Noticias y eventos de Senti Biosciences Holdings Inc (SNTI)SNTISenti Biosciences Holdings Inc

Senti Bio Signs Strategic Deal with Celadon, Potential Value of $60M for SENTI-202

Senti Bio announced a strategic transaction designed to sharpen its focus on next-generation controllable genetic medicines powered by its Regulator Dial technology platform and unlock value for its Gene-Circuit-enabled pipeline, including SENTI-202, currently being advanced by its wholly owned subsidiary, Senti Biosciences. Under the terms of this transaction, a newly formed privately held biotechnology company controlled by affiliates of Celadon, the company's largest investor, will acquire the company's assets relating to its Gene-Circuit-enabled pipeline, including the rights to SENTI-202 in exchange for a contingent value right, or CVR, which will be distributed to equity holders providing up to $60M in milestone payments over a seven-year period tied to the future success of SENTI-202. After the closing of the transaction, SBH plans to seek additional financing to allow its team to focus on advancing early-stage programs built around its proprietary Regulator Dial platform, including a controllable gene therapy for Rett Syndrome and controllable, armored tumor-infiltrating lymphocytes for solid tumors designed to improve efficacy and safety. NewCo intends to continue development of SENTI-202. The CVR milestone structure consists of: $10M upon filing and acceptance of a biologics license application, or BLA, for SENTI-202; $20M upon FDA approval of a BLA for SENTI-202 and $30M upon achievement of $200M in cumulative net sales of SENTI-202. The CVR structure is intended to give SBH's stockholders value in connection with future development, regulatory, and commercial achievements while enabling the NewCo to focus resources on advancing SENTI-202 and the Gene Circuits franchise. The transaction has been approved by SBH's board of directors and remains subject to customary closing conditions, including approval by SBH's stockholders and other conditions set forth in the definitive agreement.

Senti Bio Completes FDA RMAT Meeting, Advances SENTI-202 Clinical Trial

Senti Bio announced the successful completion of a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy, or RMAT, meeting with the FDA regarding SENTI-202, the company's Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia and updated Phase 1 clinical data. Following the RMAT meeting, the company has finalized its pivotal clinical and chemistry, manufacturing and controls strategy for SENTI-202. The company plans to implement a single-arm, multi-center pivotal trial intended to support potential SENTI-202 registration in patients with R/R AML. This study is expected to evaluate SENTI-202 administered following lymphodepletion chemotherapy in a patient population consistent with the Phase 1 trial population. In addition to the RMAT meeting, after conducting exploratory efficacy covariate analysis of the Phase 1 trial results, Senti has identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1 versus 12.5% achieving a cCR when they received SENTI-202 manufactured from non-Donor X NK cells. As a result of this discovery, all future SENTI-202 manufacturing, including for pivotal study use, will use Donor X material. The Donor X attribute is found in ~50% of adult donors, and published literature supports increased NK cell cytotoxicity in donors with this phenotype. The Donor X NK phenotype is independent of HLA or KIR matching, thus supporting SENTI-202's allogeneic off-the-shelf usage. Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X product. Senti Bio also announced that SENTI-202 continues to exhibit durable MRD-negative responses in the full 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for R/R AML. At RP2D, across all patients receiving a mix of Donor X and non-Donor X material, an ORR of 44% and cCR of 37.5% was observed with 100% of CRs being MRD negative. The complete remissions continue to be durable, with all the CR/CRh responders who were in remission as of the data-cut supporting the oral presentation at the 2025 ASH annual meeting continuing to maintain remission with an additional 7 months of follow up, the longest duration being 21+ months.

Senti Bio CEO Reveals Strategic Progress for 2026

"We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development," said Timothy Lu, Chief Executive Officer and Co-Founder of Senti Bio. "Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 - a Regenerative Medicine Advanced Therapy designated product - regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn."