Knight Therapeutics Announces Approval of Minjuvi® in Mexico

Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. has obtained regulatory approval by COFEPRIS, the Mexican health regulatory agency, for Minjuvi ® (tafasitamab) in combination with lenalidomide followed by Minjuvi ® monotherapy 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 outcomes ¹ .

The approval is 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% ³ . According to the 2024 National Comprehensive Cancer Network (NCCN) Guidelines, Minjuvi ^® is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation ² .

"Minjuvi ^® has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL. It is a chemo-free targeted immunotherapy which offers sustained remission for non-transplant eligible adult patients who have relapsed or are refractory to at least one previous line of treatment. I am enthusiastic about the transformative potential of Minjuvi ^® in improving patient outcomes," said Dr. Adrian Alejandro Ceballos, internist and hematologist at CENIT Medical Center in Merida, Mexico.

"We are thrilled to announce the approval of Minjuvi ^® , in Mexico, an innovative treatment for adult patients with relapsed or refractory DLBCL. With its novel mechanism of action, Minjuvi ^® offers a new treatment alternative to non-transplant eligible patients who have limited treatment options. This approval, with launch expected in the first half of 2025, marks an important step in our mission to bring life-changing therapies to the Mexican market and improve the lives of patients facing this challenging condition," 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.

About Minjuvi ^® (tafasitamab)

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

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, 2023, 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. 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
2. National Comprehensive Cancer Network (NCCN) Guidelines. B-Cell Lymphomas dated January 18, 2024. Accessible at: Treatment by Cancer Type ( nccn.org )
3. Duell, J et al. 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.2020.275958
   
   

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