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Fate Therapeutics to Showcase Innovative Off-the-Shelf CAR T-Cell Platform at ASGCT Annual Meeting

• Fate Therapeutics will present five studies on its iPSC-derived CAR T-cell therapy platform at the upcoming ASGCT Annual Meeting, highlighting potential applications across autoimmune diseases and cancer.

• The company's lead candidate FT522, featuring novel Alloimmune Defense Receptor technology, will be featured in an oral presentation showing how it may eliminate the need for conditioning chemotherapy in patients.

• Preclinical data will demonstrate Fate's progress in developing off-the-shelf cell therapies targeting solid tumors, including FT836, a novel MICA/B-targeting CAR T-cell therapy with broad activity across multiple cancer types.

Fate Therapeutics, Inc. (NASDAQ: FATE) announced today that it will present five studies featuring its induced pluripotent stem cell (iPSC)-derived cellular immunotherapies at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting in New Orleans, Louisiana on May 13-17, 2025.
The clinical-stage biopharmaceutical company will deliver an oral presentation on translational data from its Phase 1 clinical trial of FT522, an off-the-shelf, CD19-targeted CAR NK cell product candidate for patients with relapsed/refractory B-cell lymphoma. FT522 incorporates the company's proprietary Alloimmune Defense Receptor (ADR) technology, designed to reduce or eliminate the need for conditioning chemotherapy in patients receiving cell therapies.
In addition to the FT522 presentation, Fate will showcase preclinical data from its off-the-shelf, iPSC-derived CAR T-cell product platform across multiple therapeutic areas, including autoimmune diseases, hematological malignancies, and solid tumors.

Pioneering Conditioning-Free Cell Therapy

A significant challenge in current CAR T-cell therapies is the requirement for lymphodepleting conditioning chemotherapy, which can cause severe side effects and complications for patients. Fate's ADR technology aims to address this limitation by enabling cell therapies to function effectively without prior conditioning regimens.
"Our ADR technology represents a potential paradigm shift in how cell therapies can be administered," said a spokesperson from Fate Therapeutics. "By eliminating the need for conditioning chemotherapy, we hope to make these treatments more accessible and less toxic for patients with cancer and autoimmune diseases."
The company's oral presentation will detail how FT522, the first product candidate incorporating ADR technology, performs in patients with relapsed/refractory B-cell lymphoma in the ongoing Phase 1 clinical trial (NCT05950334).

Expanding Applications Across Multiple Diseases

Fate's poster presentations will highlight the versatility of its iPSC-derived cell therapy platform across various indications:
One poster will demonstrate how combining ADR technology with genetic ablation of adhesion ligand CD58 promotes functional persistence of allogeneic cell therapies without conditioning chemotherapy.
Another presentation focuses on targeting uPAR with multiplexed-engineered iPSC-derived CAR T cells to potentially reverse age- and insult-related fibrotic diseases, expanding the platform's potential beyond cancer.
The company will also present data on next-generation off-the-shelf CAR T-cell therapies for conditioning-free treatment of autoimmune diseases and hematologic malignancies.

Advancing Solid Tumor Treatment

Particularly noteworthy is Fate's presentation on FT836, a novel MICA/B-targeting CAR T-cell therapy engineered to eliminate the need for conditioning chemotherapy while demonstrating broad activity across solid tumor indications.
Solid tumors have historically been challenging targets for cell therapies due to their immunosuppressive microenvironment and heterogeneity. FT836 represents Fate's approach to overcoming these obstacles through innovative engineering of iPSC-derived CAR T cells.

iPSC Platform Advantages

Fate's proprietary iPSC product platform combines multiplexed engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. This approach allows for the mass production of well-defined, uniform cell products that can be stored for off-the-shelf availability.
Human iPSCs possess unique properties of unlimited self-renewal and differentiation potential into all cell types of the body. By utilizing clonal master iPSC lines as starting material, Fate can manufacture engineered cell products that overcome limitations associated with patient- and donor-sourced cell therapies.
The company's intellectual property portfolio supporting this platform includes over 500 issued patents and 500 pending patent applications.

Meeting Presentation Details

The oral presentation on FT522 will take place on Saturday, May 17, 2025, at 11:00 AM CT in Room 391-392 during the "Innovation in Alternative Cell Therapy Sources" session.
Poster presentations will be held on:
  • Tuesday, May 13, 2025, at 6:00 PM CT (Posters #758 and #789)
  • Wednesday, May 14, 2025, at 5:30 PM CT (Posters #1259 and #1229)
These presentations represent significant progress in Fate's mission to bring first-in-class iPSC-derived cellular immunotherapies to patients with cancer and autoimmune diseases.
As the field of cell therapy continues to evolve, Fate Therapeutics' innovative approach to developing off-the-shelf products could potentially address current limitations in manufacturing, accessibility, and patient safety, ultimately expanding treatment options for patients with difficult-to-treat conditions.
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