Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 142

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 142
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 the design of our CER-T constructs based upon many of the components found in existing conventional CAR-T cell therapies, which we believe could shorten development timelines and enhance commercial application. The processes and protocols used to genetically modify a patient’s T cells to produce CAR-T cells are already well recognized, as is the use of lentivirus in the manufacture of these therapies. Accordingly, we have developed CER-T cell manufacturing processes that closely resemble those used to produce existing engineered CAR-T cells. We also expect to benefit from the well-defined and recognized regulatory guidelines established by both U.S. and European regulatory authorities related to CAR-T therapies and their use. In contrast to these attributes, we believe that other emerging CAR-based drug candidates which involve immune effector cells other than T cells, such as CAR-NK and CAR-M therapies, are unlikely to enjoy similar benefits. 84 In preclinical studies, we have observed CER-1236 to display attractive functional attributes, among which are:

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

| ● | phagocytosis    
 of tumor cells; |

| ● | 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. |

Based on the preclinical data regarding the use of CER-1236 T cells to combat hematologic malignancies, we anticipate beginning clinical trials in the first half of 2025. We anticipate that our initial targets will be relapsed, remitting acute myeloid leukemia (“AML”) patients as well as AML patients with measurable residual disease (“MRD”) and patients with mutations in TP53, a gene mutation associated with aggressive AML. AML is a heterogenous and aggressive hematopoietic malignancy characterized by the rapid buildup of immature myeloid cells in the bone marrow and blood. This process results in the inhibition of normal haematopoiesis, manifesting as neutropenia, an