Advaxis Reports FDA Grant Award For Phase 2 Study Of Axalimogene Filolisbac

(RTTNews) - Advaxis, Inc.( ADXSW, ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, Monday announced that the U.S. Food and Drug Administration's Office of Orphan Products Development 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 Lm Technology immunotherapy, axalimogene filolisbac or ADXS-HPV, in HPV-associated oropharynx 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 10 to 15 applications are selected for funding each fiscal year.

The Phase 2 study will be led by Andrew Sikora, 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.

It is supported by key investigators Brett Miles, and Marshall Posner, 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.