Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 152

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 152
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 of a cell. However, cellular stresses cause the externalization of TIM-4-L to the cell surface. Exposure of TIM-4-L on the outer surface acts as an “eat-me” signal and marks abnormal, stressed and dying or dead cells for phagocytic clearance. A variety of tumors have been shown to have constitutively increased surface TIM-4-L as a result of altered plasma membrane regulation. Among hematologic tumors, loss-of-function mutations in the flippase chaperone transmembrane protein 30A (“TMEM30A”), have been identified in approximately 11% of patients with diffuse large B cell lymphoma (“DLBCL”), and this mutation was correlated with improved response to the standard therapeutic regimen suggesting the host’s immune elimination of TIM-4-L positive tumor cells enhances tumor clearance. 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-