On February 5, 2024 Incyte (Nasdaq:INCY) reported that it has entered into an asset purchase agreement with MorphoSys AG (FSE: MOR; NASDAQ: MOR) which gives Incyte exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi (tafasitamab-cxix) and outside of the U.S. as Minjuvi (tafasitamab) (Press release, Incyte, FEB 5, 2024, View Source [SID1234639852]).

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"This new agreement with MorphoSys provides Incyte with exclusive global rights to tafasitamab and full control over its development and commercialization, allowing us to realize significant operating efficiencies and cost synergies," said Hervé Hoppenot, Chief Executive Officer, Incyte.

In the previous agreement, MorphoSys and Incyte were collaborating and sharing costs for the clinical development and commercialization of tafasitamab in the U.S.; Incyte had exclusive rights outside of the U.S. Under the terms of the new agreement, MorphoSys will receive a payment of $25 million from Incyte and Incyte will gain global development and commercialization rights for tafasitamab. Incyte will now recognize revenue and cost for all U.S. commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. The agreement is effective immediately.

In addition to its approved indication, tafasitamab is being evaluated as a therapeutic option in ongoing pivotal trials for first-line DLBCL, relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL).

About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19-targeting immunotherapy. 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).

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 transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a 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 transplant (ASCT).

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

Monjuvi and Minjuvi are registered trademarks of Incyte. Tafasitamab is marketed by under the brand name Monjuvi in the U.S., and under the brand name Minjuvi in the EU and Canada.

XmAb is a registered trademark of Xencor, Inc.