FDA Clears ADXS-HPV For Phase 2 Trial In HPV-Associated Early Stage Cervical Cancer

FDA Clears ADXS-HPV For Phase 2 Trial In HPV-Associated Early Stage Cervical Cancer

Advaxis, Inc. recently announced that the FDA authorized a Investigational New Drug (IND) application for its Phase 2 study evaluating the efficacy of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corporation’s investigational oral IDO1 inhibitor, epacadostat, as a therapy for Stage I-IIIb human papillomavirus (HPV)-related with cervical cancer.

Incyte Corporation is a company focused on the development, discovery and commercialization of proprietary drugs for oncology and recently signed an agreement to assess the efficacy of ADXS-HPV with epacadostat for cervical cancer.

Epacadostat is an orally bioavailable small molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1) with nanomolar potency in both biochemical and cellular assays. ADXS-HPV is Advaxis’s lead candidate product for the treatment of HPV-associated cancers.

The phase 2 trial will be an open-label, multicenter, preoperative window-study to assess the efficacy and safety of ADXS-HPV alone or in combination with epacadostat in approximately 30 patients with Stage I-IIIb human papillomavirus (HPV)-related cervical cancer.  Results from this trial will determine if the compound can be used as a treatment for the condition.

“The FDA clearance of the ADXS-HPV plus epacadostat IND for HPV-associated early stage cervical cancer adds to Advaxis’s rapidly advancing pipeline in cervical cancer,” stated in a recent press release Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “Additionally, the acceptance of this IND strengthens our pipeline of combination studies involving our Lm-LLO platform and aligns our technology with another potentially best-in-class immunotherapy technology.  We look forward to the initiation of this study with Incyte.”

“We are very pleased that the IND for this Phase 2 study has been cleared by the FDA,” added Rich Levy, MD, Chief Drug Development Officer at Incyte. “Epacadostat is currently in multiple combination proof-of-concept trials with immune checkpoint inhibitors, and this new study may provide us with important translational data for epacadostat in combination with an immunotherapeutic vaccine.”

Average Rating
No rating yet

Leave a Comment

Your email address will not be published.