Senti Bio Announces Execution of Grant Award from California Institute for Regenerative Medicines (CIRM) for Clinical Development of SENTI-202

Rhea-AI Summary

Senti Biosciences (Nasdaq: SNTI) has secured an $8 million grant from the California Institute for Regenerative Medicines (CIRM) to support the clinical development of SENTI-202. This investigational cell therapy is a potential first-in-class Logic Gated off-the-shelf CAR-NK treatment for relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML). The Phase 1 clinical trial (NCT06325748) is currently enrolling adult patients with r/r CD33 and/or FLT3 expressing hematologic malignancies in the United States and Australia. Senti Bio expects to receive the first tranche of the grant in August 2024 and anticipates initial efficacy data by year-end 2024, with durability data following in 2025.

Positive

• Secured $8 million grant from CIRM for clinical development
• Phase 1 clinical trial of SENTI-202 currently enrolling patients
• Initial efficacy data expected by year-end 2024
• Durability data anticipated in 2025

Negative

• None.

Biotechnology Analyst

The $8 million CIRM grant for SENTI-202 is a positive development for Senti Bio, providing important funding for their clinical trials. This financial support demonstrates external validation of their Gene Circuit platform and CAR-NK therapy approach. The ongoing Phase 1 trial for relapsed/refractory hematologic malignancies, including AML, represents a significant market opportunity given the high unmet need in these difficult-to-treat cancers.

The anticipated initial efficacy data by year-end 2024 could be a major catalyst for the company. Positive results could potentially lead to accelerated development timelines and increased investor interest. However, it's important to note that early-stage clinical trials carry inherent risks and the full impact of this news will depend on the trial outcomes.

Financial Analyst

The $8 million grant from CIRM is a non-dilutive funding source, which is particularly valuable for small biotechnology companies like Senti Bio. This additional capital can help extend the company's cash runway without issuing new shares or taking on debt, preserving shareholder value. The phased disbursement of the grant, with the first tranche expected in August 2024, provides near-term financial support for the ongoing clinical trial.

Investors should monitor Senti Bio's cash burn rate and how efficiently they utilize this grant funding. The upcoming efficacy data release could significantly impact the company's valuation and future financing options. Positive results might open doors for partnerships or additional non-dilutive funding, while negative outcomes could pressure the stock price and necessitate alternative financing strategies.

Oncology Specialist

SENTI-202's potential as a first-in-class Logic Gated off-the-shelf CAR-NK therapy is intriguing from a clinical perspective. The focus on CD33 and FLT3 expressing hematologic malignancies, particularly AML, addresses a significant unmet need in oncology. Relapsed/refractory AML patients have treatment options and poor prognoses, making novel approaches like SENTI-202 highly valuable if proven effective.

The multi-center trial across the US and Australia suggests a robust study design. The anticipated efficacy data by year-end 2024 and durability data in 2025 will be important in assessing SENTI-202's potential. If successful, this therapy could offer advantages over current treatments in terms of efficacy, safety and off-the-shelf availability. However, it's essential to temper expectations as many promising therapies face challenges in translating early clinical success to larger trials and real-world settings.

SOUTH SAN FRANCISCO, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced the commencement of a grant award of $8 million from the California Institute for Regenerative Medicines (“CIRM”). Pursuant to the executed agreement with CIRM, the first tranche of the grant award is expected to be received in August 2024.

The CIRM grant will 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 (“r/r”) hematologic malignancies including acute myeloid leukemia (“AML”). The Phase 1 clinical trial of SENTI-202 (NCT06325748) is currently enrolling adult patients with r/r CD33 and/or FLT3 expressing hematologic malignancies, including AML, at multiple sites in the United States and Australia. Initial efficacy data are anticipated by year-end 2024 with initial durability data following in 2025.

About SENTI-202

SENTI-202 is a Logic Gated off-the-shelf 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, the OR GATE, which is an activating CAR that targets CD33 and FLT3. By targeting either or both of these antigens, SENTI-202 could effectively kill both the leukemic blasts and leukemic stem cells that form an important basis for AML disease. Second, the NOT GATE, which is designed to recognize the healthy cells and protect those healthy cells from being killed. Third, the calibrated-release IL-15 technology, which is designed to significantly increase cell persistence, expansion and activity of both the CAR- NK cells and the host immune cells. The NK cells used to construct SENTI-202 are sourced from healthy adult donors, which have been screened based on a set of criteria that reflect manufacturability and product quality, and are then cryopreserved prior to use in manufacturing to minimize variability. Senti Bio is currently enrolling adult patients with r/r CD33 and/or FLT3 expressing hematologic malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogenic 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 Acute Myeloid Leukemia
Acute myeloid leukemia is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. It is estimated there will be 20,800 new cases of AML in the United States in 2024. The five-year survival rate for these patients is approximately 30%. AML is currently treated with chemotherapy, targeted therapies, and/or allogeneic or autologous stem cell transplant. For patients with relapsed or refractory AML, there are few treatment options and median overall survival is typically less than seven months.

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 a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. Senti Bio’s wholly-owned pipeline utilizes off-the-shelf CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio has also preclinically demonstrated the potential breadth Gene Circuits in other modalities, diseases outside of oncology, and continues to advance these capabilities through partnerships with Spark Therapeutics and BlueRock Therapeutics.

About CIRM
CIRM was created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, CIRM, with its team of highly trained and experienced professionals, actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in its portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

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, including the timing and the amount of the grant from CIRM; 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; and expectations regarding its growth, strategy, progress and timing of its clinical trials, including the anticipated dosing of patients and availability of data, 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 Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (“SEC”) on May 9, 2024, and other documents filed by Senti Bio from time to time with the 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 https://www.sentibio.com or follow Senti Bio on X (formerly Twitter) (@SentiBio) and LinkedIn (Senti Biosciences). Investors and others should note that Senti Bio communicates with its investors and the public using its company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, SEC filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that Senti Bio posts on its website or on X (formerly Twitter) or LinkedIn could be deemed to be material information. As a result, Senti Bio encourages investors, the media and others interested to review the information that it posts there on a regular basis. The contents of Senti Bio’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Senti Bio Contact
Investors: investors@sentibio.com
Media: media@sentibio.com

FAQ

What is the purpose of the CIRM grant awarded to Senti Biosciences (SNTI)?

The $8 million CIRM grant is to support the clinical development of SENTI-202, a potential first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for treating relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML).

When is Senti Biosciences (SNTI) expected to receive the first tranche of the CIRM grant?

Senti Biosciences is expected to receive the first tranche of the CIRM grant in August 2024.

What is the current status of the SENTI-202 clinical trial (NCT06325748)?

The Phase 1 clinical trial of SENTI-202 (NCT06325748) is currently enrolling adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML, at multiple sites in the United States and Australia.

When does Senti Biosciences (SNTI) anticipate releasing initial efficacy data for SENTI-202?

Senti Biosciences anticipates releasing initial efficacy data for SENTI-202 by year-end 2024, with initial durability data following in 2025.