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Agreements

Date: 2018-09-17

Type of information: Development agreement

Compound: two off-the-shelf CAR-T cell product candidates

Company: Fate Therapeutics (USA - CA) Ono Pharmaceutical (Japan)

Therapeutic area: Cancer - Oncology

Type agreement:

  • development - commercialisation

Action mechanism: CAR-T cell therapy

Disease: lymphoblastic leukemias, solid tumors

Details:

  • • On September 17, 2018, Fate Therapeutics announced that it has entered into a collaboration with Ono Pharmaceutical for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates. Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. This transformative approach enables the cost-effective production of cell-based cancer immunotherapies that are uniformly engineered, extensively characterized and homogeneous in composition, and can be consistently and repeatedly mass produced and delivered to patients in an off-the-shelf manner.
  • Under the terms of the strategic option agreement, Fate Therapeutics and Ono will jointly advance each iPSC-derived CAR-T cell collaboration candidate to a pre-defined preclinical milestone. The first iPSC-derived CAR T-cell candidate targets an antigen expressed on certain lymphoblastic leukemias, and Fate Therapeutics retains global responsibility for development and commercialization with Ono having an option to assume responsibilities in Asia. The second candidate targets a novel antigen identified by Ono expressed on certain solid tumors, with Ono having an option to assume global responsibility for further development and commercialization and Fate Therapeutics retaining the right to co-develop and co-commercialize the candidate in the United States and Europe. For both collaboration candidates, Fate Therapeutics retains manufacturing responsibilities on a global basis.
   

Financial terms:

  • Fate Therapeutics will receive an upfront payment and committed research funding during the preclinical option period, and is eligible to receive a preclinical option exercise fee, clinical, regulatory and commercialization milestone payments and tiered royalties on net sales by Ono in connection with the development and commercialization of each collaboration product by Ono in the Ono territory.

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