On August 16, 2021 Incyte (NASDAQ:INCY) and InnoCare (HKEX: 09969) reported that Incyte and a subsidiary of InnoCare have entered into a collaboration and license agreement for the development and commercialization of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in Greater China (Press release, Incyte, AUG 16, 2021, View Source [SID1234586639]).
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Under the terms of the agreement, InnoCare will pay Incyte US$35 million up front, and Incyte is eligible to receive up to an additional US$82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.
InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.
"The collaboration with InnoCare allows us to accelerate the expansion of our partnered portfolio in China," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We believe InnoCare will be an excellent partner to accelerate the development of tafasitamab, and if approved, help bring this innovative therapy to patients and healthcare providers in Greater China."
"We are honored and excited to partner with Incyte, and are committed to making tafasitamab, an FDA-approved treatment, available to eligible patients in Greater China, upon approval. The strategic collaboration with Incyte will not only enhance our strength in the field of hematology and oncology, but also offer us good opportunity to explore the potential clinical benefit of our BTK inhibitor orelabrutinib in combination with tafasitamab," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "In addition, we believe that tafasitamab, an innovative CD19 antibody, is critical to solidifying our long-term strategy to strengthen our large molecule capabilities and to enhance combinational therapies with our existing pipelines."
The transaction is effective immediately upon the execution of the collaboration and license agreement.
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 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 (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 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 is a registered trademark of MorphoSys AG.
XmAb is a registered trademark of Xencor, Inc.