13 March 2018 - - The US Food and Drug Administration has notified Princeton New Jersey-based immunotherapy developer Advaxis, Inc. (NASDAQ: ADXS) that its investigational new drug application for its Phase 1/2 combination study of axalimogene filolisbac with Imfinzi (durvalumab) for the treatment of patients with advanced, recurrent, or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer was placed on clinical hold, the company said.
The clinical hold pertains to a recent submission of a safety report to the FDA regarding a Grade 5 Serious Adverse Event (patient death) on February 27, 2018 involving respiratory failure which occurred following the sixth combination cycle in the trial.
Enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator to review this event in detail and to resolve this clinical hold.
Enrollment and dosing in all other Advaxis clinical programmes are unaffected at this time.
Advaxis is focused on the discovery, development, and commercialization of proprietary Lm-based antigen delivery products based on a platform technology that utilises live attenuated Listeria monocytogenes bioengineered to secrete antigen/adjuvant fusion proteins.
These Lm-based strains integrate multiple functions into a single immunotherapy.
The company has four franchises in various stages of clinical and pre-clinical development: HPV-associated cancers, prostate cancer, neoantigen therapy, and hotspot mutation therapy.