SENTI-202 / Senti Bio - LARVOL DELTA

Correlative data from an ongoing Phase 1, multicenter study of senti-202, a first-in-class, CD33 and/or FLT3 & not endomucin (EMCN), selective off-the-shelf CAR NK cell therapy for Acute Myeloid Leukemia (AML) is consistent with its clinical activity and unique logic gated mechanism of action (ASH 2025) - P1 | "Three dose cohortswere evaluated and the recommended phase 2 dose (RP2D) was determined as 1.5×109 CAR+ SENTI-202cells/dose given on Days 0, 7, and 14 of a 28-day cycle following lymphodepletion with fludarabine andcytarabine, based on the totality of clinical and correlative data.Patients on study had differing mutational status and proteomics, as expected with this heterogenousdisease...These LSCs were predominantly in G0 phase of the cell cycle atbaseline and therefore expected to be resistant to chemotherapeutic agents like cytarabine.In patient PB samples collected serially post SENTI-202 treatment, the repopulation of T cells, NK cells,neutrophils, and other immune cells was confirmed by flow cytometry in responders...The presence of EMCN+ HSPCs in responder BM, as well as repopulationof BM and PB hematopoietic subpopulations, is consistent with the pharmacodynamic action of theSENTI-202 Logic Gate in sparing EMCN+ HSPCs while selectively killing CD33+..."

Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • ADGRG1 • CD33 • CD34 • CD38 • EMCN • FLT3

Promising results from an ongoing Phase I multicenter study of senti-202, a first-in-class, CD33 and/or FLT3 & not endomucin (EMCN), selective off-the-shelf logic gated CAR NK cell therapy in adults with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) (ASH 2025) - P1 | "The study is designed to evaluate 2 Dose Levels (DLs) of SENTI-202 (1x109 & 1.5x109 CAR+ NKcells/dose) and 2 Dose Schedules (Sch) [Days 0, 7, 14 (Sch-I) or Days 0, 3, 7, 10, 14 (Sch-II)] followinglymphodepletion (LD) with fludarabine (30 mg/m2/day) and cytarabine (Ara-C) (2 g/m2/day) on Days -7 to -3...All pts received prior chemotherapy including Ara-C and 10 pts receivedprior venetoclax...Pharmacodynamic bone marrow cell population data were consistent with clinical responsesand SENTI-202's mechanism of action, i.e. reduction of blasts and LSCs along with preservation of HSPCsin cCR pts (additional details in separate Abstract ).Clinical data from the dose finding cohort of SENTI-202 in the ongoing Phase 1 trial reveals an excellentsafety profile for SENTI-202 administered after LD, and promising durable CRs (50% at RP2D, 42% overall,all MRD negative with median duration not reached and longest CR of 11+ mo). An expansion cohortenrolling R/R AML pts has..."

Clinical • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Malignancies • Leukemia • Neutropenia • CD33 • EMCN • FLT3

Senti Bio Announces Updated SENTI-202 Clinical Data from Ongoing Phase 1 Trial in Relapsed or Refractory Acute Myeloid Leukemia Patients… (GlobeNewswire) - "Data from 20 patients (18 with evaluable responses) were presented at the American Society of Hematology (ASH) Annual Meeting....50% (6/12) of patients at the Recommended Phase 2 Dose (RP2D) and 50% (9/18) of all trial patients achieved an Overall Response Rate (ORR) outcome. 42% (5/12) of patients at the RP2D and 39% (7/18) of all patients overall achieved a Complete Remission (CR) or CR with Partial Hematologic Recovery (CRh). 100% of all CRs and ~80%+ of all responses were MRD negative. With limited follow-up in the RP2D cohort, the Kaplan-Meier estimate of median duration of composite Complete Remissions across all patients is 7.6 months (6.1, NE)."

P1 data • Acute Myelogenous Leukemia

Senti Bio Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for SENTI-202 in the Treatment of Adults with Relapsed or Refractory Acute Myeloid Leukemia (GlobeNewswire) - "The FDA granted the RMAT designation based on data from the Company’s ongoing Phase 1 clinical trial of SENTI-202 in adult patients with relapsed or refractory (R/R) CD33 and/or FLT3 expressing hematologic malignancies, including AML."

