Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 87 |
| INN | Talquetamab |
| Status | Approved |
| Drug code(s) | JNJ-64407564 |
| Brand name | Talvey |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | DuoBody platform |
| Target(s) | GPRC5D, CD3 |
| Indications of clinical studies | Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Switzerland, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 25, 2017 |
| Start of Phase 2 | January 08, 2021 |
| Start of Phase 3 | October 13, 2022 |
| Date BLA/NDA submitted to FDA | December 09, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | August 09, 2023 |
| INN, US product name | Talquetamab, talquetamab-tgvs |
| US or EU approved indications | Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. |
| Company | Janssen Research & Development |
| Licensee/Partner | Genmab |
| Comments about company or candidate | Aug. 9, 2023: U.S. Food and Drug Administration has granted accelerated approval of TALVEY™ (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. CHPM provided positive opinion July 20 2023. December 9, 2022 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and separately targets CD3 on T cells. BLA included Phase 1 and pivotal Phase 2 data only. NCT05461209 Phase 3 due to start in Nov 2022 withdrawn due to a business decision. NCT05455320 and NCT05552222 Phase 3 studies started in Oct 2022. June 2022: U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. This distinction for talquetamab follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) on January 29, 2021, and an Orphan Drug Designation (ODD) from the FDA on May 3, 2021. Also Orphan Drug designation in the EU. NCT04634552 pivotal Phase 2 in MM started in Jan 2021. NCT04586426 Phase 1 in MM not yet recruiting when posted on Oct 14, 2020. NCT04108195 Phase 1 started in Feb 2020. NCT03399799 Phase 1 study in adult participants with relapsed or refractory multiple myeloma started in Dec 2017 still recruiting as of Aug 2019; listed in Janssen pipeline dated July 16, 2019. IND 133811 submitted to FDA on 25 September 2017 to support the investigation of talquetamab in the treatment of subjects with relapsed or refractory multiple myeloma. The notification that the study was safe to proceed was provided on 25 October 2017. |
| Full address of company | 1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us |
Talquetamab has PAA mutations in the Fc region and demonstrated no binding to FcγRI and less binding to FcγRIIa relative to an unmodified IgG4 mAb. The binding of talquetamab to FcγRIIIa was similar to the binding observed for an unmodified IgG4 mAb. The binding of talquetamab to FcRn was assessed in an enzyme-catalyzed luminescence competition assay. Talquetamab bound FcRn similarly as unmodified IgG1 and IgG4 mAbs. [Hinge-stabilization (S228P), Reduce Fc effector function (F234A-L235A)] (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761342Orig1s000MultidisciplineR.pdf) JNJ-64407564 is a Humanized DuoBody® Antibody. GPRC5D is highly expressed in multiple myeloma cells. IG4-kappa/G4-lambda, anti-[Homo sapiens GPRC5D (G protein-coupled receptor class C group 5 member D)], and anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)], humanized and chimeric monoclonal antibody, bispecific.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |