Study will advance into expanded patient populations with myelodysplastic syndrome (MDS) and myelofibrosis (MF)
SOUTH SAN FRANCISCO, Calif., April 14, 2026 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB: CERO) ("CERo" or the "Company") an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces it has dosed the third patient in the second cohort (sixth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies. The patient had MDS that evolved to acute myeloid leukemia (AML). The trial was recently expanded to include earlier forms of MDS and myelofibrosis (MF).
The study continues to progress in accordance with protocol, with patients undergoing monitoring for safety, pharmacokinetics, pharmacodynamics, and clinical activity. With more than seven days of follow-up completed after the most recent infusion, CERo continues to evaluate key endpoints across dose levels as it advances through dose escalation.
As previously presented at the February Tandem Meetings in Salt Lake City, CER-1236 has demonstrated no reported cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, and no dose-limiting toxicities observed during the 28-day assessment window. Investigators also reported in vivo cell expansion, with peak levels observed between days 10 and 14 following infusion. Additionally, as previously reported, a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level achieved 72 consecutive days of platelet transfusion independence. These findings informed the protocol amendment expanding enrollment into patients with MDS and MF.
Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "This is the third patient in the cohort, and completion of the dose-limiting toxicity evaluation period may enable further dose escalation in accordance with the protocol. We continue to evaluate the safety profile and early clinical data as CER-1236 is studied in patient populations with significant unmet need."
The first-in-human, multi-center, open-label Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236. The trial was initially focused on AML patients, including those with relapsed/refractory disease, measurable residual disease, or newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent MDS (TD-MDS), high-risk MDS (HR-MDS), and post-JAK inhibitor myelofibrosis (MF). Primary endpoints include safety and tolerability, while secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD).
CERo Chief Executive Officer Chris Ehrlich added, "Dosing our sixth patient and expanding into MDS represents continued execution of the CERTAIN-T trial and an important milestone for CERo. We believe CER-1236 has the potential to address multiple hematologic malignancies, and we look forward to further advancing the study and sharing additional clinical updates."
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 has commenced clinical trials for its lead product candidate CER-1236 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 financial position, business strategy and the plans and objectives of management for future operations of CERo. 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 most recent Annual Report on Form 10-K and 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
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
