Advaxis submits IND for Phase I/II trial of ADXS-HPV and MEDI4736 in HPV-associated cancers

Following approval for the IND application, the company will conduct a Phase I/II trial of ADXS-HPV alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, to treat advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Scheduled to start in early 2015, the trial will evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with MEDI4736.

The Phase I part of the trial is expected to establish a recommended dose regimen of ADXS-HPV with MEDI4736, while the Phase II portion will evaluate the safety and efficacy of the combination.

Advaxis president and chief executive officer Daniel O’Connor said: "Additionally, the filing of this IND and the recently announced filing of the ADXS-PSA + KEYTRUDA (pembrolizumab) IND demonstrate Advaxis’s ability to rapidly transition partnering agreements to clinical programs.

"Since announcing our agreements with MedImmune and Merck in July and August, respectively, we have worked diligently with both companies’ research teams to develop IND filings involving each company’s checkpoint inhibitor that, upon acceptance by FDA, should enable us to initiate two Phase I/II trials in early 2015."

In July 2014, Advaxis entered into clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca.

According to preclinical evidence, the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can improve overall anti-tumor response.

Image: The combination drug of ADXS-HPV and MEDI4736 will be used to treat human papillomavirus (HPV) associated cancers. Photo: courtesy of renjith Krishnan/ freedigitalphotos.net.