3 August 2020 - - The US Food and Drug Administration 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, US-based biopharmaceutical company Xencor, Inc. (NASDAQ: XNCR) said.

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 USD 25m milestone payment from MorphoSys under the license agreement between the companies for Monjuvi in connection with the regulatory approval.

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.

Xencor is eligible to receive royalties on worldwide net sales in the high-single to low-double digit % range and additional development, regulatory and sales milestone payments.

Monjuvi will be co-commercialised in the US by MorphoSys and Incyte Corp.

The European Marketing Authorization Application 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.

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 cells, as well as other immune cells such as macrophages, which play a role in immunity by engulfing and digesting foreign material.

Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases.

Currently, 17 candidates engineered with Xencor's XmAb technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action.