Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (NYSE:MRK), announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

The KEYNOTE-046 trial 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.

“We are one step closer to evaluating our Lm platform in combination with a PD-1 antibody and are excited to launch this next cohort,” said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. “We are thrilled to continue our collaboration with Merck in pursuit of finding a treatment option for a form of prostate cancer where few options exist.”

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 51 mCRPC patients. Part A of the study is a dose escalating study designed to establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B of the study will commence mid-year and evaluate ADXS-PSA in combination with KEYTRUDA, followed by an expansion cohort phase. The primary objective is to evaluate the safety and tolerability of the two immunotherapies, with the secondary objective to evaluate anti-tumor activity and progression-free survival.(Original Source)

Shares of Advaxis closed yesterday at $9.28, up $0.02 or 0.22%. ADXS has a 1-year high of $30.13 and a 1-year low of $5.21. The stock’s 50-day moving average is $7.72 and its 200-day moving average is $9.77.

On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on March 29, FBR analyst Vernon Bernardino reiterated a Buy rating on ADXS, with a price target of $34, which represents a potential upside of 266.4% from where the stock is currently trading. Separately, on March 2, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $23.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Swayampakula Ramakanth have a total average return of -18.7% and -20.4% respectively. Bernardino has a success rate of 32.4% and is ranked #3747 out of 3777 analysts, while Ramakanth has a success rate of 26.9% and is ranked #3738.

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. Advaxis was founded on June 5, 1987 and is headquartered in Princeton, NJ.