Published On: Sun, Jul 15th, 2018

FDA lifts clinical hold on Advaxis’ Axalimogene Filolisbac, Durvalumab combo trial

Tagged with: | | | | | | | |

Advaxis revealed that the () has removed a previously imposed clinical hold on its Phase 1/2 trial of Axalimogene Filolisbac (AXAL) and Durvalumab combination.

The early-stage trial by the New Jersey-based biotech company was assessing the drug combo for the of advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

In March 2018, the FDA placed a clinical hold on the investigational new drug (IND) application for the trial following the death of a patient, who was dosed with Axalimogene Filolisbac/ Durvalumab. The patient’s death involved acute respiratory failure after being subjected to nine months of the combination therapy, said Advaxis.

The biotech company said that new guidelines for the early detection and treatment of such rare incidents were agreed to with the FDA and will be put into place in the combination study.

FDA lifts clinical hold on Advaxis’ Axalimogene Filolisbac, Durvalumab combo trial

FDA lifts clinical hold on Advaxis’ Axalimogene Filolisbac, Durvalumab combo trial. Photo courtesy of Stuart Miles at FreeDigitalPhotos.net.

Advaxis revealed that enrollment and dosing in all other Advaxis and durvalumab clinical trials were not impacted by the clinical hold.

Kenneth A. – President and CEO of Advaxis, said: “We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis’ portfolio as needed, to ensure patient safety.

“We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1200 doses across multiple trials in HPV-associated .”

According to Advaxis, Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy. The Advaxis cancer drug candidate has been designed to attack HPV-associated cancers by modifying a live strain of Lm bacteria to generate cancer-fighting T cells to take on cancer antigens. Axalimogene Filolisbac is also said to be designed to neutralize the tumor’s natural protections that shield the tumor microenvironment from immunologic attack.

Related posts