Amgen Forges Pre-clinical R&D Pact Worth $540 Million With Advaxis

Published: Aug 04, 2016

Amgen Forges Pre-clinical R&D Pact Worth $540 Million With Advaxis August 2, 2016
By Alex Keown, Breaking News Staff

THOUSAND OAKS, Calif. – California-based 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.

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.

"Amgen is a pioneer in the science of using living cells to develop biologic medicines, making them an incredibly strong partner to develop and commercialize Advaxis' MINE," Daniel O'Connor, president and chief executive officer at Advaxis, said in a statement.

Amgen will make a $40 million upfront payment and purchase $25 million of Advaxis common stock. Under additional terms, Amgen will be responsible for funding clinical and commercial activities, While Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept. Advaxis will receive the additional potential $475 million as milestone payments, the companies jointly announced this morning.

Following the announcement of the collaborative deal this morning, shares of Advaxis jumped more than 25 percent, leaping from $8.47 per share at closing Monday to $10.74 per share this morning. Shares of Amgen, on the other hand, are down slightly this morning.

The deal with Amgen can give Advaxis a shot in the arm 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. It was ultimately ruled, as Advaxis maintained, that the severity of the patient’s cancer was to blame and not any reaction to the treatment. The drug has since moved into mid-stage trials. Axalimogene filolisbac is being developed to treat patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. Phase I trials released at the end of September 2015 showed treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients. Patients typically fighting PRmCC who have failed at least one line of therapy have a typical survival rate of four to seven months.

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