1. SENTI-202 shows 50% overall response rate in R/R AML patients. 2. 42% achieve complete remission, with most responses being MRD negative. 3. FDA grants SENTI-202 RMAT designation, indicating potential accelerated development. 4. SENTI-202 exhibits a favorable safety profile with no serious adverse events. 5. Further studies may expand therapies to newly diagnosed AML and MDS.
FAQ
Why Very Bullish?
The strong efficacy data and FDA RMAT designation position SNTI for significant market interest. Historical data indicates similar approvals positively impacted biotech stocks significantly.
How important is it?
The breakthrough data could attract investors, enhance the company's valuation, and expand market adoption significantly.
Why Long Term?
As pivotal studies progress, increased investor confidence and potential product launch could drive sustained growth, similar to other biotech advancements.
Senti Bio Reports Promising Clinical Data for SENTI-202 in R/R AML Patients
On December 9, 2025, Senti Biosciences, Inc. (Nasdaq: SNTI) unveiled compelling findings from its ongoing Phase 1 trial of SENTI-202, a groundbreaking therapy aimed at treating relapsed or refractory Acute Myeloid Leukemia (R/R AML). During an oral presentation at the American Society of Hematology (ASH) Annual Meeting in Orlando, the company highlighted significant efficacy results, including a 50% overall response rate (ORR) and a favorable safety profile.
Key Highlights of SENTI-202 Data
- 50% ORR noted in a cohort of 12 patients receiving the Recommended Phase 2 Dose (RP2D).
- 42% of patients achieved Complete Remission (CR) or CR with Partial Hematologic Recovery (CRh).
- All complete remissions (CRs) and approximately 83% of responses were minimal residual disease (MRD) negative.
- The estimated median duration of composite Complete Remissions was 7.6 months.
Mechanism of Action and Safety Profile
SENTI-202 utilizes a unique OR/NOT Logic Gate mechanism, allowing for the targeted destruction of AML blasts and leukemic stem cells while preserving healthy hematopoietic stem and progenitor cells. The performance data further suggest:
- Significant AML blast reduction was observed, even in patients with high baseline levels.
- Responders demonstrated a greater than 10-fold decrease in AML leukemic stem cells.
Importantly, SENTI-202 exhibited a strong safety profile, with no dose-limiting toxicities reported, indicating its potential for outpatient administration.
Participant Background and Treatment History
The study population primarily consisted of heavily pretreated patients, with 65% presenting with adverse risk genetics. Most patients had undergone a median of two prior therapies, and all had received chemotherapy, including cytarabine and anthracyclines.
Expert Insights
Dr. Nosha Farhadfar, a hematologist at the Sarah Cannon Transplant & Cellular Therapy Program, commented on the robust performance and safety profile of SENTI-202, stating, “SENTI-202 continues to demonstrate deep, durable responses... I’m looking forward to continuing to participate in this clinical evaluation.”
Moreover, Timothy Lu, MD, PhD, CEO of Senti Biosciences, underscored the innovative approach of their Logic Gated cell therapies, emphasizing the potential multi-billion dollar market for SENTI-202 given its applicability to a wide range of AML patients.
Regulatory Milestones
Concurrently, Senti Bio announced that SENTI-202 has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, a recognition that highlights its potential to address significant unmet medical needs. Additionally, it received Orphan Drug Designation in June 2025, further supporting its clinical development.
Next Steps and Investor Engagement
To elaborate on these findings, Senti Biosciences will host a virtual conference call and webcast at 8:00 a.m. EST today. Investors and interested parties can tune in for a deeper dive into the clinical outcomes from the SENTI-202 trial.