Company: LIMN
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001104659-25-010605
Chunk: 349

Company: Liminatus Pharma, Inc.
Filing Date: 2025-02-07
Form: 424B3
Chunk 349
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• Study design and standards • The 4-week toxicity study of IBA101 in Cynomolgus monkeys, conducted by Charles River Laboratories, was designed and analyzed according to GLP (Good Laboratory Practice) standards. This ensured the reliability and reproducibility of the data, adhering to 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