Advaxis Forms Clinical Trial Collaboration With Incyte to Evaluate Investigational Combination of Two Novel Cancer Immunotherapies for Early Stage Cervical Cancer

On February 11, 2015 Advaxis reported that it 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) (Press release Advaxis, FEB 11, 2015, View Source [SID:1234501537]). The Phase 2 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.

“We are excited to collaborate with Incyte and to evaluate epacadostat in combination with our leading Lm-LLO immunotherapy candidate, ADXS-HPV,” said Daniel J. O’Connor, Chief Executive Officer of Advaxis. “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.”

Under the terms of the agreement, 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 were not disclosed.

“We believe immune-targeted combination therapy represents a promising new approach in oncology,” said Rich Levy, MD, 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.”