Company: CERO
Filing Date: 2025-01-21
Form Type: S-1/A
Source: 0001213900-25-004742
Chunk: 150

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-01-21
Form: S-1/A
Chunk 150
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 We are seeking to exploit the presence of TIM-4-L expressed on the outer cell surface of both hematological malignancies and solid tumors. 90 CER-1236: Our Lead Development Candidate As externally oriented TIM-4-L is present on many cancerous cells regardless of tumor type, we believe a single CER construct may demonstrate clinical utility in treating an array of cancers. To that end, we have focused our development activities on optimizing the cancer killing capabilities of a specific CER-T therapeutic design. These efforts have resulted in our lead clinical candidate, CER-1236. 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. |

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