCF Challenge Awards, sponsored by the Movember Foundation and the Prostate Cancer Foundation (PCF). Grants amounting to $1 million each have been awarded to two ADXS-PSA teams conducting innovative large-scale research projects concerning metastatic, treatment-resistant prostate cancer, an advanced form of the disease with often-lethal outcomes.
The Movember Foundation-PCF Challenge Awards support cross-disciplinary teams of investigators conducting pioneering research to address critical, unmet medical needs for prostate cancer patients. These highly competitive awards make large investments in multi-year projects that may fall outside the parameters of traditional funding organizations. Each proposal submitted to PCF was subjected to a rigorous peer review process that assessed the scientific merit of the project as well as its potential impact for patients. To date, the Movember Foundation has donated approximately $39 million to PCF to support innovative prostate cancer research, funding 28 research awards in the U.S., Canada and Great Britain.
Both ADXS-PSA projects awarded involve principal investigator Adam P. Dicker, M.D., Ph.D., Chair of the Department of Radiation Oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University, and will evaluate progression-free survival (PFS) as the primary endpoint and look at deep sequencing of T cell receptors to follow expansion of specific T cell clones.
“I look forward to having the opportunity to explore the potential of ADXS-PSA as immunotherapy in locally advanced and metastatic prostate cancer in two clinical trials,” said Dr. Dicker. “These trials will help further the scientific understanding on the effects of targeting the prostate-specific antigen associated with prostate cancer.”
The following ADXS-PSA proposals were selected to receive funding:
- The first proposal, “CARAVAN (Checkpoint-Radiation-Vaccine Neoadjuvant) trial for metastatic prostate cancer,” is led by researchers at the Sidney Kimmel Cancer Center at Thomas Jefferson University (Adam P. Dicker, M.D., Ph.D.) and the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center (Lawrence Fong, M.D.). This is a Phase 1/2 study investigating intraprostatic anti-CTLA-4 and PD-1 blockade, plus radiation and ADXS-PSA in metastatic prostate cancer (N= ~42 +/-, its variable).
- The second proposal, “Altering the natural history of metastatic prostate cancer using stereotactic ablative radiotherapy and immune stimulation,” is led by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (Phuoc T. Tran, M.D., Ph.D. and Ashley Ross, M.D., Ph.D.) and Sidney Kimmel Cancer Center at Thomas Jefferson University (Adam P. Dicker, M.D., Ph.D.). This is a Phase 1/2 study that combines stereotactic ablative radiation to prostate cancer metastases, followed by treatment with ADXS-PSA (N= ~36).
“We are tremendously honored to have ADXS-PSA recognized and supported in this way by the 2015 Movember Foundation-PCF Challenge Awards,” said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. “This funding will bring about the research necessary to potentially bring ADXS-PSA immunotherapy to people with metastatic prostate cancer, a disease that is expected to take the lives of 27,540 men in 2015.”
Advaxis recently announced that enrollment has initiated in the Phase 1/2 KEYNOTE-046 clinical trial evaluating the combination of ADXS-PSA and Merck’s anti-PD-1 therapy KEYTRUDA(R)(pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). KEYNOTE-046 is the first-in-human study of ADXS-PSA and the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. Data from preclinical studies suggest that Advaxis’s Lm Technology(TM) immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response.
About the Prostate Cancer Foundation
The Prostate Cancer Foundation (PCF) is the world’s leading philanthropic organization funding and accelerating prostate cancer research. Founded in 1993, PCF has raised more than $615 million and provided funding to more than 2,000 research programs at nearly 200 cancer centers and universities. The PCF global research enterprise now extends to 19 countries. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds for transformational cancer research. Its efforts have helped produce a 20-fold increase in government funding for prostate cancer. For more information,click here.
The Movember Foundation is a global charity raising funds and awareness for men’s health. These funds deliver breakthrough research and support services to allow men to live longer, healthier, happier lives. Since 2003, millions have joined the men’s health movement, raising more than $650 million and funding over 1,000 programs through impact investments, focusing on prostate cancer, testicular cancer and poor mental health.
The Foundation runs awareness and fundraising activities year-round, with the annual Movember campaign in November being globally recognized for its fun and innovative approach to raising money and getting men to take action for their health. During Movember, we challenge men to grow a moustache or to make a commitment to get active and MOVE, both of which are about real action for health and are done to spark conversation and raise vital funds and awareness. The Foundation’s vision is to have an everlasting impact on men’s health.
Movember is fully accredited by the Better Business Bureau, and for the past three years, has been named a Top 100 best NGO by The Global Journal. For more information please visitMovember.com. Movember is a registered 501(c)(3) charity.
About the KEYNOTE-046 Trial
KEYNOTE-046 is a multicenter, dose determining, open-label Phase 1/2 study designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA in approximately 51 mCRPC patients. Part A of the study will be a dose escalating study designed to establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B will consist of a dose escalating trial of ADXS-PSA in combination with KEYTRUDA, followed by an expansion cohort phase. The primary objective is to evaluate safety and tolerability of the two immunotherapies, with the secondary objective to evaluate anti-tumor activity and PFS. Further information about KEYNOTE-046 can be found on ClinicalTrials.gov, using Identifier NCT02325557.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men are expected to die of the disease in 2015.
ADXS-PSA is an Lm Technology(TM) immunotherapy that is designed to target the prostate-specific antigen (PSA), a protein produced exclusively by prostate cells that is associated with prostate cancer. ADXS-PSA secretes the PSA antigen, fused to the powerful immunostimulant tLLO, directly inside the antigen presenting cells that are capable of driving a cellular immune response to PSA expressing cells. This approach is also designed to inhibit the Treg and myeloid-derived suppressor cells (MDSCs) that contribute to immunologic tolerance of prostate cancer. In preclinical analysis, ADXS-PSA inhibits the immunosuppression caused by Treg and MDSC cells localized inside tumors that may promote immunologic tolerance of prostate cancer.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology(TM). The LmTechnology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm Technology immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted Advaxis orphan drug designation for each of these three indications. For additional information on Advaxis, visitwww.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS-PSA. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
KEYTRUDA is a registered trademark of Merck & Co., Inc.