Amgen will develop and commercialize Advaxis’ ADXS-NEO, a novel, preclinical cancer immunotherapy candidate, through a global agreement that could generate more than $540 million for Advaxis, the companies said today.

ADXS-NEO is designed to activate a patient's immune system to respond against the neoepitopes contained in and identified from each individual patient's tumor. The collaboration is designed to combine Amgen's development expertise in immuno-oncology with Advaxis' MINE™ (My Immunotherapy Neo-Epitopes) program.

MINE™ will evaluate the immunologic and antitumor activity of ADXS-NEO. Advaxis and Amgen said they plan to use insights gleaned from MINE to identify and target neoepitopes using Lm Technology™, which 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.

The companies plan to develop patient-specific immunotherapy constructs that incorporate the neoepitope sequences identified in the patient's tumor cells. Clinical studies using ADXS-NEO are in development and expected to begin in 2017.

Amgen will receive exclusive worldwide rights to develop and commercialize ADXS-NEO. In return, Amgen agreed to pay Advaxis $40 million upfront, as well as purchase $25 million of Advaxis common stock.

Amgen also agreed to pay Advaxis development, regulatory, and sales milestone payments of up to $475 million, as well as potential high-single-digit to mid-double digit royalty payments based on worldwide sales.

Amgen has agreed to oversee fully funding clinical and commercial activities. Advaxis will lead clinical development of ADXS-NEO through proof-of-concept and retain manufacturing responsibilities.

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