Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced their combination study with MedImmune, the global biologics research and development arm of AstraZeneca, has completed the first dose-escalation cohort in a study evaluating axalimogene filolisbac (AXAL) in combination with durvalumab and has commenced the second dose-escalation cohort.
The study is evaluating the safety and efficacy of AXAL, Advaxis’ lead immunotherapy candidate, in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
“I am proud that we have reached this stage because combination therapies hold great potential for cancer patients,” said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. “This trial is exploring how we can harness the power of immuno-oncology to block anti-tumor T-cell immunity and simultaneously target HPV-associated cancers. It is these kinds of combination therapies that may dramatically change the course of how we treat cancer.”
The first dose-escalation cohort evaluated AXAL at 1×109 cfu with 3mg/kg durvalumab and the second dose-escalation cohort will now examine AXAL at 1×109 cfu in combination with 10mg/kg durvalumab. Upon completion of dose escalation, the Phase II study will randomize 90 patients to receive AXAL in combination with durvalumab vs. durvalumab alone. The primary efficacy endpoints include objective response rate and progression-free survival.
The companies plan to submit an abstract to a major medical meeting on the dose-escalation portion of the study in the second half of the year. Further information about the Phase I/II study can be found on ClinicalTrials.gov, using Identifier NCT02291055. (Original Source)
Shares of Advaxis Inc closed yesterday at $8.35, down $0.39 or -4.46%. 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 $7.23 and its 200-day moving average is $10.12.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on March 7, FBR analyst Vernon Bernardino maintained a Buy rating on ADXS. 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 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 -25.9% and -23.9% respectively. Bernardino has a success rate of 24.5% and is ranked #3733 out of 3749 analysts, while Ramakanth has a success rate of 23.7% and is ranked #3718.
Advaxis Inc is a clinical development stage biotechnology company. The Company is engaged in discovery, development and commercialization of Lm-LLO immunotherapies for cancer and infectious diseases.