Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced two research projects involving the company’sLm Technology™ 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® (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™ immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. (Original Source)
Shares of Advaxis Inc closed yesterday at $15.35. ADXS has a 1-year high of $30.13 and a 1-year low of $2.50. The stock’s 50-day moving average is $18.56 and its 200-day moving average is $16.52.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on June 26, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which implies an upside of 95.4% from current levels. Separately, on June 25, MLV & Co.’s Ram Selvaraju reiterated a Buy rating on the stock and has a price target of $34.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Ram Selvaraju have a total average return of 11.1% and 9.7% respectively. Ramakanth has a success rate of 39.1% and is ranked #853 out of 3724 analysts, while Selvaraju has a success rate of 47.1% and is ranked #500.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.