Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and MedImmune, the global biologics research and development arm of AstraZeneca, today announced that enrollment has commenced in a Phase I/II clinical trial of axalimogene filolisbac (ADXS-HPV), Advaxis’s investigational Lm Technology™ immunotherapy, in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
The two-part, open-label Phase I/II study is designed to evaluate the safety and efficacy of axalimogene filolisbac as a monotherapy and in combination with durvalumab in approximately 66 patients. Phase I is a dose-confirmation combination study with axalimogene filolisbac and durvalumab, which is expected to establish the maximum tolerated dose. The Phase II portion of the study will randomize patients to receive axalimogene filolisbac monotherapy, durvalumab monotherapy, or the combination. The primary efficacy endpoints include objective response rate and progression-free survival. Further information about the Phase I/II study can be found onClinicalTrials.gov, using Identifier NCT02291055.
“We are pleased to have initiated patient enrollment for this combination immunotherapy study and look forward to evaluating this immunotherapy combination in the clinic, with the hopes of confirming the preclinical anti-tumor effects,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “The initiation of our combination immunotherapy study with MedImmune adds to what has become a rapidly expanding clinical development pipeline for Advaxis involving our Lm Technology™ immunotherapy platform alone and in combination with potentially synergistic technologies.”
Axalimogene filolisbac and durvalumab are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body’s own defenses in fighting cancer. Data from preclinical studies suggest that Advaxis’s Lm Technology™ immunotherapies in combination with a checkpoint inhibitor, such as durvalumab, may lead to an enhanced anti-tumor immune response. Results from the Phase I/II study will determine the future clinical development program for the combination. (Original Source)
Shares of Advaxis closed yesterday at $14.89. 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 $17.13 and its 200-day moving average is $16.92.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on August 7, MLV & Co. analyst Vernon Bernardino initiated coverage with a Buy rating on ADXS and a price target of $34, which implies an upside of 128.3% from current levels. Separately, on June 26, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $30.
According to TipRanks.com, 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 -16.0% and -2.5% respectively. Bernardino has a success rate of 23.4% and is ranked #3708 out of 3741 analysts, while Ramakanth has a success rate of 27.7% and is ranked #3092.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.