On August 17, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that Incyte, its development and commercialization partner for tafasitamab, entered into a collaboration and license agreement with a subsidiary of InnoCare for tafasitamab in Greater China (Press release, MorphoSys, AUG 17, 2021, View Source [SID1234586675]). Under the terms of the agreement, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in hematology-oncology in mainland China, Hong Kong, Macau and Taiwan.
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In January 2020, MorphoSys and Incyte entered into a collaboration and license agreement to develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab globally. MorphoSys and Incyte co-commercialize tafasitamab in the U.S., and Incyte holds the development and commercialization rights for tafasitamab outside the U.S. MorphoSys will receive tiered royalties on ex-U.S. net sales.
About Tafasitamab
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(R) 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).
Monjuvi(R) (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 diffuse large B-cell lymphoma (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).
In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.
In June 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab 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). The CHMP opinion is currently being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.