SOUTH SAN FRANCISCO, Calif. — Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the Company’s potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, that is currently in development for the treatment of relapsed/refractory hematologic malignancies, including AML.
“This significant FDA designation validates both the tremendous need for better treatments for R/R AML and the promise of SENTI-202 to transform the therapeutic landscape for this notoriously aggressive cancer,” Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “We are incredibly pleased with the exciting clinical progress we recently shared at the ASH conference on SENTI-202.”
SENTI-202 is Senti Bio’s lead asset. The FDA granted the RMAT designation based on data from the Company’s ongoing Phase 1 clinical trial of SENTI-202 in adult patients with relapsed or refractory (R/R) CD33 and/or FLT3 expressing hematologic malignancies, including AML. Updated clinical data demonstrating SENTI-202’s efficacy, safety, and durability in treating R/R AML were presented orally on December 8 at the ASH Annual Meeting 2025. Pharmacodynamic data in ongoing clinical studies underscore a clinical proof-of-mechanism for ‘OR/NOT’ Logic Gate, showing selective killing of leukemic blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells. RMAT marks SENTI-202’s second FDA recognition this year, following receipt of Orphan Drug Designation, which was granted in June 2025.
“Leveraging our Logic Gate technology, SENTI-202 has continued to demonstrate its ability to aggressively kill cancer cells while protecting normal cells for hard-to-treat cancers such as AML, a central challenge in oncology,” said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Senti Biosciences. “We view the FDA’s decision to grant RMAT and Orphan Drug designations to SENTI-202 as major milestones for the AML patient community and we look forward to working with regulators to develop this potentially first-in-class treatment as quickly as possible and to accelerate a paradigm shift in how we treat other difficult cancers.”
At the ASH Annual Meeting, Senti delivered two presentations, including one oral and one poster, on its SENTI-202 clinical program. The Company presented updated clinical data from the patients included in the published abstracts, as well as additional patients’ clinical data from a more recent data-cut. The Company’s ASH oral and poster presentations can be found on its website through the following links: Oral Presentation, Poster. Senti will also host a webcast on Tuesday, December 9, 2025 at 8:00 a.m. EST to discuss the results.
The FDA established the RMAT designation to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases where early clinical evidence indicates the potential to address an unmet medical need. The designation provides benefits similar to the FDA’s Breakthrough Therapy and the Fast Track programs, including enhanced and frequent interactions with the Agency throughout development, and eligibility for expedited review mechanisms such as rolling and priority review.
For more information about the ongoing Phase 1 trial, visit clinicaltrials.gov and reference identifier NCT06325748.
About SENTI-202
SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy product designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE, which is an activating CAR that recognizes and kills CD33 and/or FLT3 expressing cells. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts (that largely express CD33) and leukemic stem cells (that predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE, which is an inhibitory CAR that is designed to recognize EMCN selectively expressed on healthy hematopoietic stem and progenitor cells and protect those healthy cells from being killed even if they express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15, which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, and cryopreserved to be available off-the-shelf for use as needed. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic treatment for AML/MDS patients.
Earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.
About Senti Bio
Senti Bio is a clinical-stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging its synthetic biology platform to engineer Gene Circuits into new medicines with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. The Company’s wholly-owned pipeline comprises cell therapies engineered with Gene Circuits to target challenging liquid and solid tumor indications. Preclinical work supports the Senti Gene Circuits’ ability to work in both NK and T cells. Senti Bio has also preclinically demonstrated the potential breadth of Gene Circuits in other modalities and diseases outside of oncology and continues to advance these capabilities through partnerships.
For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (SentiBio) and LinkedIn (Senti Biosciences)
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