Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 144

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 144
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 weight measurement, the following parameters and endpoints were evaluated:

| ● | Mortality, clinical signs, body weight, ophthalmology, electrocardiographic examinations |

| ● | Clinical pathology parameters (hematology, coagulation, clinical chemistry, and urinalysis) |

| ● | Anti-drug antibody analysis, toxicokinetic parameters, organ weights, and macroscopic and microscopic examinations. |

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| ● | Conclusion:   Toxicokinetic Analysis |

Following once-weekly (Days 1, 8, 15, 22, and 29) intravenous dosing of IBA101 to Cynomolgus monkeys at 0, 10, 30, or 100 mg/kg/dose:

| ● | No significant IBA101-related effects were noted at any dose level, indicating that 100 mg/kg/dose was well-tolerated. |

| ● | All study parameters, including body weight, clinical pathology results, and toxicokinetic measurements, were analyzed for statistical significance using standard statistical methods. At the highest dose tested (100 mg/kg), no statistically significant differences were observed in any parameter compared to the vehicle control group, supporting the determination of the No Observed Adverse Effect Level (NOAEL) at 100 mg/kg/ dose. Anti-drug antibody analysis, toxicokinetic parameters, organ weights, and macroscopic and microscopic examinations. |

On Day 22, the combined sex mean C0, Cmax, and AUC0-168hr values of IBA101 at the NOAEL were:

| ● | No C0 (Initial Plasma Concentration): 4,310,000 ng/mL |

| ● | Cmax (Maximum Plasma Concentration): 4,080,000 ng/mL |

| ● | AUC0-168hr (Area Under the Concetration-Time Curve): 359,000,000 hr*ng/mL. |

| ● | These toxicokinetic results suggest a good safety profile of IBA101 under the tested conditions and provide statistical evidence for its tolerability. |

Efficacy-related studies

| ● | CD47 antibody blocks interaction of CD47 and SIRPα |

| ● | A competitive ELISA assay demonstrated that the interaction between recombinant CD47 and recombinant SIRPα proteins was blocked by Hu3A5 in vitro. |

| ● | CD47 antibody promotes phagocytosis of live tumor cells by human macrophages. |

| ● | In vitro phagoc