FDA event • Acute Myelogenous Leukemia

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)

P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Sarah Cannon Research Institute to Present Research on Advances in Blood Cancers…at 2025 ASH Annual Meeting & Exposition (Sarah Cannon Research Institute (SCRI))

Clinical data • Acute Myelogenous Leukemia • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Waldenstrom Macroglobulinemia

Calibrated Release IL15 Bivalent CD33 and/or FLT3 and NOT Emcn Logic Gated Gene Circuit CAR-NK Cell Therapy (SENTI-202) in Venetoclax Resistant Patient Derived Xenograft Acute Myeloid Leukemia Models (ASH 2023) - "Our initial PDX studies used clinically relevant VEN/HMA-r AML PDX cells (designated as PDX1) obtained from a patient with FLT3-ITD, GATA2, and NRAS mutations, who initially responded to VEN/decitabine treatment but later relapsed. In conclusion, CAR-NK cells expressing the SENTI-202 OR Gate and crIL15 demonstrate robust anti-tumor activity against primary AML cells within in vitro cytotoxicity assays and in vivo AML PDX models, including VEN-r AML. These promising preclinical results highlight the potential of SENTI-202 as a targeted and selective therapy for AML, offering a new avenue for overcoming the challenges posed by the heterogeneity of the AML proteomic landscape."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33 • FLT3 • GATA2 • IFNG • IL15 • NRAS • PDX1 • TNFA

Senti Bio to Present Updated Clinical Results of First-in-Class Logic Gated CD33/FLT3 Cell Therapy, SENTI-202, at the American Society of Hematology (ASH) Annual Meeting 2025 (GlobeNewswire) - "Two presentations, including one oral session, build on existing data and show deep and durable clinical remission rates, combined with a strong safety profile, for SENTI-202 in treating relapsed/refractory Acute Myeloid Leukemia (AML). Pharmacodynamic data further underscore clinical proof-of-mechanism for 'OR/NOT' Logic Gate, showing selective killing of leukemic blasts and leukemic stem cells (LSCs) while sparing healthy hematopoietic stem and progenitor cells (HSPCs)....Senti Bio will present data from additional clinical trial participants and longer follow-up at the ASH presentations and in a live webcast during the ASH meeting in December."

P1 data • PK/PD data • Acute Myelogenous Leukemia

Senti Bio Participates in Virtual Investor “What This Means” Segment Discussing The Phase 2 Dose and Schedule Selection for SENTI-202 in its Clinical Trial for Acute Myeloid Leukemia (Yahoo Finance)

Clinical • Acute Myelogenous Leukemia

Senti Bio Reports Second Quarter 2025 Financial Results and Confirms Next Data Milestone for Phase 1 SENTI-202 Study in Acute Myeloid Leukemia (AML) Expected Q4 2025 (GlobeNewswire) - "'Our team has continued to advance SENTI-202’s clinical development. We have now completed dose finding and have confirmed the recommended Phase 2 dose (RP2D), which is an important step in our Phase 1 study. We are currently in the dose expansion phase, enrolling additional patients with relapsed/refractory AML at the RP2D.'....'expect to release additional efficacy and durability data from our ongoing Phase 1 study before the end of the year, representing a significant milestone for our lead program.'"

P1 data • Acute Myelogenous Leukemia

Senti Bio Determines Recommended Phase 2 Dose (RP2D) in Phase 1 Study of SENTI-202 for the Treatment of Relapsed/Refractory Hematologic Malignancies, Including Acute Myeloid Leukemia (GlobeNewswire) - "Senti Biosciences...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 Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, in development for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML). The Phase 1 clinical trial of SENTI-202 is enrolling adult patients with relapsed or refractory ('R/R') CD33 and/or FLT3 expressing hematologic malignancies....The RP2D has been determined as Schedule I, Dose Level 2 (i.e. 1.5 x 109 CAR+ NK cells/dose) administered on Days 0,7 and 14 of 28 Day Cycles following lymphodepleting chemotherapy and the trial is actively enrolling additional R/R AML patients into an expansion cohort at the RP2D. The Company expects to report clinical data, including efficacy and durability, from the expansion cohort before year-end."

