CERo Therapeutics Holdings, Inc. Poised to Initiate Enrollment of Phase 1 Trial of CER-1236 in AML Following Positive FDA Review of Manufacturing

Rhea-AI Summary

CERo Therapeutics (NASDAQ: CERO) has received positive FDA review on Chemistry, Manufacturing and Controls (CMC) amendment to its IND for CER-1236, marking the final commitment before initiating patient dosing. This development reduces manufacturing timeline by approximately one week.

The company remains on schedule to begin dosing initial subjects in first half of 2025 for their Phase 1/1b clinical trial targeting relapsed/refractory measurable residual disease positive acute myeloid leukemia. The study will evaluate safety and preliminary efficacy through a two-part process: dose escalation followed by expansion phase.

Additionally, CERo's abstract has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) conference, scheduled for May 30-June 5 in Chicago.

Positive

• FDA approval of CMC amendment reduces manufacturing timeline by one week
• On track for Phase 1 trial initiation in H1 2025
• Abstract accepted for presentation at 2025 ASCO conference

Negative

• None.

Insights

Biotech Regulatory Analyst

CERo Therapeutics' FDA clearance on their Chemistry, Manufacturing and Controls (CMC) amendment represents a meaningful regulatory milestone that removes a critical hurdle before clinical trial initiation. This positive review specifically shortens manufacturing timelines by approximately one week and completes their final commitment to the FDA prior to patient dosing.

For early-stage biotechs, these regulatory interactions are crucial inflection points that can either accelerate or significantly delay development timelines. The fact that CERo avoided additional FDA information requests demonstrates solid regulatory execution and CMC preparation—areas where many early-stage companies stumble.

While this isn't a therapeutic efficacy signal, it derisks their path to initial clinical data. For context, their CER-1236 candidate targets acute myeloid leukemia (AML) using engineered T cells with phagocytic mechanisms—a differentiated approach in the competitive cell therapy landscape.

The upcoming trial's design is standard for cell therapies, with dose escalation followed by expansion cohorts. The abstract acceptance at ASCO provides a valuable scientific validation platform, though the market impact will depend on what data they actually present.

The milestone keeps CERo on track for first-half 2025 dosing, providing a clear catalyst timeline for investors to monitor, with initial safety data likely emerging 3-6 months after first patient dosing.

Oncology Clinical Development Expert

CERo's approach with CER-1236 employs an intriguing mechanistic innovation in cell therapy for AML by focusing on phagocytic mechanisms rather than the cytotoxic approach used in approved CAR-T therapies. This differentiation could potentially address resistance mechanisms seen with traditional approaches.

The trial design focusing on relapsed/refractory AML patients with measurable residual disease (MRD) is strategically sound. MRD-positive AML represents a critical unmet need where early intervention can potentially prevent full relapse. The endpoints—including MRD clearance—are clinically meaningful and could potentially support an accelerated approval pathway if results are compelling.

From a clinical operations perspective, having cleared all regulatory CMC hurdles before patient dosing suggests potential for smoother trial execution. Manufacturing consistency is particularly critical in cell therapies, where process changes can significantly impact clinical outcomes.

The two-part study structure allows for both safety characterization and preliminary efficacy signals. The inclusion of pharmacokinetic measurements will provide valuable insights into cell persistence—a key determinant of durable responses in cellular immunotherapies.

While still early-stage, this positions CERo to generate initial proof-of-concept data in a disease where new therapeutic approaches are urgently needed, as AML remains one of the most challenging hematologic malignancies with poor outcomes in relapsed settings.

Company reports acceptance of an abstract at the 2025 American Society of Clinical Oncology (ASCO) conference; Continues to be on track to dose first patient in first half of 2025

SOUTH SAN FRANSCISCO, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the Company has received positive review from the U.S. Food and Drug Administration (FDA) on an amendment to its IND around Chemistry, Manufacturing and Controls (CMC), which marks completion of the Company’s final commitment to FDA prior to initiating patient dosing and shortens the manufacturing timeline by about a week. With this completion, the Company is on track to meet its anticipated timeline of dosing initial subjects during the first half of 2025.

Chris Ehrlich, CERo Therapeutics CEO added, “This is a key completion as we ramp up for initiating our clinical trial of CER-1236. Very often there are additional delays prior to initiating a trial, including manufacturing, chemistry and other follow-on information that FDA may request at the time of or following the clearance of an IND. We have worked diligently to ensure continued progress with the FDA, avoiding additional delays. This is due to our fantastic team and top-notch consultants and partners, including UC Davis, our manufacturing partner, that have been working alongside us on this process. In the meantime, we received acceptance from the American Society of Clinical Oncology (ASCO) of an abstract, which we expect to present at the annual conference in Chicago May 30-June 5. We will provide more updates on that presentation, as well as updating on our program development in the near term.”

The first-in-human, multi-center, open label, Phase 1/ 1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory measurable residual disease positive acute myeloid leukemia. The two-part study will begin with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to further evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK).

About CERo Therapeutics Holdings, Inc.

CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2025 for hematological malignancies.

Forward-Looking Statements

This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the product development and manufacturing of CER-1236, financial position, business strategy and the plans and objectives of management for future operations of CERo the timing and completion of the reverse stock split, and the acceptance and implementation of its proposed plan of compliance with Nasdaq continued listing standards. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.

Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact:
Chris Ehrlich
Chief Executive Officer
chris@cero.bio

Investors:
CORE IR
investors@cero.bio

FAQ

What is the timeline for CERo Therapeutics (CERO) Phase 1 trial of CER-1236?

CERo plans to begin dosing initial subjects in the first half of 2025, with manufacturing timeline shortened by approximately one week following FDA's positive CMC review.

What are the primary outcome measures for CERo's (CERO) CER-1236 clinical trial?

Primary outcomes include monitoring adverse events (AEs), serious adverse events (SAEs), dose toxicities, overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD).

What type of cancer is CERo Therapeutics (CERO) targeting with CER-1236?

CER-1236 targets relapsed/refractory measurable residual disease positive acute myeloid leukemia (AML).

When will CERo Therapeutics (CERO) present their research at ASCO 2025?

CERo will present their accepted abstract at the ASCO annual conference in Chicago, scheduled for May 30-June 5, 2025.