Company: LIMN
Filing Date: 2025-01-27
Form Type: POS AM
Source: 0001104659-25-006325
Chunk: 352

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-27
Form: POS AM
Chunk 352
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 rigorous quality standards throughout the study. • Parameters and endpoints of evaluation Based on the most recent body weight measurement, the following parameters and endpoints were evaluated:

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TABLE OF CONTENTS

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

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

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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:

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

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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:

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

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

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

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

#### Efficacy-related studies
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CD47 antibody blocks interaction of CD47 and SIRPα

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

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

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In vitro phagocytosis assay demonstrated that human macrophages promoted the uptake