- Shares up 38%+ in pre-market trading
- Clinical Hold was issued on March 9, 2018
- Axalimogene filolisbac has fast track designation for adjuvant therapy for high-risk locally advanced cervical cancer
Advaxis, Inc. (NASDAQ:ADXS)announced on 7/13/2018 that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s Investigational New Drug (IND) application for its Phase 1/2 study of axalimogene filolisbac (AXAL) in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.
The clinical hold for this study was issued on March 9, 2018 following submission by the Company of a safety report to the FDA regarding a patient death that occurred on February 27, 2018, post-dosing, involving acute respiratory failure after nine months of combination therapy. New guidelines for the early detection and treatment of such rare events were agreed to with the FDA and will be implemented for this combination study. Enrollment and dosing in all other Advaxis and durvalumab clinical programs were not affected by the clinical hold.
“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 cancers,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis.
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38% in 50 patients. This is a 52% improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.
Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.
As of this writing, shares are up more than 38% in pre-market trading.