Advaxis, Inc. (NASDAQ:ADXS) announced the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis’ Lmimmunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). In Part A of the Phase 1/2 study, 14 patients were treated with ADXS-PSA monotherapy across three dose levels, with no dose limiting toxicities, paving the way for initiating Part B of the study.
KEYNOTE-046 is a multicenter, open-label, nonrandomized, dose determining, Phase 1/2 trial evaluating the safety of ADXS-PSA. Part B of the study is evaluating the tolerability of ADXS-PSA in combination with KEYTRUDA in 30 patients with mCRPC. Secondary objectives for this study are to evaluate antitumor activity and progression-free survival of ADXS-PSA. KEYNOTE-046 is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.
Advaxis also announced initiation of its Phase 3 AIM2CERV study, a multicenter, placebo-controlled, randomized study of axalimogene filolisbac, or AXAL, administered in the adjuvant setting following chemotherapy and radiation in women with high-risk, locally advanced cervical cancer (HRLACC). The primary objective of the trial is disease-free survival, with secondary objectives including examining overall survival and safety. In July 2016, Advaxis received a Special Protocol Assessment for the AIM2CERV trial, as well as Fast Track designation for AXAL as an adjuvant therapy for HRLACC patients. (Original Source)
Shares of Advaxis are up nearly 2% to $9.00 in pre-market trading Thursday. ADXS has a 1-year high of $16.30 and a 1-year low of $5.21. The stock’s 50-day moving average is $10.66 and its 200-day moving average is $9.75.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on September 8, Jefferies analyst Biren Amin reiterated a Buy rating on ADXS, with a price target of $24, which represents a potential upside of 172% from where the stock is currently trading. Separately, on August 3, Barclays’ Jonathan Eckard reiterated a Buy rating on the stock and has a price target of $20.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Jonathan Eckard have a total average return of 8.5% and -5.9% respectively. Amin has a success rate of 53% and is ranked #358 out of 4180 analysts, while Eckard has a success rate of 35% and is ranked #3707.
Advaxis, Inc. is a clinical-stage biotechnology company, which intends to develop immunotherapies for cancer and infectious diseases. The company’s platform technology is designed to generate a comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor.