ONO Announces Expanded Collaboration with Fate Therapeutics on iPSC-derived CAR-T Cell and CAR-NK Cell Therapies for Solid Tumors

 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director and CEO, Gyo Sagara; “ONO”) announced that it has entered into an agreement to expand the drug discovery collaboration with Fate Therapeutics, Inc. (San Diego, CA, USA; President and CEO, Scott Wolchko; “Fate”) for the discovery of iPSC-derived chimeric antigen receptor (CAR) -T cell therapies originally entered into in September 2018.

 With this agreement, the discovery of iPSC-derived CAR-NK cell therapy will be added to iPSC-derived CAR-T cells therapy for solid tumors. And further, a second new target for solid tumor collaboration has been added and ONO will provide Fate with antibodies that bind to the target.

 Fate will continue to receive research funding from ONO and advance iPSC-derived CAR-T and CAR-NK cell product candidates to a pre-defined preclinical milestone, at which point ONO has an option to assume responsibility for worldwide development and commercialization with Fate retaining the right to jointly develop and commercialize in the United States and Europe. ONO will also pay to Fate milestone payments on progress of clinical development stages, and on the achievement of certain net sales threshold as well as tiered royalties on annual net sales by ONO. Fate retains all rights of manufacture of collaboration products on a global basis.

 “The first multiplexed-engineered, iPSC-derived CAR-T cell product candidate under our collaboration with Fate Therapeutics incorporates multiple mechanisms of action designed to specifically address solid tumors and is successfully advancing toward clinical development,” said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of ONO. “Based on the collaboration progress and Fate’s proven ability to develop innovative product candidates, we are excited to expand our collaboration to include a second solid tumor target and to continue our work with Fate in developing first-in-class, off-the-shelf CAR-NK and CAR-T cell therapies for cancer patients.”

 “Our collaboration with ONO has focused on driving innovation in the field of cell therapy for solid tumors, and we are excited by the preclinical data we have observed with our first iPSC-derived CAR- T cell product candidate,” said Scott Wolchko, President and CEO of Fate Therapeutics. “We are impressed with the differentiated antigen binders that ONO has contributed to the partnership, and we are pleased to expand our collaboration to initiate preclinical development of collaboration products targeting a second solid tumor antigen.”

About Fate Therapeutics’ iPSC Product Platform

 The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.

 Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.