Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1735 |
| INN | Linvoseltamab |
| Status | Regulatory review |
| Drug code(s) | REGN5458 |
| Brand name | (Pending) |
| 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 | VelociBi™ platform |
| Target(s) | BCMA, CD3 |
| Indications of clinical studies | Chronic Kidney Disease, Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 02, 2019 |
| Start of Phase 2 | August 15, 2022 |
| Start of Phase 3 | October 15, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | August 20, 2024 I Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. Feb. 02, 2024: Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. NCT05730036 Phase 3 started in Sep 2023. August 2023 presentation: Linvoseltamab (BCMAxCD3) – Updated pivotal Phase 2 data presented at ASCO 2023; Phase 3 study to initiate in 3Q23; received Fast-Track designation from FDA; BLA planned in 4Q23 (https://investor.regeneron.com/static-files/a73a7d9c-591d-43e4-905f-6851ac1ff04e). May 25, 2023 press release "Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma" https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-bcmaxcd3-data-pivotal-trial-demonstrates . "the LINKER-MM1 trial will form the basis of planned submissions to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) later this year" 2023 FDA submission expected (https://investor.regeneron.com/static-files/dbe7aad3-8aff-483f-9366-fa1678d7b738) NCT05730036 Phase 3 due to start in May 2023. June 6 2022: FDA grants orphan drug designation for multiple myeloma Listed as Phase 2 in Regeneron pipeline dated May 2021; https://investor.regeneron.com/static-files/e90481f9-321f-4a55-804e-1d6ce4557112. NCT03761108 Phase 1/2 study in MM started in Jan 2019. REGN5458 is a human bispecific antibody that binds to BCMA and CD3. In vitro, REGN5458 efficiently activates T cells and induces polyclonal T cell killing of myeloma cell lines with a range of BCMA cell-surface densities, and also induces cytotoxicity of primary human plasma cells. 2018 ASH annual meeting (Dec), abstract 1944 REGN5458, a Bispecific BCMAxCD3 T Cell Engaging Antibody, Demonstrates Robust In Vitro and In Vivo Anti-Tumor Efficacy in Multiple Myeloma Models, Comparable to That of BCMA CAR T Cell. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
REGN5458 is a human bispecific antibody that binds to BCMA and CD3. REGN5458 and REGN5459 were invented using Regeneron's next generation VelocImmune® "human antibody mouse" technology, together with its VelociBi™ platform. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences. Hetero H, cL. Hetero HH: WT x H435R-Y436F (limits binding to Protein A, purification); HL-pairing: cL; both chains: E233P, F234V, L235A, G236del (Fc-silencing)
| Anticipated events | Approval anticipated; CRL recd. Aug 21, 2024 |
| Factor(s) contributing to discontinuation | None |