Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 161

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 161
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 No perturbation of clinical chemistries was noted. None of the animals experienced weight loss, morbidity or unexpected mortality. No clinically relevant tissue abnormalities were noted at either timepoint at the high dose in any organ evaluated. Overall, these data demonstrate a lack of on-target off-tumor responses and support the safety profile of CER-1236. The potential for off-target toxicity by CER-1236 was also tested against primary human cells or iPSC-derived human cells representing vital organs, including the CNS, heart, lungs, liver, spleen, kidneys, GI tract, and gonads. CER-1236 was co-cultured with these cells and activation was monitored by IFNγ secretion or cytotoxic effect. Over the time points tested, CER-1236 showed potent activation and cytotoxicity against AML cells (Below, top and bottom graphs), but limited activation (Below, top graph) and no cytotoxicity (Below, bottom graph) against any of the human cell types tested. These experiments support the lack of off-target responses by CER-1236 T cells. 101 CER-1236 Clinical Development Strategy Based on the extensive preclinical data that we have assembled regarding the use of CER-1236 T cells to combat cancer, we intend to commence clinical trials with our initial treatment target being patients suffering from relapsed, or refractory AML as well as those subsets who are positive for Minimal Residual Disease and the TP53 mutation. We subsequently intend to expand the clinical development of CER-1236 to include solid tumors such as NSCLC and ovarian cancer. We expect these clinical trials to evaluate the safety, the potential therapeutic utility and applicable dose of CER-1236. In addition, we anticipate that these clinical trials may provide insight into the possible use of CER-1236 to treat an array of hematologic and solid tumors. We believe this drug candidate has the potential to be a therapy for the unmet needs of targeted indications, if approved, and by leveraging the innate immune system’s phagocytic capabilities, could be differentiated by its safety, tolerability, efficacy and clinical benefit over current therapeutic approaches, which have been observed in preclinical studies. None of the abovementioned statements regarding any of our products in development are intended to be a prediction or conclusion of efficacy. No clinical trials on our product candidates have commenced so no conclusions relating to such attributes can be made. Disease backgrounds Acute Myeloid Leukemia Acute My