Fate Therapeutics Showcases Clinical Data for FT836 at the American Society of Cancer Oncology Annual Meeting
FT836 demonstrates meaningful reduction in target lesions without the use of conditioning chemotherapy in metastatic colorectal cancer
Detection of FT836 in the peripheral blood and tumor tissue illustrates the unique ability to traffic to tumor site and functionally persist without the reliance on conditioning chemotherapy in allogeneic patient setting
SAN DIEGO, June 01, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, presented clinical data this weekend featuring its off-the-shelf CAR T-cell program FT836 at the American Society of Cancer Oncology (ASCO) Annual Meeting being held in Chicago, IL, May 29 – June 2, 2026.
"Early Phase 1 data for FT836 represents a truly exciting moment for patients with certain advanced solid tumors who have exhausted their treatment options" said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "In this preliminary stage of the study, we are seeing notable tumor reduction in KRASwt metastatic colorectal cancer patients after treatment with FT836, an observation that did not require conditioning chemotherapy with the inclusion of our Sword and Shield™ technology. This novel 9-point edited CAR T-cell product candidate is uniformly manufactured from a single clonal master cell bank, meaning we can produce FT836 at massive scale with consistency and have it available off-the-shelf and on-demand for broad access for cancer patients with unmet need. We believe FT836 has the potential to fundamentally change how solid tumor treatment is approached, especially in combination with standard-of-care therapies. We look forward to continuing to build on these early results as enrollment expands in the FT836 study."
Presentation Summary Includes:
Title: Preliminary Phase 1 Results of a MICA/B-targeted CAR T cell Designed to Overcome Solid Tumor Escape Mechanisms and Avoid the Requirement for Conditioning Chemotherapy
As of the April 20, 2026 data cutoff, nine patients have been enrolled across two regimens (Regimen C: FT836 + cetuximab, n=6 and Regimen E: FT836 + trastuzumab, n=3) with all patients evaluated for safety, and five available for initial efficacy assessment: (Regimen C, n=4 and Regimen E , n=1). Both regimens are administered without conditioning chemotherapy. Key findings include:
- Favorable safety profile with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft versus host disease (GvHD) observed across any patient or dose level for all nine patients.
- First-in-human evidence of FT836 trafficking to and persisting within tumor tissue without the use of conditioning chemotherapy, along with evidence of remodeling of the tumor immune microenvironment.
- Preliminary anti-tumor activity in the two efficacy-evaluable heavily pre-treated KRAS wild-type (KRASwt) metastatic colorectal cancer (mCRC) patients, each with seven prior lines of therapy, including meaningful reductions in target lesion size and significant decreases in tumor biomarker expression, including carcinoembryonic antigen (CEA) expression. Based on these promising results, the Company plans to focus on this CRC patient population.
Sword and Shield™ Technology Facilitates CAR T-cell Activity without the Need for Conditioning Chemotherapy
FT836 incorporates Sword and Shield™ technology—a coordinated dual-engineering strategy designed to eliminate the need for lymphodepleting conditioning chemotherapy. The Sword component, an alloimmune-defense receptor (ADR), enables FT836 to selectively recognize and eliminate alloreactive host immune cells, including T cells, that would otherwise reject the allogeneic product. The Shield component, deletion of CD58, renders FT836 resistant to host immune cell surveillance, further supporting functional persistence of FT836. In previously presented preclinical data, these elements together enabled ~20–30x improvement in in vivo persistence in various allogeneic mouse models and ~5x selective containment of product-specific host immune responses, supporting the planning of clinical strategies without conditioning chemotherapy—a critical differentiator for patient tolerability and access.
FT836 Persistence in the Periphery and Tumor Tissue
A critical translational finding from this study is the first-in-human detection of FT836 in both peripheral blood and tumor tissue without conditioning chemotherapy. Using multi-parameter flow cytometry, FT836 cells were detected in the peripheral blood of patients with an intact host immune system following first dose, peaking at Day 4 and persisting for approximately another week. Strikingly, FT836 was subsequently detected in patient tumor biopsy at Day 22 by transgene-targeted RNAscope, which is well beyond their detection in the periphery, suggestive of efficient trafficking to tumor-bearing tissue and markedly prolonged tissue persistence relative to blood. This extended tissue residence, supported by CXCR2 trafficking receptor and TGFβ signal redirect receptor engineered into FT836, was accompanied by meaningful remodeling of the tumor immune microenvironment. Immunohistochemistry imaging from liver biopsy revealed that CD8+ T cells, which were spatially excluded from the tumor at baseline, were found adjacent to and in direct contact with tumor cells on-study; evidence of treatment-associated activation and recruitment of endogenous anti-tumor immunity.
Clinical Case Studies: Broad expression of MICA/B antigen and Anti-Tumor Activity in KRASwt Metastatic Colorectal Cancer
Screening biopsies from both patients confirmed broad expression of MICA/B and EGFR target antigens on tumor cells, validating the multi-antigen targeting rationale of FT836 plus cetuximab in mCRC.
Case 1: Regimen C DL1 — 19% Tumor Reduction; All target lesions reduced; 62% CEA Decline
A 45-year-old male with KRASwt metastatic CRC and lung, bone, and nodal disease received FT836 at 300 million cells/dose on Days 1 and 15 with cetuximab (no conditioning chemotherapy), following seven prior lines of therapy including prior cetuximab.
- CEA tumor marker decreased from 487 ng/mL at screening to 185 ng/mL by Day 56 (62% reduction).
- All RECIST target lesions decreased in size; overall 19% reduction in sum of diameters (70 mm → 55 mm) across lung and nodal lesions.
- No FT836-related adverse events observed.
Case 2: Regimen C DL2 — 52% Liver Lesion Reduction; Stable Disease; Pain associated with tumor Resolved
A 53-year-old male with KRASwt metastatic CRC involving lung, liver, adrenal, and nodal disease received FT836 at 900 million cells/dose on Days 1, 8, and 15 with cetuximab (no conditioning chemotherapy), following seven prior lines of therapy including multiple cetuximab-containing regimens.
- A liver target lesion demonstrated a 52% reduction in diameter; RECIST-assessed stable disease confirmed post data cutoff.
- Cancer antigen (CA)19-9 decreased from 258 to 144 by Day 56 (44% reduction).
- Tumor-related pain resolved during treatment.
- No FT836-related adverse events observed.
About FT836
FT836 is the Company's multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company's first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company's novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company's progress, plans and timelines for the clinical investigation of its product candidates, including the Company's plans to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company's clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company's product candidates, the availability of data from the Company's clinical trials and the Company's plans to provide updates on its clinical trials, the therapeutic and market potential of the Company's research and development programs and product candidates, the Company's clinical and product development strategy, and the Company's progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company's product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
