Advaxis' Resurrection and the Man Behind It All
August 23, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PRINCETON, N.J. – A lucrative deal with Amgen , a fast track designation from the U.S. Food and Drug Administration for a cancer drug and a new(ish) chief executive officer are reasons Advaxis has risen from the ashes.
Earlier this month, Amgen struck a research and development deal with New Jersey-based Advaxis, Inc. for the development of that company’s pre-clinical immunotherapy treatment, ADXS-NEO. The partnership, which is potentially worth about $540 million, is expected to leverage Amgen’s “development expertise in immuno-oncology” with Advaxis’ MINE (My Immunotherapy Neo-Epitopes) program. The MINE Program is designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes as Advaxis calls them, contained in each individual patient's tumor.
That Amgen deal was a shot in the arm for Advaxis, which had been floundering following concerns raised due to a death in a clinical trial last year. There were questions about a patient death in the early-stage trial of experimental cancer treatment axalimogene filolisbac. As a result, the U.S. Food and Drug Administration placed four trials on clinical hold until the death could be investigated. The FDA ultimately ruled, as Advaxis maintained, that the severity of the patient’s cancer was to blame and not any reaction to the treatment and the drug was since moved into mid-stage trials.
Additionally, a CEO who has been on the job for three years, has been able to provide needed guidance to the company that was on the brink of shutting down. Daniel O’Connor was tapped to helm the company and turn it around. In an interview with StatNews, O’Connor said he believed the company’s engineered listeria monocytogene program was sound and deserved a chance. O’Connor brought to Advaxis the same tenacity he used to turnaround ImClone following an insider trading scandal. O’Connor was able to provide that company with the steady hand to guide its cancer drug, Erbitux, to market in 2006 following the scandal, StatNews said.
The Advaxis Lm Technology uses live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. In the ADXS-NEW program, DNA from each patient's primary tumor and/or metastases as well as normal cells, is sequenced and compared to identify mutations in genes coding for potential neo-antigens in the cancer, the company said. From there, the company engineers “patient-specific Lm-LLO (listeriolysin O) vectors capable of immunizing them against neoepitopes exclusive to their cancer.” Clinical trials for ADXS-NEO are expected to begin in 2017.
Earlier this month, Advaxis announced its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC) met it’s the first stage of its Phase II primary objective and is advancing into the second stage of the clinical study. The clinical study is designed to show that AXAL is highly immunogenic and worth further investigation if the overall rate of vaccine-induced T-cell responses is 75 percent or more. In July, AXAL received Fast Track Designation for high risk cervical cancer patients.