CERo Therapeutics Holdings, Inc. to Present Poster on Lead Program, CER-1236, at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting

Rhea-AI Summary

CERo Therapeutics Holdings (Nasdaq: CERO) has announced its upcoming presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago from May 30-June 3, 2025. The company will present a poster titled 'First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-L in acute myeloid leukemia (CertainT-1).'

The company is launching a Phase 1/1b clinical trial to evaluate their lead program CER-1236, a novel immunotherapy treatment for acute myeloid leukemia. The study will focus on patients with relapsed/refractory disease, measurable residual disease, or TP53 gene mutations.

The two-part study includes:

• Dose escalation phase to determine highest tolerated dose
• Expansion phase evaluating safety and efficacy

Primary outcomes will measure adverse events, toxicities, overall response rate, complete response, and measurable residual disease, with secondary focus on pharmacokinetics.

SOUTH SAN FRANCISCO, Calif, April 25, 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 it will be presenting a poster at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting to be held May 30-June 3, 2025 at McCormick Place, Chicago, Ill.

The poster is titled, “First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-L in acute myeloid leukemia (CertainT-1).”

Chris Ehrlich, CERo Therapeutics’ CEO, commented, “We look forward to the opportunity to discuss our study protocol at one of the most prestigious oncology conferences in the world. We believe that CER-1236 presents a unique approach to treating cancer utilizing the patient’s immune system and a novel target that we anticipate may alter how doctors currently approach cancer therapy.”

The Company is currently initiating its first-in-human, multi-center, open-label, Phase 1/1b study designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, has measurable residual disease, or has a mutation of the TP53 gene. The two-part study will begin with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include the incidence of adverse events (AEs) and serious adverse events (SAEs), the 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 as well as for certain solid tumors.

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 financial position, business strategy and the plans and objectives of management for future operations of CERo and the 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 15, 2025, 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 CERo Therapeutics' new cancer treatment CER-1236 targeting?

CER-1236 is targeting TIM-4-L in acute myeloid leukemia using autologous chimeric engulfment receptor T-cell therapy.

When will CERO present their CER-1236 clinical trial results at ASCO 2025?

CERo Therapeutics will present their poster at the ASCO Annual Meeting between May 30-June 3, 2025, at McCormick Place, Chicago.

What type of patients will be eligible for CERo's Phase 1/1b CER-1236 trial?

The trial will include acute myeloid leukemia patients who have relapsed/refractory disease, measurable residual disease, or TP53 gene mutations.

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

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

How is CERo Therapeutics' CER-1236 different from traditional cancer treatments?

CER-1236 represents a unique approach using the patient's immune system and phagocytic mechanisms, targeting a novel marker that could change current cancer therapy approaches.