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Senti Biosciences Highlights RMAT Designation for SENTI-202 and AML Clinical Data
SNTI
Product Launch
New Projects/Investments
- Senti Biosciences participated in a Virtual Investor CEO Connect Segment on January 14, 2026, where CEO Timothy Lu discussed recent company news.
- The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202.
- SENTI-202 is a potential first-in-class investigational cell therapy for relapsed/refractory hematologic malignancies, including AML.
- This RMAT designation builds on the Orphan Drug Designation previously granted to SENTI-202 in June.
- New data from 20 patients (18 with evaluable responses) in the ongoing clinical trial of SENTI-202 for relapsed or refractory AML were presented at the American Society of Hematology (ASH) Annual Meeting.
Jan 14, 2026, 2:15 PM
SNTI Provides Update on Senti 202 Phase 1 Trial Results
SNTI
New Projects/Investments
- Senti 202, a first-in-class off-the-shelf logic-gated CAR-NK cell therapy for relapsed refractory Acute Myeloid Leukemia (AML), has shown promising updated results from its ongoing Phase 1 trial.
- In 20 relapsed refractory AML patients, the trial demonstrated a 50% overall response rate (ORR) and a 42% complete remission/complete remission with partial hematologic recovery (CR/CRh) rate at the recommended phase 2 dose.
- The therapy exhibited an excellent safety profile, with Senti 202-related adverse events predominantly being grade one or two pyrexia, supporting the potential for outpatient dosing.
- Senti 202 has received the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation.
- Senti plans to engage with the FDA in 2026 to discuss pivotal study plans, with the initiation of the pivotal study and expansion into additional indications also planned for later in 2026.
Dec 9, 2025, 1:00 PM
Senti Biosciences reports promising Senti 202 Phase 1 results
SNTI
New Projects/Investments
- Senti Biosciences (SNTI) reported updated Phase 1 trial results for Senti 202, a first-in-class off-the-shelf logic-gated CAR-NK cell therapy for relapsed refractory Acute Myeloid Leukemia (AML).
- In 20 heavily pretreated relapsed refractory AML patients, Senti 202 achieved a 50% overall response rate (ORR) and a 42% complete remission/complete remission with partial hematologic recovery (CR/CRh) rate at the recommended phase 2 dose.
- The therapy demonstrated durable responses, with an estimated median duration of composite CR of 7.6 months, and achieved 100% MRD negative rates in complete remission patients.
- Senti 202 has an excellent safety profile, with Senti 202-related adverse events being predominantly low-grade pyrexia, supporting potential for outpatient dosing.
- Senti 202 has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation, with plans to discuss pivotal study plans with the FDA and initiate a pivotal study in 2026.
Dec 9, 2025, 1:00 PM
Senti Biosciences Provides Senti 202 Clinical Trial Update
SNTI
New Projects/Investments
- Senti Biosciences reported promising updated results from its Phase 1 trial for Senti 202 in relapsed refractory AML, showing a 50% overall response rate (ORR) and a 42% complete remission (CR)/CRh rate at the recommended Phase 2 dose in 20 heavily pretreated patients.
- The responses were durable, with an estimated median duration of composite CR of 7.6 months, and 100% of complete remission patients were MRD negative.
- Senti 202 demonstrated an excellent safety profile, with the most frequent related adverse events being grade one or two pyrexia that resolved rapidly, supporting potential for outpatient dosing.
- The company received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation for Senti 202.
- Next steps include launching a pivotal study in relapsed refractory AML and exploring expansion into other indications such as newly diagnosed AML and pediatric AML, representing a multi-billion dollar commercial opportunity.
Dec 9, 2025, 1:00 PM
SNTI Announces Promising Phase 1 Trial Results for SENTI-202 in R/R AML
SNTI
New Projects/Investments
Product Launch
- Senti Bio's SENTI-202, a First-in-Class Off-the-Shelf Logic-Gated CAR NK Cell Therapy, demonstrated promising results in its ongoing Phase 1 trial for Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).
- In the trial involving 20 R/R AML patients, SENTI-202 achieved a 50% Overall Response Rate (ORR) and 42% CR/CRh rates at the Recommended Phase 2 Dose (RP2D), with an estimated median duration of composite CR of 7.6 months overall.
- The therapy showed an excellent safety profile, with Grade 1/2 pyrexia as the most common related adverse event, supporting potential outpatient dosing.
- SENTI-202 has received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation (ODD), and the company plans to launch a pivotal trial and expand into other indications, such as Newly Diagnosed AML, in 2026.
