Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 154

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 154
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ancies, we believe CER-1236 will be active in both hematological malignancies and solid tumors. On November 14, 2024, we received notice from the FDA that the Investigational New Drug Application (“IND”) was cleared after being put on a brief clinical hold due to insufficient nonclinical data to adequately judge off target toxicity. The clinical hold was lifted after additional in vitro experiments were performed. We submitted a second IND application for the investigation of CER-T cell therapy in non-small cell lung cancer (“NSCLC”) and ovarian cancer, which was accepted by the FDA on March 27, 2025. We anticipate initiation of a Phase 1 study in NSCLC and ovarian cancer in the first quarter of 2026. In May 2025, we initiated our Phase 1 clinical trial, designed to evaluate the safety, potential therapeutic utility and applicable dose of CER-1236 in patients with acute myeloid leukemia (“AML”). 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 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 and serious adverse events, incidence of dose limited toxicities and estimation of overall response rate, complete response, composite complete response, and measurable residual disease. Secondary outcome measures include pharmacokinetics. To date we have successfully manufactured and administered cell products for four patients. After dosing and completion of a 28-day dose-limiting toxicity monitoring period, the dose escalation committee determined that there were no safety concerns and we could advance to the next dose for the fourth patient. The fourth patient received an initial dose of CER-1236 at twice the initial dose of the patients in the first cohort, with a follow-on second identical dose 48 hours later. The fifth patient is anticipated to be treated in February 2026. The ability to enhance the activity of T cells against human cancers through genetic engineering has been among the most significant advances in cancer therapy in the last decade. One of the more promising therapeutic uses of T cells to emerge has been CAR-T cell technology. However promising CAR-T cell