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.”

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