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
Senti Biosciences (Nasdaq: SNTI) has determined the recommended Phase 2 dose (RP2D) for its Phase 1 study of SENTI-202, a first-in-class Logic Gated CAR-NK cell therapy for treating relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML).
The RP2D was established at 1.5 x 109 CAR+ NK cells/dose, administered on Days 0, 7, and 14 of 28-Day Cycles. Early efficacy data shows promising results with 2 of 3 patients achieving composite Complete Remission (cCR) in the preliminary RP2D cohort, and 5 of 7 evaluable patients achieving Overall Response Rate (ORR). All complete remission patients (4 of 4) were MRD-negative, with durability extending to 8+ months.
The company expects to report topline data from the expansion cohort before year-end 2025. SENTI-202 has received FDA Orphan Drug Designation.
Senti Biosciences (Nasdaq: SNTI) ha stabilito la dose raccomandata per la Fase 2 (RP2D) nel suo studio di Fase 1 su SENTI-202, una terapia cellulare CAR-NK Logic Gated di prima classe per il trattamento di neoplasie ematologiche recidivanti/refrattarie, inclusa la leucemia mieloide acuta (AML).
La RP2D è stata fissata a 1,5 x 109 cellule NK CAR+ per dose, somministrate nei giorni 0, 7 e 14 di cicli di 28 giorni. I dati preliminari di efficacia mostrano risultati promettenti con 2 pazienti su 3 che hanno raggiunto la remissione completa composita (cCR) nel primo gruppo con RP2D, e 5 pazienti su 7 valutabili che hanno ottenuto un tasso di risposta globale (ORR). Tutti i pazienti in remissione completa (4 su 4) erano negativi per MRD, con una durata che supera gli 8 mesi.
L'azienda prevede di comunicare i dati principali del gruppo di espansione entro la fine del 2025. SENTI-202 ha ricevuto la designazione di farmaco orfano dalla FDA.
Senti Biosciences (Nasdaq: SNTI) ha determinado la dosis recomendada para la Fase 2 (RP2D) en su estudio de Fase 1 de SENTI-202, una terapia celular CAR-NK Logic Gated de primera clase para el tratamiento de malignidades hematológicas en recaída/refractarias, incluyendo leucemia mieloide aguda (LMA).
La RP2D se estableció en 1.5 x 109 células NK CAR+ por dosis, administradas en los días 0, 7 y 14 de ciclos de 28 días. Los datos iniciales de eficacia muestran resultados prometedores con 2 de 3 pacientes logrando remisión completa compuesta (cCR) en la cohorte preliminar con RP2D, y 5 de 7 pacientes evaluables alcanzando la tasa de respuesta global (ORR). Todos los pacientes en remisión completa (4 de 4) fueron negativos para MRD, con una duración que supera los 8 meses.
La compañía espera reportar datos principales de la cohorte de expansión antes de fin de año 2025. SENTI-202 ha recibido la designación de medicamento huérfano por la FDA.
Senti Biosciences (나스닥: SNTI)는 재발성/불응성 혈액암, 특히 급성 골수성 백혈병(AML) 치료를 위한 최초의 Logic Gated CAR-NK 세포 치료제인 SENTI-202의 1상 연구에서 권장 2상 투여 용량(RP2D)을 결정했습니다.
RP2D는 1.5 x 109 CAR+ NK 세포/용량으로 설정되었으며, 28일 주기의 0, 7, 14일에 투여됩니다. 초기 효능 데이터는 RP2D 예비 코호트에서 3명 중 2명이 복합 완전 관해(cCR)를 달성했고, 평가 가능한 7명 중 5명이 전체 반응률(ORR)을 보이는 등 유망한 결과를 나타냅니다. 완전 관해 환자 모두(4명 중 4명)는 MRD 음성이며, 관해 지속 기간은 8개월 이상입니다.
회사는 2025년 말 전에 확장 코호트의 주요 데이터를 보고할 예정입니다. SENTI-202는 FDA 희귀의약품 지정을 받았습니다.
Senti Biosciences (Nasdaq : SNTI) a déterminé la dose recommandée pour la Phase 2 (RP2D) dans son étude de Phase 1 sur SENTI-202, une thérapie cellulaire CAR-NK Logic Gated de première classe pour le traitement des hémopathies malignes en rechute/réfractaires, y compris la leucémie myéloïde aiguë (LMA).
La RP2D a été fixée à 1,5 x 109 cellules NK CAR+ par dose, administrée les jours 0, 7 et 14 de cycles de 28 jours. Les premières données d'efficacité montrent des résultats prometteurs avec 2 patients sur 3 ayant atteint une rémission complète composite (cCR) dans la cohorte RP2D préliminaire, et 5 patients sur 7 évaluables ayant obtenu un taux de réponse globale (ORR). Tous les patients en rémission complète (4 sur 4) étaient négatifs pour la MRD, avec une durabilité dépassant 8 mois.
L'entreprise prévoit de communiquer les données principales de la cohorte d'expansion avant la fin de l'année 2025. SENTI-202 a reçu la désignation de médicament orphelin de la FDA.
Senti Biosciences (Nasdaq: SNTI) hat die empfohlene Dosis für Phase 2 (RP2D) in seiner Phase-1-Studie von SENTI-202 bestimmt, einer neuartigen Logic Gated CAR-NK Zelltherapie zur Behandlung von rezidivierenden/refraktären hämatologischen Malignomen, einschließlich akuter myeloischer Leukämie (AML).
