Continued progress positions Company to report topline data for Phase 1 clinical trial of SENTI-202 before year-end SOUTH SAN FRANCISCO, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- 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 it has confirmed the recommended Phase 2 dose (RP2D) in its Phase 1 study of SENTI-202, the Company's potential first-in-class L ...

Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [2][3] - The company's lead program, SENTI-202, is a first-in-class CAR NK cell therapy targeting hematologic malignancies, currently in a Phase 1 clinical trial with positive preliminary data [3] - SENTI-202 has received Orphan Drug Designation from the FDA for treating relapsed/refractory hematologic malignancies, including AML [3] Company Overview - Senti Bio aims to create new medicines for patients with incurable diseases by engineering Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells [5] - The company's pipeline includes cell therapies designed to address challenging liquid and solid tumor indications, with Gene Circuits shown to work in both NK and T cells [5] - Senti Bio is also exploring the application of Gene Circuits in other diseases beyond oncology through partnerships [5]

Core Insights - Senti Biosciences, Inc. announced progress in the Phase 1 clinical trial of SENTI-202 for treating Acute Myeloid Leukemia (AML), with the FDA granting Orphan Drug Designation for the therapy [1][2] - The company aims to address the significant unmet need in relapsed/refractory AML, which has a median survival rate of only 5.3 months [2] - SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy cells [2] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company’s pipeline includes cell therapies engineered with Gene Circuits targeting challenging liquid and solid tumor indications [4] - Senti Bio's Gene Circuits have shown preclinical efficacy in both NK and T cells, with potential applications beyond oncology [4] Regulatory Milestone - The FDA's Orphan Drug Designation provides Senti Bio with various benefits, including tax credits and exemptions from certain FDA fees, as well as potential market exclusivity for seven years post-approval [3]

Core Insights - Senti Biosciences, Inc. has received an additional $1.0 million from the California Institute of Regenerative Medicine (CIRM) for achieving clinical study enrollment milestones, bringing the total received from an $8 million grant to $7.4 million [1] - The company is developing SENTI-202, a first-in-class Logic Gated off-the-shelf CAR-NK cell therapy aimed at treating relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML) [1][3] - Preliminary results from the ongoing Phase 1 trial of SENTI-202 indicate it is well-tolerated, with no dose-limiting toxicities reported and a recommended Phase 2 dose identified as 1.5 x 10^9 CAR NK cells [4] Company Overview - Senti Bio is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, which aims to enhance precision and control in targeting cancer cells while sparing healthy cells [5] - The company's pipeline includes cell therapies engineered with Gene Circuits to address challenging liquid and solid tumor indications, demonstrating preclinical efficacy in both NK and T cells [5] Clinical Development - SENTI-202 is currently in a Phase 1 clinical trial (NCT06325748) and has shown promising preliminary results, with two out of three patients in the recommended Phase 2 dose cohort achieving a composite Complete Remission (cCR) [4] - The trial data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 supports the Logic Gate mechanism of action, with four out of four cCR patients being Measurable Residual Disease Negative (MRD-) [4]

Core Insights - Senti Biosciences, Inc. is advancing its lead asset, SENTI-202, a first-in-class off-the-shelf CAR NK cell therapy targeting hematologic malignancies like AML and MDS [2][3] - The company has reported positive preliminary results from a Phase 1 clinical trial, indicating SENTI-202 is well-tolerated with no dose-limiting toxicities [4] - The mechanism of action for SENTI-202 involves a novel gene circuit that selectively kills leukemia cells while sparing healthy hematopoietic stem cells [3][8] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [2][6] - The company's pipeline includes engineered cell therapies targeting both liquid and solid tumors, leveraging synthetic biology for enhanced precision and control [6] Clinical Trial Details - SENTI-202 is currently in a Phase 1 trial enrolling adult patients with relapsed/refractory CD33 and/or FLT3-expressing hematologic malignancies [3] - The preliminary recommended Phase 2 dose (RP2D) for SENTI-202 was identified as 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles following lymphodepleting chemotherapy [4] - In the preliminary RP2D cohort, 2 of 3 patients achieved a composite Complete Remission (cCR), and 5 of 7 evaluable patients achieved an overall response rate (ORR) [4] Mechanism of Action - SENTI-202 utilizes a Logic Gated gene circuit to activate CAR targeting CD33 and/or FLT3, which are expressed in approximately 95% of AML patients [8] - The therapy protects healthy hematopoietic stem and progenitor cells (HSC/HSPCs) from off-tumor effects through an inhibitory CAR targeting Endomucin (EMCN) [8]

Core Insights - Senti Biosciences, Inc. presented positive Phase 1 data for its lead program SENTI-202 at the AACR Annual Meeting, indicating potential as a treatment for Acute Myeloid Leukemia (AML) with 4 out of 7 patients achieving composite Complete Remission (cCR) [1][3][4] - The company reported financial results for Q1 2025, showing a net loss of $14.1 million, with cash and cash equivalents of approximately $33.8 million as of March 31, 2025 [9][14] Clinical Data Highlights - SENTI-202 was well tolerated with no dose-limiting toxicities, and the preliminary recommended Phase 2 dose (RP2D) was identified as 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles [4] - All 4 patients who achieved cCR were measurable residual disease (MRD) negative, and responses have been maintained for follow-ups ranging from 4+ to 8+ months [1][4] - The ongoing enrollment in the Phase 1 study aims to confirm the RP2D and expand into disease-specific cohorts [1][3] Corporate Developments - The company is advancing its Logic-Gated cell therapy approach, which may have applications in both liquid and solid tumors, providing multiple pipeline expansion opportunities [1][2] - Senti Bio has joined the Webull Corporate Connect Service platform to enhance communication with shareholders and increase market visibility [5] Financial Overview - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024, primarily due to higher external services costs [9][14] - General and administrative expenses decreased to $7.1 million in Q1 2025 from $7.5 million in Q1 2024 [9][14] - The total operating expenses for the quarter were $16.4 million, slightly up from $16.3 million in the same period last year [9][14]

Core Insights - Senti Biosciences, Inc. presented positive preliminary data from the Phase 1 clinical trial of its investigational cell therapy SENTI-202 for treating relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML) [3][5] - SENTI-202 is designed as a first-in-class off-the-shelf therapy that selectively targets CD33 and/or FLT3 antigens while sparing healthy cells, potentially widening the therapeutic window [5][6] - The company is currently enrolling adult patients with R/R CD33 and/or FLT3-expressing hematologic malignancies in the ongoing Phase 1 clinical trial [5] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [2][8] - The company's pipeline includes engineered cell therapies targeting challenging liquid and solid tumor indications, leveraging synthetic biology for enhanced precision and control [8] Industry Context - Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults, with an estimated 20,800 new cases in the U.S. in 2024 and a five-year survival rate of approximately 30% [7] - Current treatment options for R/R AML are limited, with median overall survival typically around five months [7]