Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1734 |
| INN | Odronextamab |
| Status | Approved |
| Drug code(s) | REGN1979 |
| Brand name | Ordspono |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (VelocImmune) |
| Target(s) | CD20, CD3 |
| Indications of clinical studies | Follicular Lymphoma, DLBCL, CD20+ B-cell malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2014 |
| Start of Phase 2 | July 24, 2019 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Odronextamab |
| US or EU approved indications | EU: Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | Zai Lab |
| Comments about company or candidate | On August 26, 2024, Regeneron announced that the European Commission approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. June 28, 2024: Regeneron Pharmaceuticals, Inc., announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. March 25, 2024: Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has issued Complete Response Letters for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. Aug. 17, 2023: Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL. May 2023: Regeneron to submit a Biologics License Application (BLA) to the FDA for relapsed/refractory (R/R) DLBCL and R/R FL in the second half of 2023. FDA grants Fast Track designation for R/R FL and DLBCL. In December 2022, Regeneron announced positive first interim data from the ELM-2 Phase II trial in patients with heavily pre-treated, R/R FL and DLBCL. Potentially registrational trial in NHL started by Zai Lab in Oct 2021. December 14, 2020 I Regeneron is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold. The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent. April 2020: Regeneron Pharmaceuticals and Zai Lab announced a strategic collaboration for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau. The collaboration will support global clinical development for REGN1979, starting with the ongoing potentially registrational Phase II program in B-cell non-Hodgkin lymphoma (B-NHL). Additionally, if REGN1979 is approved, Zai Lab will leverage its capabilities to commercialize REGN1979 in this region. Feb 2020: Regeneron plans regulatory submission in B cell NHL in 2020. Aug 6, 2019 press release: Phase 2 study in relapsed or refractory follicular lymphoma (FL) is recruiting patients. NCT03888105 Phase 2 study in Follicular Lymphoma started recruiting Jul 24 2019. In June 2019, the Company presented updated positive results from a study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma at the European Hematology Association meeting. May 2019: Regeneron Discloses Two Deaths from its Bispecific Antibody RGN1979, thought to be due to dosing (researchers discovered enhanced cytokine release syndrome that may be associated with increased tumor response. That increased toxicity was the possible cause of the two deaths). NCT02651662 and NCT02290951 Phase 1 studies recruiting as of Aug 2018. Jan 2018: The FDA designates Regeneron Pharmaceuticals' Phase 1-stage REGN1979 an Orphan Drug for the treatment of follicular lymphoma. NCT02290951 Phase 1 recruiting as of Nov 2014. US orphan designation for lymphoma, B-cell, diffuse large. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
common light chain, hetero-H-chain IgG; REGN1979 is a hinge-stabilized human bispecific antibody based on an IgG4 isotype modified to reduce Fc binding. REGN1979 described in Sci Rep. 2015; 5: 17943. Published online 2015 Dec 11. doi: 10.1038/srep17943
| Anticipated events | In review in US but CRL issued |
| Factor(s) contributing to discontinuation | None |