CERo Therapeutics Holdings, Inc. Announces First Patient Completes Dose-Limiting Toxicity Observation Period with No Reported DLTs in Phase 1 Trial of CER-1236
- First patient showed no dose-limiting toxicities during 28-day observation period
- Second AML patient already identified and consented for trial participation
- Company plans to expand trials to solid tumors later in 2025
- CER-1236 represents a first-in-class biologic targeting a novel pathway
- Early stage Phase 1 trial with only one patient evaluated so far
- Efficacy data not yet available
- Long development timeline ahead with multiple trial phases required
Insights
CERo's first patient in Phase 1 trial shows no toxicity from novel cancer therapy CER-1236, a positive early safety signal.
CERo Therapeutics has reached a meaningful early milestone in their Phase 1 clinical development program for CER-1236. The first patient treated in their trial has successfully completed the critical 28-day dose-limiting toxicity (DLT) observation period without experiencing any dose-limiting toxicities. This represents a positive initial safety signal for their novel immunotherapy approach.
The significance here lies in CER-1236's novel mechanism of action - it's a first-in-class therapy targeting TIM4L with phagocytic mechanisms, essentially a completely new approach to cancer treatment. First-in-human trials of novel mechanisms carry heightened safety risks, so this clean initial safety profile is particularly encouraging.
While this is very early data from just a single patient, it enables trial progression - the company has already identified and consented a second AML patient for treatment. The trial is following the standard Phase 1 oncology design with dose escalation to determine safety and maximum tolerated dose before moving to efficacy-focused expansion cohorts.
The company is also preparing to initiate a separate trial of CER-1236 in solid tumors later this year, suggesting confidence in their platform. For a novel immunotherapy approach, demonstrating both safety and manufacturing feasibility (they noted successful manufacturing from an AML patient) are critical early hurdles that appear to have been cleared with this first patient.
However, investors should understand this represents just the first step in a long clinical development process, with no efficacy data yet available and safety confirmed in only a single patient at what is likely a conservative starting dose.
SOUTH SAN FRANSCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an immunotherapy company developing the next generation of engineered T cell therapeutics targeting TIM4L with phagocytic mechanisms, today announces the completion of the initial evaluation of the first patient in its Phase 1 clinical trial of lead compound CER-1236. Following an evaluation from the trial’s Dose Escalation Safety Committee, preliminary results show that the patient demonstrated no dose limiting toxicity. The Company anticipates dosing the second patient in the cohort shortly.
CERo CMO Robert Sikorski MD., PhD. noted, “The first patient experienced no dose-limiting toxicities during the planned 28-day observation period following the successful manufacturing of CER-1236 from an AML patient. A second AML patient has been identified and has provided informed consent for participation in the trial.”
CERo CEO Chris Ehrlich added, “Given that CER-1236 is a first-in-class biologic targeting a previously unexplored pathway, each milestone reached is significant. We remain focused on progressing methodically through each phase of this trial and are preparing to initiate our second trial of CER-1236 in solid tumors later this year. We continue to believe CER-1236 holds significant potential as a novel approach in cancer therapy and look forward to providing future updates.”
CER-1236 is currently in Phase 1 clinical trials for AML. The first-in-human, multi-center, open label, Phase 1/1b study, titled, “Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1),” is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to 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 that this differentiated activity of CER-T cells could afford greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy. In April 2025, CERo initiated clinical trials for its lead product candidate, CER-1236, targeting TIM4L in both hematologic malignancies and 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 CERo’s ability to regain 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 its subsequent Quarterly Reports on Form 10-Q, 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
cehrlich@cero.bio
Investors:
CORE IR
investors@cero.bio
FAQ
What are the initial results of CERO's Phase 1 trial for CER-1236?
What type of cancer is CER-1236 being tested for in the Phase 1 trial?
What are the primary endpoints of CERO's CertainT-1 trial?
When will CERO begin testing CER-1236 in solid tumors?
What makes CER-1236 unique as a cancer treatment?
