Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY SUPPLEMENTAL SUBMISSION OF MINJUVI(TM) (TAFASITAMAB) FOR FOLLICULAR LYMPHOMA IN BRAZIL

Knight Therapeutics Inc.'s Brazilian affiliate, United Medical Ltda., has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL). The supplemental application for the additional indication was selected for review under Project Orbis.

In September, 2021, Knight entered into an exclusive supply and distribution agreement with Incyte, for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi outside of the U.S.), as well as Pemazyre (pemigatinib), in Latin America.

In February, 2024, Knight announced the launch of Minjuvi in Brazil 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).

"This regulatory submission for a new indication for tafasitamab in relapsed or refractory FL highlights our steadfast commitment to bringing innovation and enhancing quality of life and care," said Samira Sakhia, president and chief executive officer of Knight Therapeutics. "If approved, the combination of tafasitamab, rituximab and lenalidomide will be an important new therapeutic option for eligible adult patients with previously treated FL in Brazil. We look forward to continuing to work towards regulatory submissions in additional countries in Latin America over the next months."

About Follicular Lymphoma (FL) and inMIND Study

FL is the most common indolent, or slow growing, form of non-Hodgkin lymphoma (NHL). In Brazil, according to the 2023 data from the National Cancer Institute (INCA) registries, the expected incidence per year of NHL (inclusive of all subtypes) was 5.57 per 100,000 in the general population, 6.42 per 100,000 in the male population and 5.62 per 100,000 in the female population. It is expected that follicular lymphoma constitutes 20 per cent to 25 per cent of adult NHL cases. There are limited treatment options for relapsed or refractory FL.

The submission is based on the results from the pivotal phase 3 inMIND trial, a double-blind, placebo-controlled trial randomizing 548 patients with relapsed or refractory FL to receive tafasitamab or placebo with lenalidomide and rituximab. Key results from the trial demonstrated that tafasitamab plus lenalidomide and rituximab significantly improved progression-free survival (PFS) in patients with relapsed or refractory FL compared with a placebo. The median PFS was 22.4 months in the treatment arm, versus 13.9 months in the placebo arm, representing a 57-per-cent reduction in the risk of disease progression, relapse or death. Secondary endpoints also showed improvements, with higher response rates and longer durations of response observed in the treatment arm.

About Minjuvi (tafasitamab)

Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. 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). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma.

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. 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.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos, and the triangle design are registered trademarks of Incyte.

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 the Toronto Stock Exchange under the symbol GUD.

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