On July 31, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) approved MorphoSys’ Monjuvi (tafasitamab-cxix), a CD19-directed cytolytic antibody indicated 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) (Press release, Xencor, JUL 31, 2020, View Source [SID1234562655]). The most common adverse reactions (≥ 20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. Xencor has earned a $25 million milestone payment from MorphoSys under the license agreement between the companies for Monjuvi in connection with the regulatory approval.
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Xencor licensed exclusive worldwide rights to develop and commercialize Monjuvi, product code MOR208 and previously XmAb5574, to MorphoSys in 2010. Monjuvi incorporates Xencor’s XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.
"We are incredibly proud of Xencor’s discovery and early development of Monjuvi, an anti-CD19 antibody we engineered with our Cytotoxic XmAb Fc domain. Data from the L-MIND study highlight Monjuvi’s potential as treatment for people living with relapsed or refractory DLBCL, an aggressive form of lymphoma with poor clinical outcomes," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Monjuvi follows Alexion’s Ultomiris (ravulizumab-cwvz) as the second product incorporating XmAb technology to receive a marketing approval. These partnerships expand the use of our XmAb technology and provide us with an important source of non-dilutive capital, used to advance and expand our broad internal portfolio of novel XmAb bispecific antibodies and cytokine drug candidates."
Xencor is eligible to receive royalties on worldwide net sales in the high-single to low-double digit percent range and additional development, regulatory and sales milestone payments. Monjuvi will be co-commercialized in the U.S. by MorphoSys and Incyte Corporation. The European Marketing Authorization Application (MAA) for tafasitamab, based on data from the L-MIND study and supported by the Re-MIND observational retrospective study, is currently under review by the European Medicines Agency (EMA).
About Cytotoxic XmAb Fc Technology
Xencor’s Cytotoxic XmAb Fc domain is designed to improve the immune system’s elimination of tumors and other pathologic cells by antibody-dependent cellular cytotoxicity. The Cytotoxic Fc domain is engineered to increase binding affinity to activating Fcγ receptors to enhance activation of natural killer (NK) cells, as well as other immune cells such as macrophages, which play a role in immunity by engulfing and digesting foreign material.