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

Advaxis, a biotech firm based in New Jersey, announced a significant regulatory update as the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on its Phase 1/2 trial. This trial is exploring the effectiveness of a combination therapy using Axalimogene Filolisbac (AXAL) and Durvalumab in treating advanced, recurrent, or refractory cervical cancer and HPV-associated head and neck cancer.

The FDA’s decision to pause the trial in March 2018 followed the unfortunate death of a patient from acute respiratory failure after nine months of receiving the combination therapy. This incident prompted a thorough investigation and the implementation of new guidelines aimed at the early detection and management of such rare events, which Advaxis has agreed to adopt.

In light of the FDA’s decision, Advaxis has committed to enhancing patient safety protocols across all ongoing clinical trials involving AXAL and Durvalumab. Kenneth A. Berlin, President and CEO of Advaxis, expressed relief and optimism about the resolution with the FDA, stating, “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.”

Berlin also reaffirmed confidence in the safety of Axalimogene Filolisbac, citing extensive experience with approximately 400 patients and over 1200 doses administered in various trials targeting HPV-associated cancers.

Axalimogene Filolisbac is a targeted immunotherapy developed by Advaxis, utilizing a modified Listeria monocytogenes (Lm) strain. This innovative approach aims to stimulate the body’s immune system to generate cancer-fighting T cells and neutralize the tumor’s natural defenses. By doing so, it allows for a more effective immunologic attack on cancer cells.

The lifting of the clinical hold marks a pivotal moment for Advaxis as it continues to explore the potential of its innovative cancer therapies. The ongoing trial will provide valuable data on the efficacy and safety of the Axalimogene Filolisbac and Durvalumab combination, offering hope for patients with difficult-to-treat HPV-associated cancers.

The resumption of the Axalimogene Filolisbac and Durvalumab trial is a crucial development in the field of cancer immunotherapy. It highlights the challenges and complexities of developing new cancer treatments but also underscores the potential for significant advancements in treating cancers with high unmet medical needs.