Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 166

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 166
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6. In preclinical studies, we have observed CER-1236 to display attractive functional capabilities and product characteristics, among which are:

| ● | target-dependent activation,                                                   
 cytotoxicity, anti-tumor cytokine production, and high proliferative capacity; |

| ● | tumor cell phagocytosis; |

| ● | distinct transcriptome, cytokine                                                                                       
 and chemokine signatures that substantiate the complementary activity of both the innate and adaptive immune response; |

| ● | enhanced antigen acquisition, 
 processing and presentation;  |

| ● | no evidence of T cell exhaustion 
 despite repeated challenges;     |

| ● | no observed off-target or off-tumor 
 toxicities;                         |

| ● | expression and maintenance                                                                                                     
 of diverse T cell populations, including naïve and memory cells, likely indicative of response persistence and durability; and |

| ● | well defined and scalable manufacturing 
 protocols.                              |

94 We have designed CER-1236 to align with components included in the current generation of conventional CAR-T configurations by fusing the external domain of TIM-4, a phagocytic receptor, with intracellular signaling domains from T cells and innate immune cells. TIM-4 harbors endogenous phagocytic capacity through its binding to the pro-phagocytic “eat-me” signal TIM-4-L. CER-1236’s intracellular signaling domains, including TLR2, CD28 and CD3ξ motifs, are designed to augment both TIM-4 mediated phagocytosis and cytotoxic T cell function. Another similarity between conventional CAR-T therapeutic formats and our CER-T design is the delivery vehicle used in transduction. As is found in many approved CAR-T therapies, our CER-T technology also employs a lentiviral vector to facilitate gene delivery to patient-derived T cells. A schematic of the structural elements of CER-1236 is presented below. Schematic of CER-1236 Abbreviations: TIM-4 = ectodomain of the T cell immunoglobulin mucin domain protein 4; TLR2 = toll-like receptor 2. CER-1236 employs an innovative mechanism of action CER-1236 is an autologous T cell therapy candidate designed to target TIM-4-L through the external domain of the prophagocytic receptor TIM-4 protein. This therapeutic construct was developed to combine adaptive T cell killing activity with phagocytic clearance and antigen presentation activity to create T cells with