P1 data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Senti Bio Granted U.S. FDA Orphan Drug Designation for Use of First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, SENTI-202 to Treat Acute Myeloid Leukemia (The Manila Times) - "Senti Biosciences, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML. Additionally, the Company released a Virtual Investor 'What This Means' segment to discuss the Orphan Drug Designation for SENTI-202."

Orphan drug • Acute Myelogenous Leukemia

Senti Bio Receives Additional $1.0 Million Tranche from California Institute for Regenerative Medicines (CIRM) Grant for Advancing Clinical Development of SENTI-202 (GlobeNewswire) - "Senti Biosciences, Inc...today reported the receipt of an additional $1.0 million from the California Institute of Regenerative Medicine (CIRM) upon the achievement of clinical study enrollment milestones. As previously announced, the CIRM awarded an $8 million grant to Senti Bio to support the ongoing clinical development of SENTI-202...for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML). To date, the Company has received a total of $7.4 million of the $8.0 million available under the grant."

Financing • Acute Myelogenous Leukemia

Senti Bio Releases Mechanism of Action Video for First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, SENTI-202 (GlobeNewswire) - "Video illustrates SENTI-202’s MoA, namely to selectively kill both AML blasts and leukemic stem cells (LSCs) while protecting healthy hematopoietic stem cells/ hematopoietic stem and progenitor cells (HSC/HSPCs) using its novel CD33 OR FLT3 NOT EMCN Logic-Gated gene circuit."

Clinical • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Senti Bio Reports First Quarter 2025 Financial Results and Provides a Corporate Update on Positive SENTI-202 Clinical Development (GlobeNewswire) - "we are continuing to advance our potential best-in-class Logic-Gated programs with additional discovery efforts for solid tumors, in order to continue building value in the near and long-term...Research and development expenses were $9.3 million and $8.8 million for the three months ended March 31, 2025 and 2024, respectively."

Commercial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

First-in-human, multicenter study of SENTI-202, a CD33/FLT3 selective off-the-shelf logic gated CAR NK cell therapy in hematologic malignancies including AML: Correlative data (AACR 2025) - P1 | "Interim flow cytometry & CyTOF analyses of patient PB & BM in SENTI-202-101 affirms the anti-leukemic effects of SENTI-202 in responding patients, as well as the repopulation of immune cell subpopulations post-treatment. The presence of EMCN+ HSPCs in responder BM, as well as repopulation of BM & PB hematopoietic subpopulations, is consistent with the pharmacodynamic action of the Logic Gate in SENTI-202 in sparing EMCN+ HSPCs while selectively killing CD33+ and/or FLT3+ AML tumor cells."

Clinical • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • ADGRG1 • CD33 • CD34 • CD38 • EMCN • FLT3

First-in-human, multicenter study of SENTI-202, a CD33/FLT3 selective off-the-shelf logic gated CAR NK cell therapy in hematologic malignancies including AML: Clinical data (AACR 2025) - P1 | "2 SENTI-202 Dose Levels (DLs): 1e9 & 1.5e9 CAR NK cells/dose & 2 Schedules: 3 or 5 doses/ 28-day Cycle (I on Days 0, 7, 14; & II on Days 0, 3, 7, 10, 14, respectively), following lymphodepletion (LD) with fludarabine and cytarabine are being evaluated. Preliminary PK profile is consistent with allogeneic NK cell therapies and CyTOF analyses reveal LSC killing & HSPC protection consistent with SENTI-202 Logic Gated Gene Circuit design. Dose finding is ongoing & additional data from pts in Schedule II will be reported."

Clinical data • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • CD33

SENTI-202 CD33 OR FLT3 NOT EMCN logic-gated gene circuit components selectively target AML while protecting human HSC/HPCs from off-tumor toxicity in a humanized mouse model (AACR 2025) - P1 | "The bivalent CD33 OR FLT3 activating CAR targets 2 AML antigens, CD33 & FLT3, enabling targeting of AML stem cells & blasts (Gonzalez, 2023; Kaveri, 2024) and venetoclax-resistant AML cells (Muftuoglu, 2023). In conclusion, the SENTI-202 CD33 OR FLT3 NOT EMCN logic-gated gene circuit enables exceptional efficacy against AML while protecting HSC/HPCs from off-tumor toxicity, demonstrating the potential of SENTI-202 as a targeted and precise therapy for AML. SENTI-202 is currently in Phase 1 clinical development in patients with relapsed/refractory hematologic malignancies including AML (NCT06325748)."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33 • EMCN • FLT3 • HER-2 • IL15 • PTPRC

