Company Update (NASDAQ:ADXS): FDA Awards Grant for Phase 2 Study of Advaxis, Inc.’s Axalimogene Filolisbac in HPV-Associated Head and Neck Cancer

Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) awarded a grant totaling $1.1 million over three years to Baylor College of Medicine in support of an ongoing Phase 2 trial of Advaxis’s lead LmTechnology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer.

The grant was administered through the FDA’s Orphan Products Grants Program, created more than 30 years ago by the Orphan Drug Act to promote the development of products for rare diseases. It is a competitive program that receives approximately 100 applications per year, from which typically 10 to 15 applications are selected for funding each fiscal year.

“Applications to the Orphan Products Grants Program undergo rigorous review for scientific and technical merit by a panel of experts to compete for funding,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “We are encouraged to see axalimogene filolisbac recognized as viable by being awarded a grant for its clinical research that could ultimately contribute to market approval.”

The Phase 2 study will be led by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology at BCM and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor, and is supported by key investigators Brett Miles, M.D. and Marshall Posner, M.D. at the Icahn School of Medicine at Mount Sinai. The study is designed to evaluate the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated oropharyngeal cancer.

“We hope to improve outcomes in HPV-associated head and neck cancer by exploring axalimogene filolisbac in this indication, where existing treatment options are associated with risk of long-term morbidity,” said Dr. Sikora. “If successful, this trial could pave the way for immunotherapy to become a standard treatment for HPV-associated cancers.” (Original Source)

Shares of Advaxis closed last Friday at $16.51. 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 $15.13 and its 200-day moving average is $17.71.

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 105.9% 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, 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 -13.4% and -1.5% respectively. Bernardino has a success rate of 24.7% and is ranked #3707 out of 3755 analysts, while Ramakanth has a success rate of 29.2% and is ranked #2893.

Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.

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