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Amgen, Advaxis Partner on Personal Cancer Immunotherapy

Listeria monocytogenes bacteria

Listeria monocytogenes bacteria (Nathan Reading, Wikimedia Commons)

2 August 2016. Biological drug maker Amgen is licensing precision immunotherapy technology from Advaxis Inc. to develop treatments for cancer. The deal could bring Advaxis, a biotechnology company in Princeton, New Jersey, as much as $540 million if all parts of the agreement are exercised.

Advaxis develops immunotherapies for cancer from weakened Listeria monocytogenes or Lm bacteria, associated by most people with food poisoning. The bacteria are engineered to include a form of listeriolysin O, a protein that enhances their ability to penetrate cell membranes, in this case tumor cells.

Once inside the tumor cells, the listeriolysin O proteins make cancer cells, which normally hide from the immune system, look like bacteria and generate a response from T-cells in the immune system. In addition, the engineered proteins break down myeloid-derived suppressor and regulatory T-cells that protect the immediate tumor environment.

The agreement gives Amgen an exclusive worldwide license to develop and commercialize an advanced extension of the Advaxis Lm technology, known as My Immunotherapy Neo-Epitopes, or Mine. With Mine, DNA is extracted and sequenced from the patient’s primary tumor or metastatic cancer cells to identify epitopes, binding locations on neoantigens, which are recently formed and not yet recognized by the immune system. These neoepitopes in cancer cells, derived from DNA sequenced from the patient, then become the targets for activated immune system T-cells.

Under the agreement, Advaxis will lead initial research and development of Mine through proof-of-concept, and retain responsibility for manufacturing. Amgen will be responsible for clinical development and commercialization. Clinical trials are expected to begin in 2017.

The deal also calls for Amgen to make an initial payment of $40 million and take an equity stake in Advaxis of $25 million in common stock. Advaxis will also be eligible for development, regulatory, and sales milestone payments of up to $475 million, as well as royalties on product sales.

Amgen is a biotechnology enterprise developing original biological-based treatments as well as biosimilars. The Thousand Oaks, California company has a number of new therapies for cancer in its pipeline currently in clinical trials.

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