Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 83

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 83
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b                           |
| RSV mRNA vaccine(SP0256)           | RSV older adult                                                                                | Phase 2                                    |
| Acne mRNA vaccine(SP0268)          | Acne                                                                                           | Phase 1                                    |

(1) Awaiting submission acceptance in the US. a) Immunology & Inflammation a mlitelimab (SAR445229 ) , a human monoclonal antibody blocking OX40L pathway, is a ‘pipeline-in-a-product’ asset currently being assessed in clinical programs for the treatment of a range of immune diseases. In AD, the dosing of once every 12 weeks is being assessed in a large Phase 3 clinical program (OCEANA). Enrollment of the four main AD studies designed to evaluate on- and off-treatment efficacy and safety in adults and adolescents continued in 2024, with results supporting subsequent regulatory submission (expected in 2026). The proof-of concept Phase 2 study (TIDE-Asthma) assessing amlitelimab in moderate-to-severe asthma has a 60-week double- blind placebo-controlled period, in which patients are dosed once every four weeks during the initial 24 weeks and once every 12 weeks for the subsequent 36 weeks. Sanofi anticipates results for the full and completed 60-week treatment and follow-up period will be available in the first half of 2025. The Phase 2 study of amlitelimab in hidradenitis suppurativa (HS) recruited its last patient in 2024; results are expected in the first half of 2025. In 2024, additional Phase 2 studies assessing the efficacy and safety of subcutaneous injections of amlitelimab enrolled their first patients in adults with non-responsive celiac disease, severe alopecia areata and systemic sclerosis, respectively. frexalimab (SAR441344) is a second generation anti-CD40L monoclonal antibody that blocks the costimulatory CD40/CD40L pathway, which is important for the activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc.

| SANOFIFORM 20-F2024 | 35 |

| PART I                             |
| ITEM 4. Information on the Company |

Frexalimab is a ‘pipeline-in-a-product’ asset being evaluated in Phase