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).