CERo Therapeutics to Present Late-Breaking Oral Poster Session Highlighting Interim Phase 1 Data from CERTAIN-T Trial Highlighting Platelet Transfusion Independence in a High-Risk MDS/AML Patient
Poster to be presented at Tandem Meeting of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) on February 5, 2026
SOUTH SAN FRANCISCO, Calif., Feb. 04, 2026 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB:CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces a presentation highlighting data to date from the Company's Phase 1 clinical trial, called CERTAIN-T, of its lead compound, CER-1236. Reflective of the Company's recent clinical update, the data highlight results from the first cohort of the trial, featuring a positive safety and tolerability profile, and rapid in vivo cell expansion, with observed approximately 20–70-fold expansion, peaking between days 7–14, followed by prolonged persistence. The data presentation also includes outcomes from an index patient with acute myeloid leukemia (AML) that progressed from myelodysplastic syndrome (MDS), who received a total of four CER-1236 infusions over 5 months at the lowest dose level. Prior to treatment with CER-1236, the patient required frequent platelet transfusions, but after treatment he developed transfusion independence lasting over two months (exceeding the commonly used ≥56-day durability benchmark). The data are being presented at the Tandem Meeting of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) meeting in Salt Lake City, Utah, February 4-6, 2026.
Robert Sikorski, M.D., Ph.D., CERo Therapeutics Chief Medical Officer, commented, "CER-1236 is a first-in-class TIM-4L–targeting cell therapy with early clinical findings demonstrating a favorable safety and tolerability profile to date with no dose-limiting toxicities and no observed cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in the first four treated patients. These early observations support continued clinical evaluation of CER-1236 in myeloid disease settings."
In addition to being available for viewing beginning today, the poster will also be presented the evening of February 5, 2026 during a "Meet the Poster Authors" session. It can also be viewed as part of a Form 8-K filed by the Company that accompanies this press release and can be found here.
The first-in-human, multi-center, open-label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for subsequent expansion, 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-limiting 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). Based on emerging safety data and clinical observations, the trial has recently been amended to include transfusion-dependent myelodysplastic syndromes (TD-MDS), high-risk MDS (HR-MDS), or post-JAK-inhibitor myelofibrosis (MF).
"The acceptance of this late-breaking abstract by an independent review committee highlights the scientific interest in CER-1236 and the progress of the program. While CER-1236 has demonstrated broad potential across multiple tumor types in preclinical studies, the emergence of early clinical observations in AML and MDS underscores the relevance of this approach in myeloid disease settings. The Company continues to advance the CERTAIN-T trial, with the second cohort now underway and enrollment ongoing. We remain focused on the careful and deliberate execution of the dose-escalation phase and the systematic collection of safety data, and we look forward to sharing additional updates with regulatory authorities and other stakeholders as the study progresses." said CERo Therapeutics CEO Chris Ehrlich.
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 integrates key functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body's immune repertoire for more comprehensive tumor targeting. This novel cellular immunotherapy platform is designed to redirect patient-derived T cells toward tumor cells through both adaptive perforin/granzyme pathways and innate engulfment mechanisms, including targeting of the TIM-4 ligand. This employs phagocytic activity to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ("CER-T"). CERo believes the differentiated targeting properties of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has initiated clinical trials for its lead product candidate, CER-1236, for hematologic 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
[email protected]
Investors:
CORE IR
[email protected]
