Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 180

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 180
---
 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. Following the dosing and observation period for the third patient, the dose escalation safety committee determined that the fourth patient could receive a higher dose. The fourth patient was dosed in October 2025. . 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. 107 Certain T-1 study design in relapsed and refractory AML Certain T-2 study design in ovarian and non-small cell lung cancer 108 Manufacturing Strategy The manufacture of product candidates derived from our autologous CER-1236 T cells involves the same type of equipment, materials and protocols already used in the manufacture of currently FDA-approved CAR-T cell therapies, which we believe will provide us numerous benefits. CER-1236 cell product is being manufactured using an automated closed process, with product manufacture continuous from bulk harvested cells through to cryopreserved drug product bags. There are multiple factors involved in the manufacturing process needed to ensure proper CER-T cell cryopreservation both preceding and following freezing, including the thawing process and post-thaw handling prior to patient administration. These factors are well understood and procedures have been identified to optimize yield, activity, stability and consistency. In addition, we may be able to take advantage of the increasing regulatory familiarity with these established protocols. Our expected manufacturing process embraces a fully automated, closed-system design intended to minimize exposure to potential contaminants and ensure consistent successful manufacture of the product. The product is being manufactured in a contract manufacturing facility which maintains a quality system compliant with current Good Manufacturing Practice (“cGMP”) requirements. Lentivirus containing CER-1236 will be produced following a cGMP process using cGMP plasmids. We have entered into a contract manufacturing agreement related to the production of drug product for our clinical trials, and we anticipate entering into similar arrangements regarding plasmid, viral vector and final drug product manufacture for drug product to be used in subsequent clinical trial phases in the future. We intend to advance related process development work both internally