CERo Therapeutics Doses Second Acute Myeloid Leukemia Patient with CER-1236

Second patient in the first cohort is now advancing through protocol-defined evaluations as Company provides promising update on first patient pharmacokinetic results

SOUTH SAN FRANSCISCO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: 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 second patient in the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML).  The patient was dosed at the in Denver, Colorado, with Yazan Migdady, M.D., an associate member physician at CBCI acting as principal investigator for the study.  With more than seven days passed following the second patient’s infusion, monitoring continues for key safety, tolerability, and efficacy endpoints. 

Dr. Migdady noted, “The dosing of the second patient in this Phase 1 first-in-human trial is an important indicator, representing a key clinical development milestone for CER-1236, a novel autologous CAR-T therapeutic candidate targeting TIM 4L.  We believe that CER-1236 may be an important advancement in cancer immunotherapy and this second patient reflects steady progress in our clinical evaluation.  We are now conducting protocol-specified evaluations of safety, pharmacodynamic, pharmacokinetic, and efficacy endpoints, and expect to communicate progress over the course of the study.”

Previously CERo reported that the first patient treated in CertainT-1 had no dose-limiting toxicities during the 28-day DLT observation period. Further analysis of CER-1236 pharmacokinetics in this patient reveals that the therapy of infused cells expanded (e.g., the cell number multiplied) as expected upon infusion, reaching a peak at 14 days post infusion with a 20.8-fold expansion of infused cells. These are early insights into how CER-1236 functions in AML patients, and CERo will be monitoring pharmacokinetics in subsequent patients.

The first-in-human, multi-center, open label, Phase 1/1b study 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 the 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).

CERo CEO Chris Ehrlich said, “We are encouraged that in our very first patient treated we saw rapid and significant expansion in CER-1236 cells after infusion, a positive sign that we’re on the right track in our Phase I study, based on the extensive experience and history of the clinical development of CAR T cells.  We continue to believe that CER-1236 is a novel approach to treating cancer, and we are grateful for the participation of our first and second patients, and to the many people who have worked tirelessly to reach this milestone, including our CERO team, our consultants and study sites.  We look forward to discussing additional outcomes, which we anticipate will validate the scientific work performed to date with CER-1236.”

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.

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Contact:

Chris Ehrlich

Chief Executive Officer

Investors:

CORE IR