Knight Therapeutics and Incyte Amend Supply and Distribution Agreement to Add Retifanlimab and Axatilimab in Latin America

MONTREAL, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX:GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has expanded its existing relationship and amended its agreement with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), for the exclusive rights to distribute retifanlimab (sold as ZYNYZ® in the United States and Europe) and axatilimab (sold as NIKTIMVO™ in the United States) in Latin America.

Under the terms of the amended agreement Incyte will be responsible for the development, manufacture and supply to Knight of retifanlimab and axatilimab, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America. Knight and Incyte had entered into an exclusive supply and distribution agreement for MINVUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) in Latin America in September 2021.

Retifanlimab is approved in the United States and Europe for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.¹ Based on epidemiological data from two Brazilian registries, there are an estimated 550 – 1,250 new cases of MCC each year across Brazil, Mexico, Colombia and Argentina.² Retifanlimab is also approved by the U.S. Food and Drug Administration (FDA) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).¹ In addition, the FDA approved retifanlimab as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.¹ While epidemiological data for SCAC in LATAM is limited, there are approximately 2,700 – 4,000 new cases of SCAC each year in Brazil, Mexico, Colombia and Argentina.³

Axatilimab received FDA approval in August 2024 for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.⁴ Chronic GVHD is a serious complication of allogeneic stem cell transplantation in which the donor's immune cells attack the recipient's tissues, potentially affecting multiple organs such as the skin, liver, lungs, and gastrointestinal tract. There are approximately 1400 – 1800 reported allogeneic transplants in Brazil every year.⁵

"We are thrilled to expand our partnership with Incyte and for the opportunity to bring two innovative biologic products to the LATAM region," said Samira Sakhia, President and CEO of Knight Therapeutics. "These therapies are highly complementary to our existing portfolio and will significantly strengthen our presence in oncology and hematology, reinforcing our commitment to delivering transformative treatments to patients across Latin America."

"As a partner, Knight, has an extensive track record of successful collaborations as well as strong distribution capabilities in Latin America," said Lee Heeson, Executive Vice President and Head of Incyte International. "We look forward to continuing to work together and to expanding our existing partnership for tafasitamab and pemigatinib to include retifanlimab and axatilimab so that eligible patients in the region can access our innovative medicines."

About Retifanlimab

ZYNYZ® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.¹

ZYNYZ® is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.¹

ZYNYZ® is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

ZYNYZ® is a registered trademark of Incyte.

About Axatilimab

NIKTIMVO™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg .⁴

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in cGVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD; a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids which are expected to initiate by year end. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

NIKTIMVO™ is a trademark of Incyte. All other trademarks are the property of their respective owners.

References

1. Incyte Corporation. ZYNYZ (retifanlimab-dlwr) injection, for intravenous use: Full prescribing information. Retrieved July 24, 2025, from https://www.zynyz.com/zynyz-prescribing-information.
2. Melo, Andreia C de, and Luiz C Santos Thuler. "Trends in the Incidence and Morbidity of Merkel Cell Carcinoma in Brazil." Future Oncology 17, no. 22 (May 7, 2021): 2857–65. https://doi.org/10.2217/fon-2020-1313.
3. Mignozzi, Silvia, Claudia Santucci, Matteo Malvezzi, Fabio Levi, Carlo La Vecchia, and Eva Negri. "Global Trends in Anal Cancer Incidence and Mortality." European Journal of Cancer Prevention 33, no. 2 (November 27, 2023): 77–86. https://doi.org/10.1097/cej.0000000000000842.
4. Incyte Corporation. NIKTIMVO (axatilimab-csfr) injection, for intravenous use: Full prescribing information. Retrieved July 24, 2025, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761411s000lbl.pdf.
5. Associação Brasileira De Transplante De Órgãos. "Registro Brasileiro de Transplantes."XXV No. 3. https://site.abto.org.br/wp-content/uploads/2024/11/RBT2024-3t-abto-populacao.pdf
   
   
   
   

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

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.