Dec 9, 2025, 1:00 PM
Senti Bio Announces Positive SENTI-202 Clinical Data and RMAT Designation
SNTI
Product Launch
New Projects/Investments
- Senti Biosciences announced updated Phase 1 clinical data for SENTI-202 in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) patients, demonstrating a 50% Overall Response Rate (ORR) and 42% Complete Remission/CRh at the Recommended Phase 2 Dose (RP2D).
- The data highlighted deep, MRD negative, durable complete remissions, with 100% of CRs and over 80% of all responses being MRD negative, and a median duration of composite Complete Remission of 7.6 months across all patients.
- SENTI-202 received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and previously received Orphan Drug Designation in June 2025, which supports its rapid advancement.
- The company plans to launch a pivotal trial and explore expansion into other indications for SENTI-202 in 2026.
Dec 9, 2025, 12:04 PM
Senti Bio Reports Q3 2025 Financial Results and Upcoming Clinical Data Readout
SNTI
Earnings
New Projects/Investments
- Senti Biosciences, Inc. reported a net loss of $18.1 million, or $0.69 per basic and diluted share, for the three months ended September 30, 2025.
- As of September 30, 2025, the company held cash and cash equivalents of approximately $12.2 million, compared to $48.3 million as of December 31, 2024.
- Research and development expenses increased to $10.5 million for the three months ended September 30, 2025, up from $8.7 million in the same period in 2024, primarily due to higher external services and supplies costs and personnel-related expenses.
- Senti Bio announced it will present updated clinical data for its Phase 1 SENTI-202 study in Acute Myeloid Leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting in December 2025.
Nov 13, 2025, 9:38 PM
Sentebio Provides Update on Logic Gate Technology and SENTY-two zero two Program
SNTI
New Projects/Investments
Product Launch
Guidance Update
- Sentebio is advancing its logic gate technology designed to selectively target cancer cells while sparing healthy cells, with applications in both NK and T cells for liquid and solid tumors.
- The company's lead program, SENTY-two zero two, an off-the-shelf allogeneic CAR NK cell, is currently in a Phase 1 dose expansion clinical study for relapsed/refractory Acute Myeloid Leukemia (AML).
- SENTY-two zero two is engineered to target CD33 or FLT3 on AML cells while utilizing a "not gate" to protect healthy bone marrow stem cells by recognizing EMCN.
- Preliminary efficacy data from April showed that 5 out of 7 evaluable patients achieved an overall response rate (ORR), with 4 out of 7 achieving a composite complete response (CR) and MRD negative response.
- Sentebio anticipates reporting additional Phase 1 data before the end of this year, which will include data from approximately 20 patients and longer durability follow-up.
Oct 21, 2025, 3:35 PM
Senti Biosciences Provides Update on Senti 202 Phase 1 Trial for AML
SNTI
New Projects/Investments
Guidance Update
- Senti Biosciences' lead program, Senti 202, is an off-the-shelf allogeneic CAR NK cell therapy utilizing logic gate technology, currently in a Phase 1 dose expansion study for relapsed/refractory Acute Myeloid Leukemia (AML).
- The therapy is designed to target CD33 or FLT3 on cancer cells while protecting healthy cells by recognizing EMCN via a NOT gate.
- Preliminary Phase 1 data reported in April indicated Senti 202 was well tolerated with no SAEs or DLTs attributable to the product.
- 5 out of 7 evaluable patients achieved an overall response rate (ORR), with 4 out of 7 achieving a composite CR, and all responders achieving MRD negative status.
- Senti Biosciences anticipates reporting additional Phase 1 data by the end of 2025 and plans to advance the program into a pivotal study, with potential for outpatient administration.
Oct 21, 2025, 3:35 PM
Senti Biosciences Presents Positive Preliminary Phase 1 Data for SENTI-202 in AML
SNTI
New Projects/Investments
- Senti Biosciences is a logic-gated cell therapy company developing treatments for acute myeloid leukemia (AML) and other blood cancers, with their lead program being SENTI-202.
- SENTI-202 is a first-in-class, off-the-shelf NK cell therapy for AML, which recently received orphan drug designation.
- The therapy is engineered with an OR logic gate to target CD33 and FLT3 on cancer cells (including leukemic stem cells) and a NOT logic gate (endomucin) to protect healthy hematopoietic stem cells.
- Preliminary efficacy data from the ongoing Phase 1 clinical trial showed positive results, with two out of three patients in the recommended Phase 2 dose (RP2D) cohort achieving complete remission (CR) and being MRD negative.
- The trial demonstrated a favorable safety profile for SENTI-202, with no grade 3 or serious adverse events directly related to the therapy.
Sep 24, 2025, 4:55 PM
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