Fate Therapeutics, Inc. FATE announced that it has signed a global collaboration and option agreement with Janssen Biotech, a subsidiary of pharma giant J&J JNJ. Per the agreement, companies will develop novel chimeric antigen receptor (“CAR”) natural killer (“NK”) and CAR T-cell product candidates targeting four tumor-associated antigens for hematologic malignancies and solid tumors. Fate Therapeutics will use its iPSC product platform and Janssen’s proprietary tumor-targeting antigen binders to develop the candidates.
Per the terms of the deal, J&J will pay Fate Therapeutics $50 million in cash as upfront payment. In addition, J&J will make an additional $50 million equity investment in Fate Therapeutics’ stock at $31 per share. Fate Therapeutics is also eligible to receive up to $1.8 billion in development and regulatory milestones and up to $1.2 billion in commercial milestone payments from J&J. It will also receive royalties on sales from any approved product developed under the deal. Fate Therapeutics will advance candidates under the collaboration up to investigational new drug application (“IND”) filing and J&J has the option for an exclusive license for the development and commercialization of collaboration candidates. Moreover, J&J will also fund all manufacturing and development activities during clinical stage.
Shares of Fate Therapeutics rallied 23.4% during after-market trading on Apr 3. The deal will provide significant revenue streams, which the company can use to develop its own pipeline candidates. The company’s shares have increased 7.7% so far this year against the industry’s decline of 11.3% on the back of its encouraging progress with its pipeline.
Major players in the CAR-T cell-based product category include Bristol-Myers BMY and Celgene CELG. Bristol-Myers’ CAR-T candidate, lisocabtagene maraleucel, is under review in the United States for treating relapsed or refractory large B-cell lymphoma. J&J is also developing a CAR-T cell candidate for treating relapsed or refractory multiple myeloma in a phase Ib/II study.
The company is focused on developing programmed cellular immunotherapies for cancer and immune disorders. It has three early-stage candidates — FT500, FT516 and FT596 — in clinical development.
In December 2019, the company announced initial data on FT516 monotherapy study, which showed absence of morphologic evidence of leukemia (at day 42) along with complete neutrophil recovery in the first patient. In the same month, initial data from FT500 study showed no dose-limiting toxicities or FT500-related serious adverse events.
In January 2020, the FDA accepted second IND for FT516 to enable clinical study to evaluate the candidate in combination with PDL1-, PD1-, EGFR- and HER2-targeting monoclonal antibodies in several solid tumors. Fate Therapeutics announced dosing of the first patient in a phase I study evaluating another candidate, FT596, in patients with B-cell malignancies and chronic lymphocytic leukemia this month.
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