Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 96

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 96
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 all CTCLs (Dobos, 2020, Bradford, 2009). Sézary syndrome, characterized by the presence of lymphoma cells in the blood, is a CTCL subtype with a particularly poor prognosis. The following table outlines the most common CTCL types, their frequency as a percentage of all cases of CTCL (Dobos, 2020), and the prognosis (WHO-EORTC classification 2018 : Willemze, 2019).

  CTCL Type                                                                     Frequency among CTCL (%) Worldwide      5-year disease-specific survival (%)  
 ──────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
  Mycosis fungoides                                                                                             62      88                                    
  Primary cutaneous CD30 + lympho-proliferative disorders                                                       16      95-99                                 
  Primary cutaneous CD4 + small/medium T-cell lymphoproliferative disorder                                       2      100                                   
  Mycosis fungoides variants                                                                                     6      75-100                                
  Sézary syndrome                                                                                                3      36                                    

Patients with advanced CTCL have a poor prognosis with few therapeutic options and no standard of care. Treatment generally includes skin-directed therapies, such as topical corticosteroids, and systemic treatments, such as steroid drugs and interferon, for patients with more advanced disease or for whom skin-directed therapies failed. There are several approved agents for the treatment of CTCL:

• Bexarotene, approved by FDA in 1999, for use in patients with advanced stage of MF who are refractory to at least one prior systemic therapy;

• Vorinostat, approved by FDA in 2006 for for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+). However, ONTAK was voluntarily withdrawn from the U. S. market in 2014. In 2024, "LYMPHIR," also known as "E7777" or "I/ONTAK," a purified and more bioactive formulation of the previously FDA-approved ONTAK®, was approved for the treatment of adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) in stages I-III, after at least one prior systemic therapy.

• Denileukin diftitox (DD