Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 160 |
| INN | Tafasitamab |
| Status | Approved |
| Drug code(s) | XMAB-5574, MOR208, ICP-B04 |
| Brand name | Monjuvi, Minjuvi |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1/2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD19 |
| Indications of clinical studies | Mantle cell lymphoma, Diffuse Large B-cell Lymphoma, CLL, ALL, NHL |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Australia, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 29, 2010 |
| Start of Phase 2 | April 15, 2013 |
| Start of Phase 3 | June 15, 2016 |
| Date BLA/NDA submitted to FDA | October 28, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | July 31, 2020 |
| INN, US product name | Tafasitamab, Tafasitamab-cxix |
| US or EU approved indications | Tafasitamab, in Combination with Lenalidomide, is indicated for the treatment of adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| Company | Xencor |
| Licensee/Partner | MorphoSys, Incyte, Innocare |
| Comments about company or candidate | Positive opinon from EMA announced in late June 2021; approved by EC in Aug 2021. March 2, 2020: MorphoSys AG announced today that the U.S. Food and Drug Administration (FDA) accepted filing of MorphoSys' Biologics License Application (BLA) and granted priority review for tafasitamab, the Company's investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. The FDA has informed MorphoSys that they are not currently planning to hold an advisory committee meeting to discuss the application. Rolling BLA started in Oct 28, 2019, completed in Dec 2019. ;https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000OtherR.pdf] NCT02763319 Phase 2/3 study in Diffuse Large B-cell Lymphoma started in July 2016 still recruiting as of Sep 2018. Three Phase 2 studies recruiting as of June 2014. Breakthrough therapy designation for DLBCL; Fast track designation and US/EU orphan designations. June 28, 2010 MorphoSys AG and US-based biopharmaceutical company Xencor, Inc., announced today the signing of a worldwide exclusive license and collaboration agreement for an antibody in Phase 1 clinical development. The agreement provides MorphoSys with an exclusive worldwide license to XmAb5574, a high potency monoclonal antibody developed by Xencor for the treatment of B-cell malignancies. As part of the agreement, the companies will collaborate on the Phase 1 trial in patients with chronic lymphocytic leukemia (CLL) in the U.S.A., for which Xencor will continue to carry the costs under its development plan. MorphoSys will be solely responsible for further clinical development. Xencor will receive an upfront payment of US$ 13 million (approx. € 10.5 million), and will be eligible to receive development, regulatory- and commercialization-related milestone payments and tiered royalties based on product sales. Further financial terms were not disclosed. Original IND submitted by Xencor on Jan 29, 2010 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000MultidisciplineR.pdf] |
| Full address of company | Pasadena, California, United States North America United States of America https://xencor.com/ |
Humanized anti-CD19 antibody with an engineered Fc domain; XmAb5574 contains a modified constant fragment (Fc)–domain with 2 amino acid substitutions S239D and I332E that enhances its cytotoxic potency by increased affinity for activatory Fcγ receptor IIIa on effector cells and diminished binding to FcγRIIb. immunoglobulin G1-G2-kappa, anti-[Homo sapiens CD19 (B lymphocyte surface antigen B4, Leu-12)], monoclonal antibody; gamma1-gamma2 heavy chain Variable region genes for mouse anti-CD19 antibody (clone 4G7; ref. 23) or anti-CD22 antibody (RFB4) were ligated into the expression vector pcDNA3.1Zeo (Invitrogen) comprising the human light chain κ and heavy chain constant regions to produce constructs for the corresponding chimeric antibodies. To generate XmAb5574, the Fv of 4G7 was humanized (24) and affinity-matured using library design automation (M.J. Bernett, G.L. Moore, S. Karki, I. Vostiar, J.O. Richards, E. Pong, E.A. Zhukovsky, and J.R. Desjarlais, manuscript in preparation.) and substitutions S239D/I332E were introduced into the human Fc domain using standard molecular biology techniques. (https://aacrjournals.org/cancerres/article/68/19/8049/541320/Potent-In-vitro-and-In-vivo-Activity-of-an-Fc).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |