Fate and Ono Initiate Enrollment for HER2-CAR T Trial


FT825 is an iPSC-derived multiplexed-engineered, CAR T-cell therapy targeting HER2 with a novel antigen binding domain.

Scott Wolchko

Scott Wolchko

Fate Therapeutics has initiated enrollment for its phase 1 clinical trial (NCT03155061) evaluating FT825 (ONO-8250) in patients with HER2-expressing advanced solid tumors.1

“Since the formation of our partnership with Ono in 2018, we have worked closely together to pioneer the manufacture of CD8 alpha-beta T cells from iPSCs and to discover and integrate novel synthetic controls of cell function into our iPSC-derived CAR T-cell product platform for safe and effective treatment of solid tumors, including functional elements designed to promote cell trafficking, resist immune suppression in the tumor microenvironment, and preferentially target cancer cells,” Scott Wolchko, President and Chief Executive Officer, Fate Therapeutics, said in a statement.1 “The preclinical data for FT825 / ONO-8250 indicate a highly-differentiated therapeutic profile across a broad range of solid tumors, with the novel HER2-targeted antigen binding domain demonstrating selective targeting of cancer cells expressing HER2 including those with low expression. We are excited to initiate the Phase 1 study in collaboration with Ono and assess the potential to benefit patients with hard-to-treat advanced solid tumors who currently have limited treatment options.”

The phase 1 trial is designed to investigate a single dose of FT825 monotherapy and in combination with monoclonal antibody therapy in previously-treated patients with advanced solid tumors. The trial will primarily evaluate safety, tolerability, and pharmacokinetics, as well as overall response rate, duration of response and disease control rate, and will have a dose escalation and dose expansion portion.

FT825 is an iPSC-derived multiplexed-engineered, chimeric antigen receptor (CAR) T-cell therapy targeting human epidermal growth factor receptor 2 (HER2) with a novel antigen binding domain designed to overcome unique challenges in treating solid tumors. The therapy is designed using Fate’s iPSC Product Platform and incorporates 7 novel synthetic controls of cell function including a CXCR2 receptor, a chimeric TGFβ receptor, and a high-affinity, non-cleavable CD16a receptor, to promote cell trafficking, redirect immunosuppressive signals in the tumor microenvironment, and enable antibody-dependent cellular cytotoxicity.

WATCH NOW: Benjamin L. Schlechter, MD, on TAC01-HER2 in HER2-Positive Solid Tumors

FT825 previously demonstrated potency and specificity for HER2-expressing cancer cells in preclinical data presented at the 2023 Society for Immunotherapy of Cancer Annual Meeting.In accordance with a Collaboration and Option Agreement, Fate will jointly develop and commercialize the therapy with Ono in the United States and Europe, and Ono maintains exclusive development and commercialization rights in the rest of the world.

“We achieved several key milestones for our iPSC product platform in oncology and autoimmunity, creating additional opportunities to generate new clinical data across multiple programs during 2024,” Wolchko said in a recent company update.2 “We have initiated patient enrollment in our Phase 1 study of FT522, our ADR-armed, CD19-targeted CAR NK cell program, where we intend to assess FT522 with and without conditioning chemotherapy in patients with B-cell lymphoma. In addition, our IND application was cleared by the FDA for FT825/ONO-8250 in solid tumors under our collaboration with ONO Pharmaceutical, which multiplexed-engineered CAR T-cell program incorporates seven synthetic controls of cell function including a novel cancer-specific binding domain targeting HER2. Finally, I am pleased to announce the expansion of our iPSC product platform into autoimmunity with the clearance by the FDA of our IND application for FT819, our off-the-shelf, CD19-targeted CAR T-cell program, in systemic lupus erythematosus.”

1. Fate Therapeutics Announces Initiation of Phase 1 Clinical Trial for FT825 / ONO-8250 in Patients with HER2-expressing Advanced Solid Tumors. News release. Fate Therapeutics. January 8, 2024. https://finance.yahoo.com/news/fate-therapeutics-announces-initiation-phase-130000499.html
2. Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates. News release. Fate Therapeutics. November 8, 2023. https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-reports-third-quarter-2023-financial-results
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