Company: LIMN
Filing Date: 2025-01-27
Form Type: POS AM
Source: 0001104659-25-006325
Chunk: 351

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-27
Form: POS AM
Chunk 351
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 compared with that of rat IgG-treated mice. • Anti-human CD47 mAb induces no/minimal inflammation in organs. • C57BL/6-hCD47/hSIRPα mice were subcutaneously engrafted with MC38-hCD47 tumor cells and were repeatedly injected with Hu3A5-G4 mAb and/or anti-mPD-1 mAb. • Lung, liver and kidney from each group of mice were collected 4th injection of Abs. H&E staining of organs showed that there was minimal or no inflammation in those organs. A 4-week Toxicity Study in Cynomolgus Monkeys Followed by a 4-Week Recovery Period • Objective of monkey toxicity study • The objective of this study was to determine the potential toxicity of IBA101(Anti-CD47 mAb), a monoclonal antibody conjugated with IgG4 Fc, when administered as an intravenous bolus injection once weekly (Days 1, 8, 15, 22, and 29) to non-human primates and to evaluate the potential reversibility of any findings following a 4-Week recovery period. In addition, the toxicokinetic characteristics of IBA101(Anti-CD47 mAb) were determined. The study design was as follows:

| Group No. | ​           | ​ | Test Article    | ​ | ​ | Dose Level(mg/kg/dose) |               |     |   | ​ | ​ | Dose Volume(a)(mL/kg) |             |   |   | ​ | ​ | DoseConcentration(mg/mL) |               |    |   | ​ | ​ | Main Study |   |   |   |   |   |   |   |   |   | ​ | ​ | Recovery Study |   |   |   |   |   |   |   |   |   | ​ |
| ​         | No. ofMales |   |                 |   | ​ | ​                      | No. ofFemales |     |   |   | ​ | ​                     | No. ofMales |   |   |   | ​ | ​                        | No. ofFemales |    |   |   | ​ |            |   |   |   |   |   |   |   |   |   |   |   |                |   |   |   |   |   |   |   |   |   |   |
| 1