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Senti Biosciences (NasdaqCM:SNTI) Update / Briefing Transcript
2025-12-09 14:02
Senti Biosciences Conference Call Summary Company Overview - **Company**: Senti Biosciences (NasdaqCM:SNTI) - **Focus**: Development of gene circuit-based therapies for cancer treatment, specifically targeting acute myeloid leukemia (AML) with Senti 202 Key Industry Insights - **Industry**: Oncology, specifically the treatment of relapsed refractory AML - **Current Treatment Landscape**: - Existing therapies yield low complete remission (CR) rates of 12%-25% and CR/CRh rates of 20%-35% [16][17] - Median overall survival for relapsed refractory AML patients is approximately five months [16] Core Points from the Call - **Senti 202 Overview**: - A first-in-class off-the-shelf logic-gated CAR-NK cell therapy targeting CD33 and FLT3 [8] - Achieved a 50% overall response rate and a 42% CR/CRh rate in a phase 1 trial with 20 heavily pretreated relapsed refractory AML patients [8][39] - 100% of complete remission patients were MRD negative, indicating significant clinical benefits [9][40] - **Mechanism of Action**: - Utilizes a logic-gated approach to selectively kill cancer cells while sparing healthy cells [6][7] - Incorporates an OR gate to recognize cancer targets and a NOT gate to protect healthy cells [6][11] - **Clinical Trial Results**: - Phase 1 trial demonstrated durable responses with a median duration of composite CR of 7.6 months [9][39] - High MRD negative rates correlate with better long-term outcomes [9][40] - Safety profile supports outpatient dosing, with most adverse events being low-grade and manageable [21][39] - **Regulatory Designations**: - Received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation, facilitating closer collaboration with the FDA [9][40] - **Market Potential**: - Addressable market for Senti 202 includes approximately 28,000 relapsed refractory AML patients in the U.S. and EU, with potential expansion into newly diagnosed AML and pediatric AML populations [13][14] Additional Important Insights - **Patient Population**: - The trial enrolled patients with multiple adverse risk characteristics, with a median age of 49 years and a history of multiple prior therapies [26][27] - Senti 202 is not restricted by mutation status, allowing it to benefit a broader range of patients [21] - **Future Directions**: - Plans to initiate pivotal studies in 2026, with ongoing discussions with the FDA regarding trial design [41][43] - Potential for expanding indications to include solid tumors and other hematological malignancies [45] - **Technology Platform**: - Senti's broader gene circuits platform includes various types of genetic circuits that enhance the efficacy and safety of cell and gene therapies [44][45] Conclusion - Senti 202 shows promising efficacy and safety in treating relapsed refractory AML, with a strong potential for market impact and future expansion into other indications. The innovative logic-gated approach may address significant unmet needs in oncology, particularly for patients with limited treatment options.
Senti Bio to Host Conference Call and Webcast to Discuss SENTI-202 Clinical Data Being Presented at the American Society of Hematology (ASH) Annual Meeting 2025 on Tuesday, December 9th at 8:00 AM ET
Globenewswire· 2025-12-04 13:45
Core Viewpoint - Senti Biosciences, Inc. is set to present updated clinical results for its SENTI-202 therapy at the ASH Annual Meeting on December 9, 2025, highlighting its innovative approach in treating hematologic malignancies [1][2]. Group 1: Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies for patients with incurable diseases, utilizing its proprietary Gene Circuit platform [4]. - The company aims to engineer Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [4]. Group 2: Product Details - SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy designed to target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [3]. - The therapy includes an OR GATE for activating CAR that targets CD33 and/or FLT3, a NOT GATE to protect healthy cells, and calibrated-release IL-15 to enhance cell persistence and activity [3]. - Currently, Senti Bio is enrolling adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies in a Phase 1 clinical trial for SENTI-202, which could be a first-in-class allogeneic treatment for AML/MDS patients [3]. Group 3: Conference Call Details - The conference call discussing the clinical results will be hosted by key executives including Timothy Lu, MD, PhD, and Kanya Rajangam, MD, PhD, along with a hematologist from the Sarah Cannon Research Institute [2]. - Interested participants can access the call via a domestic or international phone line, and the webcast will be available on the company's website for 90 days post-event [2].