Senti Bio’s SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML (GlobeNewswire) - P1 | N=21 | NCT06325748 | Sponsor: Senti Biosciences | "As presented at AACR, 9 patients with relapsed or refractory AML have been treated with various doses of SENTI-202 in the dose finding part of the study and 7 were evaluable for overall response at the data cut-off....2 of 3 patients in the preliminary RP2D cohort achieved a composite Complete Remission (cCR); 5 of the 7 best overall response evaluable patients achieved an ORR (cCR + morphologic leukemia-free state) outcome and 4 of the 7 achieved cCR (3 CR with full hematologic recovery, and 1 CRh (CR with partial hematologic recovery)). 4 of 4 cCR patients were MRD- (Measurable Residual Disease Negative) as assessed by local standard of care....SENTI-202 was detected in all treated patients, consistent with other allogeneic CAR NK cell therapy PK profiles, namely with modest expansion in the first 14 days in the periphery followed by clearance from peripheral blood."

P1 data • Acute Myelogenous Leukemia

Senti Bio to Host Conference Call and Webcast to Discuss SENTI-202 Clinical Data Being Presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 on Monday, April 28th at 8:30 AM ET (GlobeNewswire) - "Senti Biosciences, Inc...today announced that it will host a conference call and webcast to discuss the new SENTI-202 Phase 1 clinical data being presented at the American Association for Cancer Research (AACR) Annual Meeting on Monday, April 28, 2025 at 8:30 AM ET."

P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Senti Bio to Showcase SENTI-202 Clinical Data and Novel Logic Gated Gene Circuit Mechanism of Action in Oral and Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025 (GlobeNewswire) - "Senti Biosciences, Inc...today announced that three abstracts have been selected for an oral minisymposium and poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025...We are excited to present updated clinical and correlative data from our ongoing SENTI-202 trial, along with detailed preclinical characterization of our Logic Gate technology. The preclinical data shows the EMCN inhibitory CAR (our NOT gate) protects healthy bone marrow cells from on-target off-tumor toxicity in vivo. Taken together, this data continues to support our enthusiasm for the potential of SENTI-202 to treat r/r AML and for Logic Gating, including our unique NOT gates, to be broadly applied to oncology to enhance the selective targeting of cancer while sparing healthy cells that may express the same targets."

Clinical data • Preclinical • Acute Myelogenous Leukemia

Senti Bio Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Pipeline and Corporate Highlights (GlobeNewswire) - "...'With initial data from the clinical trial of SENTI-202, we are getting a glimpse into the potential profile of our gene circuit-enabled CAR-NK therapy for patients with AML. As we look toward 2025, we anticipate sharing additional data from this exciting trial'..."

P1 data • Acute Myelogenous Leukemia

Senti Bio Announces Additional $11.5 Million of Financing (GlobeNewswire) - "The Company intends to use the net proceeds from the offering, together with existing cash, cash equivalents and investments, to fund the continued development of its SENTI-202 program and manufacturing ramp-up, other research and development activities, and for general corporate purposes."

Commercial • Oncology

Senti Biosciences, Inc. Announces Oversubscribed $37.6 Million Private Placement Equity Financing (GlobeNewswire) - "Senti Bio anticipates the gross proceeds from the PIPE financing to be approximately $37.6 million, before deducting offering expenses....The Company intends to use the net proceeds from the offering, together with existing cash, cash equivalents and investments, to fund the continued development of its SENTI-202 program and manufacturing ramp-up, other research and development activities, and for general corporate purposes."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

SENTI-202 Next Steps (GlobeNewswire) - "The Company expects to enroll a total of approximately 20 patients in the Phase 1 trial, based on the current clinical trial design. A higher dose cohort of 1.5 billion CAR+ NK cells/dose is actively enrolling. Additional safety and efficacy data, including initial durability data, are expected to follow in 2025."

P1 data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome