Senti Bio Receives Additional $1.0 Million Tranche from California Institute for Regenerative Medicines (CIRM) Grant for Advancing Clinical Development of SENTI-202

Rhea-AI Summary

Senti Biosciences (NASDAQ: SNTI) has received an additional $1.0 million from the California Institute for Regenerative Medicine (CIRM) after achieving clinical study enrollment milestones. This brings the total received to $7.4 million of the $8.0 million grant supporting SENTI-202 development.

SENTI-202, a first-in-class Logic Gated off-the-shelf CAR-NK cell therapy, targets CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy bone marrow cells. In its ongoing Phase 1 trial, preliminary results showed the therapy was well-tolerated with no dose-limiting toxicities. The preliminary recommended Phase 2 dose was set at 1.5 x 109 CAR NK cells.

Notable efficacy results include: 2 of 3 patients achieving composite Complete Remission (cCR) in the preliminary RP2D cohort, 5 of 7 patients achieving Overall Response Rate across all dose levels, and 4 of 4 cCR patients achieving MRD-negative status, with the longest response lasting 8+ months.

Positive

• Positive preliminary Phase 1 results with no dose limiting toxicities observed
• Strong efficacy data with 71% (5/7) overall response rate across all dose levels
• 100% (4/4) of complete remission patients achieved MRD-negative status
• Longest complete remission duration ongoing at 8+ months
• Additional $1.0M funding received from CIRM grant, totaling $7.4M of $8.0M grant

Negative

• None.

Insights

Oncology & Biotechnology Specialist

Senti Bio received $1M from CIRM grant after meeting enrollment milestones, with promising early Phase 1 results for their leukemia treatment SENTI-202.

Senti Biosciences has secured an additional $1 million from the California Institute for Regenerative Medicine (CIRM) after achieving enrollment milestones in their SENTI-202 clinical trial. This brings their total received funding to $7.4 million of an $8 million grant, demonstrating continued institutional confidence in their clinical progress.

The company's lead candidate, SENTI-202, represents a significant technological advance as a first-in-class Logic Gated CAR-NK cell therapy. The treatment employs sophisticated gene circuit technology designed to selectively target CD33 and/or FLT3-expressing blood cancers while sparing healthy bone marrow cells - addressing a critical challenge in treating acute myeloid leukemia (AML).

The preliminary Phase 1 data presented at AACR 2025 is particularly encouraging. At the recommended Phase 2 dose, 67% (2/3) of patients achieved a composite Complete Remission (cCR). Across all dose levels, 71% (5/7) of evaluable patients demonstrated objective responses, with 57% (4/7) achieving cCR. Notably, all four cCR patients reached MRD-negative status (Measurable Residual Disease Negative), with the longest response duration at 8+ months and ongoing.

The safety profile appears favorable with no dose-limiting toxicities reported, and the maximum tolerated dose was not reached. The preliminary recommended Phase 2 dose has been identified as 1.5 x 10⁹ CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles following lymphodepleting chemotherapy.

These early results suggest that SENTI-202 may offer meaningful clinical benefit in a difficult-to-treat patient population. For a Phase 1 study, achieving multiple complete remissions with MRD negativity is noteworthy, particularly in relapsed/refractory AML where treatment options remain limited and outcomes are typically poor.

SENTI-202 currently being evaluated in Phase 1 study for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia

SOUTH SAN FRANCISCO, Calif., May 22, 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 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, a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, 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.

“We are grateful for the continued support of the CIRM as we continue to rapidly enroll into our SENTI-202 clinical trial. We are committed to advancing this important program forward and based on the recently presented positive preliminary results, we are becoming more confident in its potential to provide a much-needed treatment option for patients,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences.

SENTI-202 is the Company’s first-in-class off-the-shelf Logic Gated 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 is currently being evaluated in a Phase 1 clinical trial (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 data showed that SENTI-202 was well-tolerated in the patients whose data was presented 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. Two of three patients in the preliminary RP2D cohort achieved a composite Complete Remission (cCR); 5 of the 7 best overall response evaluable patients across all dose levels 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)). Four of four cCR patients were MRD- (Measurable Residual Disease Negative) as assessed by local standard of care, with longest cCR duration of 8+ months ongoing.

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 progress future results from its clinical trials for SENTI-202; and the ability of any product candidate to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data. 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 latest Phase 1 trial results for Senti Bio's (SNTI) SENTI-202 therapy?

In the Phase 1 trial, SENTI-202 showed positive results with 5 of 7 patients achieving overall response rate across all dose levels, and 4 of 4 complete remission patients achieving MRD-negative status. The therapy was well-tolerated with no dose-limiting toxicities.

How much funding has Senti Bio (SNTI) received from CIRM for SENTI-202 development?

Senti Bio has received $7.4 million of an $8.0 million CIRM grant, with the latest tranche being $1.0 million received upon achieving clinical study enrollment milestones.

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 Bio's SENTI-202 target?

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

What is the longest duration of complete remission observed with SENTI-202?

The longest complete remission duration observed is 8+ months and is still ongoing.