Advaxis Submits INDA For Phase 1/2 Study Of ADXS-HPV And MedImmune's MEDI4736

(RTTNews) - Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, said the company has submitted an Investigational New Drug application to the United States Food and Drug Administration to conduct a Phase 1/2 study of ADXS-HPV or ADXS11-001 alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736.

This is for the treatment of advanced, recurrent or refractory human papillomavirus or HPV-associated cervical cancer and HPV-associated head and neck cancer.

ADXS-HPV is Advaxis's lead Lm-LLO immunotherapy designed for the treatment of HPV-associated cancers. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can increase overall anti-tumour response.

The proposed Phase 1/2 protocol is designed to evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with MEDI4736.

Specifically, the Phase 1 part of the trial is expected to establish a recommended dose regimen of ADXS-HPV with MEDI4736, and the Phase 2 portion will assess the safety and efficacy of the combination. The study is planned to begin in early 2015.