ONO exercises Fate CAR-T option in latest twist to partners’ four-year deal

While some of the biggest players have jumped on CAR-T therapies and their potential in medicine, one of the newest developments in the space involves two smaller players.

Immunotherapy and oncology player Fate Therapeutics put out word Monday that collaborator ONO Pharmaceutical is exercising its option for HER2-targeting CAR-T cell therapy called FT825/ONO-8250. The option for the preclinical candidate, according to the biotechs, is that the pair will jointly develop and commercialize the drug for the US and Europe, and ONO will maintain exclusive development and commercialization rights for the rest of the world.

In exchange, Fate remains eligible for milestone payments and tiered royalties on ex-US and ex-Europe sales — but those numbers remain undisclosed.

Toichi Takino

ONO executive Toichi Takino, out of its R&D division, said in a statement that the biotech is looking forward to initiating clinical development for the therapy. Fate’s CEO Scott Wolchko added that the goal is to submit an IND to the FDA by next year.

Fate did not respond to a request for comment from Endpoints News.

The collaboration between the two has been going on for more than four years, when Fate announced the collaboration with ONO in September 2018 to jointly develop and commercialize two off-the-shelf CAR-T candidates. In the original announcement, Fate and ONO teamed to jointly advance both candidates to a pre-determined clinical milestone. The first candidate was to target an antigen in certain types of leukemia, with Fate retaining global responsibility and giving ONO the option to take responsibility in Asia.

The second candidate from that collaboration is more familiar — targeting an antigen on solid tumors, giving ONO the option to take global responsibility and having Fate retain the rights for co-development and co-commercialization in both the US and Europe.

On top of all of that, Fate retains manufacturing responsibilities.

It is also worth noting that the two companies recently widened the scope of their collaboration to “initiate preclinical development of an additional program targeting a second solid tumor antigen,” without disclosing what the target could be.

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