Die RP2D wurde auf 1,5 x 109 CAR+ NK-Zellen/Dosis festgelegt, verabreicht an den Tagen 0, 7 und 14 eines 28-Tage-Zyklus. Erste Wirksamkeitsdaten zeigen vielversprechende Ergebnisse mit 2 von 3 Patienten, die eine zusammengesetzte komplette Remission (cCR) erreichten in der vorläufigen RP2D-Kohorte, und 5 von 7 bewertbaren Patienten, die eine Gesamtansprechrate (ORR) erzielten. Alle Patienten mit kompletter Remission (4 von 4) waren MRD-negativ, mit einer Ansprechdauer von über 8 Monaten.
Das Unternehmen erwartet, die wichtigsten Daten der Erweiterungskohorte noch vor Ende 2025 zu berichten. SENTI-202 hat die FDA-Orphan-Drug-Designation erhalten.
- 2 of 3 patients achieved composite Complete Remission (cCR) in preliminary RP2D cohort
- Strong Overall Response Rate with 5 of 7 evaluable patients responding
- 100% of cCR patients (4 of 4) achieved MRD-negative status
- Promising durability with longest response at 8+ months
- No dose limiting toxicities observed
- FDA Orphan Drug Designation granted
- Maximum tolerated dose was not reached, which could indicate potential for higher dosing
Insights
Senti Bio's SENTI-202 shows promising efficacy in AML with 4/7 patients achieving complete remission and establishing the recommended Phase 2 dose.
Senti Biosciences has reached a significant clinical milestone by establishing the recommended Phase 2 dose (RP2D) for SENTI-202, their novel Logic Gated CAR-NK cell therapy targeting relapsed/refractory hematologic malignancies. The determined RP2D is 1.5 x 109 CAR+ NK cells/dose administered on Days 0, 7, and 14 of 28-day cycles following lymphodepleting chemotherapy.
The preliminary efficacy data is particularly encouraging in a difficult-to-treat population.
The durability data, while still maturing, shows promise with the longest reported response exceeding 8 months and median duration not yet reached. This suggests potential for sustained remissions, addressing a critical unmet need in AML where relapses are common.
The safety profile appears favorable with no dose-limiting toxicities reported, and the maximum tolerated dose was not reached during dose escalation. This safety profile is particularly important for AML patients who are often elderly or frail from previous treatments.
The FDA's prior grant of Orphan Drug Designation reflects the potential significance of this therapy. With the expansion cohort now enrolling at the established RP2D, the upcoming year-end data readout will be pivotal in determining whether SENTI-202 can advance toward potential registration studies.
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 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, including AML, at multiple sites in the United States and Australia. 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.
“Establishing the RP2D is a pivotal milestone in our clinical development program. This achievement reflects the strength of our preliminary data and positions us to advance into the next phase of development with confidence. We remain focused on the successful execution of the Phase 1 trial and, importantly, advance a potential new treatment option for patients with AML, who remain in urgent need of better therapeutic options,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences.
As previously announced, SENTI-202 was well-tolerated with no dose limiting toxicities and a maximum tolerated dose was not reached. 2 of 3 patients in the preliminary RP2D cohort achieved a composite Complete Remission (cCR), i.e. CR or CR with partial hematologic recovery or CRh; 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 ). All 4 of 4 cCR patients were MRD- (Measurable Residual Disease Negative) as assessed by local standard of care. Median duration of cCR is not reached with longest durability of 8+ months as reported previously.
SENTI-202 was previously granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). For more information about the Phase 1 trial, visit clinicaltrials.gov and reference identifier NCT06325748.
About SENTI-202
SENTI-202 is a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies, such as AML and myelodysplastic syndrome (“MDS”), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE (providing a “kill” signal), which is an activating CAR that recognizes CD33 and/or FLT3. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts and leukemia stem cells, which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE (providing a “protect” signal), which is an inhibitory CAR that is designed to recognize healthy cells and protect those healthy cells from being killed, even if they were to express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15 (providing an “enhance” signal), which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to manufacture SENTI-202 are sourced from selected healthy adult donors. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3-expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic off-the-shelf treatment for AML/MDS patients.
Senti Bio has published SENTI-202 preclinical data demonstrating the potential of Logic Gated CAR-NK cell therapy for the treatment of AML.
About AML
AML is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. It is estimated there were 20,800 new cases of AML in the United States in 2024. The five-year survival rate for these patients is approximately
About Senti Bio
Senti Bio is a biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging its synthetic biology platform to engineer Gene Circuits into new medicines with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. The Company’s wholly-owned pipeline is comprised of cell therapies engineered with Gene Circuits to target challenging liquid and solid tumor indications. Senti’s Gene Circuits have been shown preclinically to work in both NK and T cells. Senti Bio has also preclinically demonstrated the potential breadth of Gene Circuits in other modalities and diseases outside of oncology, and continues to advance these capabilities through partnerships.
Forward-Looking Statements
This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s growth, strategy, progress and timing of its clinical trials for SENTI-202;the timing of availability of data from the ongoing Phase 1 clinical trial of SENTI-202; the ability of any product candidate to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; expectations regarding the anticipated dosing of patients and availability of data from clinical trials, and the timing thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s clinical trial start up, clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of the grant from CIRM, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Availability of Other Information About Senti Biosciences, Inc.
For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (@SentiBio) and LinkedIn (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
SNTI@jtcir.com
FAQ
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