Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 173

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 173
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 2 levels both in the absence and presence of ibrutinib. High levels of CER-1236 T cells did not persist in the periphery and animals that received CER-1236 T cells showed a greater than 95% contraction in cell count from peak numbers by Day 14 with subsequent CER-T cell expansion likely prompted by residual tumor cell encounters. CER-1236 T cells also maintained robust proliferative capacity despite repeated in vitro antigen challenges with no evidence of T cell exhaustion noted. These findings are illustrated in the following charts. A single infusion of CER-1236 T cells generated rapid cell expansion across repeated challenges CER-1236 demonstrates in vivo tumor clearance in NSCLC adenocarcinoma xenograft We envisioned that the simultaneous exposure to both osimertinib and CER-1236 would lead to synergistic in vivo anti-tumor responses. HCC827 NSCLC cells were inoculated into the flanks of NSG mice. Once established, the mice were dosed with a short course of the EGFR inhibitor osimertinib to prime TIM-4-L antigen on tumors and administered 2.5e6 CER-1236 T cells. Treatment groups that received the EGFR inhibitor alone, after initial tumor regression, developed progressive disease, as evidenced in the below left graph. In contrast, animals infused with CER-1236 T cells demonstrated potent anti-tumor responses in the presence of osimertinib. CER-1236 T cells expanded rapidly in the blood, with the highest expansion observed in the osimertinib-treated cohorts, as observed in the below right graph. Importantly, no evidence of organ toxicity or weight loss was observed with increases in body weight recorded in all groups over the course of the study. Analysis of the tumors post-infusion indicated extensive infiltration of T cells compared to untransduced controls. 102 CER-1236 T cells infused to Osimertinib dosed animals showed tumor elimination and higher levels of T cell expansion CER-1236 T cells infused to AML engrafted animals shows tumor elimination and T cell expansion We engrafted NSG-MHC double knock out mice with Kasumi-1, a TP53 mutant AML cell line. Once established, the mice were infused with a single dose of CER-1236 or control T cells. Animals infused with CER-1236 T cells showed rapid tumor elimination and long term control