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Knight Therapeutics Announces Launch of Minjuvi® (tafasitamab) in Mexico

1. Knight launches Minjuvi in Mexico for DLBCL treatment. 2. Minjuvi shows 60% overall response rate in clinical trials. 3. Incyte holds exclusive distribution rights for Tafasitamab in Latin America. 4. Minjuvi is preferred second-line treatment according to NCCN guidelines. 5. Tafasitamab demonstrates long-lasting responses with manageable toxicity.

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Why Bullish?

The successful launch of Minjuvi could enhance sales for Incyte, similar to successful launches of other oncology products which historically have led to price increases. If Minjuvi gains traction in Latin America, it could provide significant revenue in a region with unmet medical needs.

How important is it?

The article directly relates to INCY through the mention of Tafasitamab, impacting their revenue and market position. Given the promising clinical data and regulatory support, the likelihood of positive price movement for INCY is high.

Why Long Term?

The product's approval and subsequent market penetration could take time, aligning with long-term strategies. Notably, products that launch successfully and gain acceptance often continue to show sales growth over several years.

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GUDMORXNCR
March 26, 2025 07:30 ET  | Source: Knight Therapeutics MONTREAL, March 26, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. Minjuvi® in combination with lenalidomide, followed by Minjuvi® monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cell transplantation (ASCT). DLBCL is the most common subtype of non-Hodgkin lymphoma, presenting an aggressive clinical profile. While a significant number of patients can be cured with standard front-line therapy, many will develop refractory disease or relapse following an initial response, and these individuals are often ineligible for ASCT. Such patients face a very poor prognosis, emphasizing the need for treatment options to improve their outcomes1. The marketing authorization approval was based on the data from L-MIND trial, an open label, multicenter, single arm Phase 2 study, that evaluated Minjuvi® in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL ineligible for ASCT. The study primary analysis results demonstrated an objective response rate (ORR, primary endpoint) of 60%, including a complete response rate (CR) of 43% and a disease control rate (DCR) of 74%2. According to the 2025 National Comprehensive Cancer Network (NCCN) Guidelines, Minjuvi® is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation3. “The treatment of DLBCL has significantly evolved in recent years, particularly in the relapse/refractory setting. I am glad to have more tools for our patients, as half of those who relapse after first-line therapy are not candidates for autologous transplantation. For these patients, there are new and effective options including Minjuvi®, achieving high rates of long-lasting responses. Approximately 57% of responding patients were still in remission at 5 years and, as a chemo-free regimen, the toxicity is low-grade and manageable”, said Dr. Luis Mario Villela, head of the clinical hematology and blood bank of CMDRICH Hospital and head of the Lymphoma and Myeloma of Ocaranza ISSSTE Hospital in Hermosillo, Sonora, Mexico. Dr. Villela is also a member of the National Investigators System level II and member of GELL group. “Minjuvi® is an innovative product presenting clinically meaningful data in DLBCL and with exciting data in other rare lymphomas. We are thrilled to launch in another country and look forward to launching this product in additional markets in Latin America.” said Samira Sakhia, President and CEO of Knight. In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in Europe) in Latin America. In October 2024, COFEPRIS, the Mexican health regulatory agency, granted regulatory approval through orphan medicine recognition for Minjuvi® in Mexico. About Tafasitamab (Minjuvi®) Minjuvi® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the United States, Monjuvi® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi® monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or 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 TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca. Forward-Looking Statements for Knight Therapeutics Inc. 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, 2024, 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: Duarte C, Kamdar M. Management Considerations for Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma. Am Soc Clin Oncol Educ Book. 2023 Jan;43:e390802.Duell, J et al. (2021). Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958National Comprehensive Cancer Network (NCCN) Guidelines. B-Cell Lymphomas dated February, 10, 2025. Accessible at: Treatment by Cancer Type (nccn.org) CONTACT INFORMATION:   Knight Therapeutics Inc.   Samira SakhiaArvind UtchanahPresident & Chief Executive OfficerChief Financial OfficerT: 514.484.4483T. +598.2626.2344F: 514.481.4116 Email: IR@knighttx.comEmail: IR@knighttx.comWebsite: www.knighttx.comWebsite: www.knighttx.com

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