CERo Therapeutics Advances Toward Clinical Trial Initiation for Novel Immunotherapy
Company Announces FDA Milestone and ASCO Abstract Acceptance, Targeting Patient Dosing in Early 2025
FDA Approval Advances CER-1236 Clinical Trial Preparations
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO), an innovative biotech company specializing in engineered T cell immunotherapies, has reached a significant milestone by securing positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application amendment. This amendment addressed key Chemistry, Manufacturing, and Controls (CMC) components, marking completion of the company’s final regulatory pre-requisites before patient dosing can begin. With this approval, CERo has successfully shortened its manufacturing timeline by approximately one week and remains on schedule to initiate dosing in the first half of 2025.
Chris Ehrlich, CEO of CERo Therapeutics, emphasized the importance of this achievement, noting that FDA review processes often introduce unexpected delays due to additional data requests related to manufacturing or chemistry. “Our dedicated team, alongside leading consultants and partners such as UC Davis and our manufacturing collaborators, has worked diligently to navigate these challenges and maintain momentum,” Ehrlich stated. He also shared that an abstract submitted by CERo has been accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) annual conference taking place in Chicago from May 30 to June 5, underscoring the growing recognition of their technology’s potential.
Overview of the CER-1236 Clinical Trial
The upcoming clinical study is a first-in-human, multi-center, open-label Phase 1/1b trial designed to evaluate both the safety and preliminary efficacy of CER-1236 for patients with relapsed or refractory acute myeloid leukemia (AML) who display measurable residual disease (MRD). The trial will proceed in two stages: an initial dose-escalation phase aimed at identifying the highest tolerated dose and establishing the recommended dose for subsequent studies, followed by an expansion phase focused on further assessing safety and therapeutic effectiveness.
Key parameters under investigation include the frequency and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities. Efficacy measures comprise overall response rate (ORR), complete response (CR), composite complete response (cCR), and MRD status. Secondary endpoints will study the pharmacokinetics (PK) of CER-1236 to understand how the therapy behaves within the body.
Innovative Platform and Therapeutic Potential
CERo Therapeutics is pioneering a distinctive approach to cancer immunotherapy by engineering T cells to harness both innate and adaptive immune features within a single treatment. Unlike traditional chimeric antigen receptor T cell (CAR-T) therapies, CERo’s platform integrates phagocytic mechanisms into T cells through a construct the company calls Chimeric Engulfment Receptor T cells, or CER-T. This novel design enables T cells not only to recognize and target cancer cells but also to actively engulf and destroy them.
The company believes this breakthrough has the potential to expand therapeutic applications beyond currently approved CAR-T treatments, offering promise across both hematological malignancies and solid tumors. CER-1236, the lead product candidate, represents the forefront of this technology and is positioned to begin clinical evaluation for hematologic cancers in 2025.
Forward-Looking Considerations
CERo’s communications contain forward-looking statements related to product development, regulatory processes, business strategies, and future operations. These projections involve inherent risks and uncertainties that may cause actual outcomes to differ materially from expectations. Factors impacting results include FDA review timelines, manufacturing challenges, clinical trial data, and market conditions. Investors and stakeholders are advised to consider these risks thoroughly, as outlined in the company’s filings with the Securities and Exchange Commission.
CERo does not undertake an obligation to publicly update any forward-looking statements except as required by law, emphasizing the importance of reviewing all relevant disclosures when evaluating the company’s prospects.
About CERo Therapeutics Holdings, Inc.
CERo Therapeutics is dedicated to advancing next-generation immunotherapies for cancer treatment by creating engineered T cell products that leverage both the innate and adaptive arms of the immune system. By incorporating novel cellular programming that activates phagocytic pathways, CERo aims to produce more effective and broadly applicable therapies to combat both blood cancers and solid tumors.
Contact Information
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Chris Ehrlich, Chief Executive Officer
Email: [email protected] - Investor Relations
Email: [email protected]
CERo Therapeutics remains committed to transforming cancer care through innovative immunotherapy, with clinical development activities advancing steadily in 2025.