Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES LAUNCH OF MINJUVI(TM) IN BRAZIL

Knight Therapeutics Inc.'s Brazilian affiliate, United Medical Ltda., has launched Minjuvi. Minjuvi is indicated in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

DLBCL, the most common subtype of non-Hodgkin lymphoma, presents an aggressive clinical profile. Although a significant number of patients can be cured with standard front-line therapy, many will exhibit refractory disease or relapse following an initial response and are ineligible to transplant. These patients face a very poor prognosis and need novel treatment option to improve their outcomes.

According to National Comprehensive Cancer Network guidelines, Minjuvi is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation. The marketing authorization was based on the data from L-MIND study, an open-label, multicentre, single-arm phase 2 trial. The primary end point results showed an objective response rate (ORR) of 60 per cent, which includes a complete response rate (CR) of 43 per cent and a disease control rate (DCR) of 75 per cent.

"The launch of Minjuvi brings a new treatment option to relapsed or refractory non-transplant eligible DLBCL adult patients due to its innovative characteristics and proven efficacy, with a reasonable safety profile," said Dr. Guilherme Perini, hematologist specialized in lymphomas at Hospital Israelita Albert Einstein. "Minjuvi will improve patients' standard of care and it is a highly anticipated therapy for our patients," added Dr. Perini.

In September, 2021, Knight entered into a supply and distribution agreement with Incyte, for the exclusive rights to distribute pemigatinib (Pemazyre) as well as tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) in Latin America. In July, 2023, ANVISA (Agencia Nacional de Vigilancia Sanitaria) granted market authorization for Minjuvi under the rare disease designation according to Resolution RDC 205/2017. Additionally, in October, 2023, Knight received pricing approval for Minjuvi from the Drugs Market Regulation Chamber (CMED).

"In line with Knight's commitment to advancing health care in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need," said Samira Sakhia, Knight Therapeutics president and chief executive officer.

"Knight's team in Brazil is thrilled to make Minjuvi available to health care professionals and centres, improving DLBCL patient care in the country," said Cristiane Coelho, Knight Therapeutics Brazil general manager.

About tafasitamab (Minjuvi)

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor Inc. In 2024, Incyte was assigned such licence and now exclusively holds such rights. 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).

In the United States, Monjuvi (tafasitamab-cxix) is approved 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 autologous stem cell transplantation (ASCT). This indication has received accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in confirmatory trial(s). Please see the U.S. full prescribing information for Monjuvi for important safety information.

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization, 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).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several continuing combination trials. Its safety and efficacy for these investigational indications have not been established in pivotal trials.

About Knight Therapeutics Inc.

Knight Therapeutics, 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' shares trade on Toronto Stock Exchange under the symbol GUD.

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