News Details

MONTREAL, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the signing of an exclusive distribution agreement with Kyowa Kirin International (“KKI”), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151) (“Kyowa Kirin”), a Japan-based global specialty pharmaceutical company, for mogamulizumab (sold as POTELIGEO® in the United States and Europe) across certain Latin American countries. Under the terms of this agreement Knight will be responsible for obtaining regulatory approval and commercializing mogamulizumab in Brazil, Mexico, Colombia and Argentina.

Mogamulizumab is a humanized monoclonal antibody (mAb) targeting chemokine receptor 4 (CCR4), a receptor expressed on malignant T cells. POTELIGEO® is approved in the United States and Europe for treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS), after at least one prior systemic therapy, the two most common subtypes of cutaneous T-cell lymphoma (CTCL).^1,2,3

CTCL is a rare form of non-Hodgkin lymphoma that can affect the skin, blood, lymph nodes and internal organs.^4,5 CTCL often presents with persistent, inflamed skin lesions that can resemble benign dermatologic conditions, leading to delayed diagnosis and treatment. Patients frequently endure painful, itchy, and disfiguring skin symptoms that fluctuate unpredictably, contributing to physical discomfort, emotional distress, and can lead to a reduced life expectancy.⁶ Epidemiological data for CTCL in Latin America is limited, but is believed to be in line with the United States where the reported annual incidences of MF and SS are 5.42 per million and 0.21 per million, respectively.⁷ Together MF and SS represent approximately 65% of all cases of CTCL.⁵

“We are thrilled to add Kyowa Kirin, a Japan-based global specialty pharmaceutical company, as a new Knight partner. POTELIGEO® represents an innovative advancement in the treatment of rare cancers, specifically mycosis fungoides and Sézary syndrome. Its addition to our hemato-oncology portfolio addresses a significant unmet medical need and will provide patients across our key Latin American markets with access to a much-needed new therapeutic option,” said Samira Sakhia, President and CEO of Knight Therapeutics Inc.

Céline Rhême, Cluster General Manager, Emerging Growth Markets, Kyowa Kirin International, commented: “CTCL is more common in this region than many realise, and further work is needed to identify unmet needs and therefore drive improvements in patient outcomes.⁸ We have an opportunity, and a responsibility, to change that. Through our proud partnership with Knight Therapeutics, we can help to increase patient access in Latin America, as part of our ongoing and relentless commitment to bring life-changing value and make people smile.”

About Mogamulizumab

Mogamulizumab is a first-in-class humanized mAb directed against CCR4, a protein expressed on cancerous cells seen in both MF and SS.^9,10,11 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.¹²

The approval of POTELIGEO® (mogamulizumab) is supported by the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, which is the largest randomized trial in MF and SS and the first to compare systemic therapies using progression-free survival (PFS) as a primary endpoint. MAVORIC was a Phase 3 open-label, multi-center, randomized study of mogamulizumab versus vorinostat in patients with MF and SS who have failed at least one prior systemic treatment. The study randomized a total of 372 patients to mogamulizumab or vorinostat. The results showed that mogamulizumab demonstrated significantly superior PFS at a median of 7.7 months [95% CI: 5.7, 10.3] compared to 3.1 months with vorinostat [95% CI: 2.9, 4.1], [hazard ratio 0.53: 95% CI: 0.41, 0.69; p<0.001]. The confirmed overall response rate for mogamulizumab and vorinostat was 28% and 5%, respectively (risk ratio [RR] 23.1, 95% CI 12.8–33.1; p<0.001).¹³ The most common side effects associated with mogamulizumab vs vorinostat included rash (36% vs 22%), infusion related reactions (33% vs <1%), upper respiratory tract infections (22% vs 16%), musculoskeletal pain (22% vs 17%), fever (18% vs 6%), and mucositis (14% vs 6%), respectively.¹⁴

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on the TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's website at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements for Knight

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

1. Kyowa Kirin, Inc. Poteligeo (mogamulizumab-kpkc) injection, for intravenous use [prescribing information]. Bedminster, NJ; 2018. Accessed November 11, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf
2. European Medicines Agency. Poteligeo: EPAR – Product information. Accessed November 11, 2025. https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf
3. Martinez XU, Di Raimondo C, Abdulla FR, Zain J, Rosen ST, Querfeld C. Leukaemic variants of cutaneous T-cell lymphoma: Erythrodermic mycosis fungoides and Sézary syndrome. Best Pract Res Clin Haematol. 2019;32(3):239-252. doi:10.1016/j.beha.2019.06.004
4. Willemze R, Cerroni L, Kempf W, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. doi:10.1182/blood-2018-11-
5. Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110(6):1713-1722. doi:10.1182/blood-2007-03-
6. Haun PL, Scarisbrick JJ. Fast Facts: Cutaneous T-cell Lymphoma. Karger Medical and Scientific Publishers; 2019. Accessed November 11, 2025. https://books.google.ca/books?id=bdRwEQAAQBAJ
7. Cai ZR, Chen ML, Weinstock MA, Kim YH, Novoa RA, Linos E. Incidence Trends of Primary Cutaneous T-Cell Lymphoma in the US From 2000 to 2018: A SEER Population Data Analysis. JAMA Oncol. 2022;8(11):1690-1692. doi:10.1001/jamaoncol.2022.
8. Dobos G, Pohrt A, Ram-Wolff C, Lebbé C, Bouaziz JD, Battistella M, Bagot M, de Masson A. Epidemiology of Cutaneous T-Cell Lymphomas: A Systematic Review and Meta-Analysis of 16,953 Patients. Cancers (Basel). 2020 Oct 11;12(10):2921. doi: 10.3390/cancers12102921. PMID: 33050643; PMCID: PMC7600606.
9. Ferenczi K, Fuhlbrigge RC, Pinkus J, Pinkus GS, Kupper TS. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119(6):1405-1410. doi:10.1046/j.1523-1747.2002.19610.
10. Yoshie O, Fujisawa R, Nakayama T, et al. Frequent expression of CCR4 in adult T-cell leukemia and human T-cell leukemia virus type 1-transformed T cells. Blood. 2002;99(5):1505-1511. doi:10.1182/blood.v99.5.
11. Ishida T, Utsunomiya A, Iida S, et al. Clinical significance of CCR4 expression in adult T-cell leukemia/lymphoma: its close association with skin involvement and unfavorable outcome. Clin Cancer Res. 2003;9(10 Pt 1):3625-3634.
12. Duvic M, Evans M, Wang C. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171-174. doi:10.1177/
13. Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. doi:10.1016/S1470-2045(18)30379-6
14. Kyowa Kirin, Inc. POTELIGEO (mogamulizumab for injection) [product monograph]. Bedminster, NJ: Kyowa Kirin, Inc.; June 20, 2022. Accessed November 12, 2025. https://pdf.hres.ca/dpd_pm/00066376.PDF

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