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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

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Senti Biosciences (SNTI) has released a mechanism of action video for SENTI-202, their first-in-class off-the-shelf CAR NK cell therapy. The therapy targets CD33 and/or FLT3-expressing hematologic malignancies like AML and MDS. SENTI-202 features three key components: an OR Logic Gate targeting leukemia cells, a NOT Logic Gate protecting healthy cells, and calibrated IL-15 release enhancing immune response. The ongoing Phase 1 trial shows promising results with no dose-limiting toxicities. At the preliminary recommended Phase 2 dose, 2 of 3 patients achieved complete remission. Overall, 5 of 7 evaluable patients showed response, with 4 achieving complete remission. All complete remission patients remain in remission with 4+ to 8+ months of follow-up.
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Positive

  • Promising Phase 1 trial results with no dose-limiting toxicities
  • High response rate: 5 of 7 evaluable patients achieved overall response
  • Strong complete remission rate: 4 of 7 patients achieved complete remission
  • All complete remission patients remain in remission (4-8+ months)
  • Therapy targets ~95% of AML patients through CD33/FLT3 expression
  • All complete remission patients (4 of 4) achieved MRD-negative status

Negative

  • Small patient sample size in preliminary results
  • Relatively short follow-up period (4-8+ months)

News Market Reaction – SNTI

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-0.30% News Effect

On the day this news was published, SNTI declined 0.30%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

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

Access video here

SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announces the release of its new animated video for its lead asset in development, SENTI-202. The video can be accessed here.

SENTI-202 is the Company’s 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:

  • OR Logic Gate “Kills” leukemia blasts and LSCs via CD33 OR FLT3 activating CAR (aCAR)​
    • CD33 and/or FLT3 expressed in ~95% of AML patients with CD33 being predominantly expressed on bulk blasts and FLT3 on LSCs​
  • NOT Logic Gate “Protects” healthy HSC/HSPCs from ‘off-tumor, on-target’ effects​
    • Protection of HSC/HSPCs via Endomucin (EMCN) inhibitory CAR (iCAR), even when they express CD33 and/or FLT3​
    • EMCN found predominantly on healthy HSC/HSPC surface, rarely on AML blasts ​
  • Calibrated release IL-15 “Enhances” SENTI-202 and host immune cell activity and persistence

Senti Bio is currently enrolling adult patients with relapsed/refractory (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 (NCT06325748).

Positive preliminary results from the ongoing Phase 1 trial as well as correlative data from patients and preclinical data supporting Logic Gate mechanism of action were recently presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presented data demonstrated SENTI-202 was well-tolerated with no dose limiting toxicities and a maximum tolerated dose was not reached. The preliminary recommended Phase 2 dose (RP2D) was identified based on the totality of clinical data, including efficacy, as 1.5 x 109 CAR NK cells administered on Days 0,7,14 in 28-day Cycles following lymphodepleting chemotherapy. 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. All cCR patients continue in remission with follow-ups ranging from 4+ to 8+ months ongoing.

The SENTI-202 animated mechanism of action video is now available on the Company’s website, here.

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

What are the key results from SNTI's SENTI-202 Phase 1 trial?

The Phase 1 trial showed SENTI-202 was well-tolerated with no dose-limiting toxicities. 5 of 7 evaluable patients achieved overall response, with 4 achieving complete remission. All complete remission patients remain in remission with 4-8+ months follow-up.

How does Senti Bio's SENTI-202 therapy work?

SENTI-202 uses three components: an OR Logic Gate targeting CD33/FLT3-expressing cancer cells, a NOT Logic Gate protecting healthy cells via EMCN recognition, and calibrated IL-15 release to enhance immune response.

What is the recommended Phase 2 dose for SENTI-202?

The preliminary recommended Phase 2 dose is 1.5 x 109 CAR NK cells administered on Days 0,7,14 in 28-day cycles following lymphodepleting chemotherapy.

What types of cancer does SENTI-202 target?

SENTI-202 targets CD33 and/or FLT3-expressing hematologic malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

What percentage of AML patients could potentially benefit from SENTI-202?

SENTI-202 could potentially benefit approximately 95% of AML patients, as CD33 and/or FLT3 are expressed in ~95% of AML patients.
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Biotechnology
Biological Products, (no Diagnostic Substances)
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SOUTH SAN FRANCISCO