Advaxis, a Princeton, N.J.-based clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Incyte to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-HPV (ADXS11-001), with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360). Incyte is a pharmaceutical company based in Alapocas, Del.

The phase II, multicenter, open-label, preoperative window-study will evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with epacadostat in approximately 20 patients with stage I-IIa human papillomavirus (HPV)-associated cervical cancer. Both ADXS-HPV and epacadostat are investigational cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer.

Daniel J. O'Connor, CEO of Advaxis, said, "In previous and ongoing studies, a single treatment cycle of ADXS-HPV, as a monotherapy, has demonstrated improvements in overall survival in women with recurrent cervical cancer. We believe the combination of immunotherapies may hold significant promise for the treatment of this difficult-to-treat disease."

Advaxis and Incyte will collaborate on a non-exclusive basis to evaluate the combination of ADXS-HPV with epacadostat for the treatment of cervical cancer. The companies will collaboratively conduct and fund the study, which is expected to begin later this year. Results from the study will be used to determine whether further clinical development of this combination is warranted. Further details of the agreement have not been disclosed.

"We believe immune-targeted combination therapy represents a promising new approach in oncology," said Rich Levy, M.D., chief drug development and medical officer at Incyte. "This clinical trial collaboration is a further illustration of our desire to investigate the therapeutic value of our IDO1 inhibitor in multiple tumor types as rapidly as possible."

There are 500,000 new cases of cervical cancer caused by HPV worldwide every year, according to the WHOHuman Papillomavirus and Related Cancers in the World Summary Report2010. Current preventative vaccines cannot protect the 20 million women who already are infected with HPV; of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines. Challenges with acceptance, accessibility, and compliance have resulted in only about a third of young women being fully vaccinated in the U.S. and even less in other countries around the world. HPV is associated with 20-50% of oral squamous cell carcinomas.