Advaxis, Incyte enter clinical trial collaboration for cervical cancer drug

ADXS-HPV is Advaxis’s investigational Lm-LLO immunotherapy designed to treat human papillomavirus (HPV)-associated cancers, while epacadostat is Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor.

As part of the deal, a multicenter, open-label, preoperative window Phase II trial will be conducted to evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with epacadostat in around 20 patients with Stage I-IIa HPV-associated cervical cancer.

Both the cancer immunotherapies, ADXS-HPV and epacadostat are a new class of treatments that use the body’s own immune system to combat cancer.

Advaxis chief executive officer Daniel O’Connor said: "We are excited to collaborate with Incyte and to evaluate epacadostat in combination with our leading Lm-LLO immunotherapy candidate, ADXS-HPV.

"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."

The deal will see the two firms collaboratively conduct and fund the Phase II trial, which is expected to be initiated later in 2015.

Results from the trial will be used to determine whether further clinical development of this combination is warranted.

Incyte chief drug development and medical officer Rich Levy said: "We believe immune-targeted combination therapy represents a promising new approach in oncology.

"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."