Knight Therapeutics has signed an exclusive distribution agreement with Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin, to distribute mogamulizumab in selected Latin American countries.

Under the agreement, Knight will be responsible for obtaining regulatory approvals and commercialising mogamulizumab in Brazil, Mexico, Colombia and Argentina. The medicine is marketed as Poteligeo in the United States and Europe.

Mogamulizumab is a humanised monoclonal antibody that targets chemokine receptor 4 (CCR4), a receptor expressed on malignant T cells. Poteligeo is approved in the US and Europe for the treatment of adult patients with relapsed or refractory Mycosis Fungoides (MF) or Sézary Syndrome (SS) following at least one prior systemic therapy.

MF and SS are the two most common subtypes of Cutaneous T-Cell Lymphoma (CTCL), a rare form of non-Hodgkin lymphoma that can affect the skin, blood, lymph nodes and internal organs. CTCL can cause persistent and painful skin lesions, with symptoms that may make diagnosis challenging.

The companies noted that epidemiological data on CTCL in Latin America remains limited. In the US, reported annual incidences are 5.42 cases per million for MF and 0.21 cases per million for SS. Together, the two conditions account for approximately 65 percent of CTCL cases.

The clinical development of mogamulizumab included the Phase 3 MAVORIC study, which evaluated the therapy against vorinostat in patients with MF or SS who had received at least one prior systemic treatment. The trial enrolled 372 patients and reported median progression-free survival of 7.7 months with mogamulizumab compared with 3.1 months with vorinostat.

The confirmed overall response rate was 28 percent with mogamulizumab and 5 percent with vorinostat. Reported adverse effects included rash, infusion-related reactions, upper respiratory tract infections, musculoskeletal pain, fever and mucositis.

Samira Sakhia, President and CEO of Knight Therapeutics, said the agreement expands the company's hemato-oncology portfolio and is intended to increase access to treatment for patients with MF and SS in its key Latin American markets.