Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 86 |
| INN | Teclistamab |
| Status | Approved |
| Drug code(s) | JNJ-64007957 |
| Brand name | TECVAYLI |
| mAb sequence source | mAb chimeric/human |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG4 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic (OmniRat technology) and DuoBody technology |
| Target(s) | BCMA, CD3 |
| Indications of clinical studies | Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Australia, China, Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2017 |
| Start of Phase 2 | September 17, 2020 |
| Start of Phase 3 | October 15, 2021 |
| Date BLA/NDA submitted to FDA | December 28, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | October 25, 2022 |
| INN, US product name | Teclistamab, teclistamab-cqyv |
| US or EU approved indications | 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 monoclonal antibody. |
| Company | Janssen Research & Development |
| Licensee/Partner | Genmab |
| Comments about company or candidate | Submission of MAA announced Jan 31, 2022; approved on August 3 NCT05083169 Phase 3 due to start on Oct 15, 2021. June 2021: Teclistamab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of relapsed or refractory multiple myeloma. This mAb also received PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) earlier this year. November 2020: Teclistamab Received FDA Orphan Drug Designation for Treatment of Multiple Myeloma NCT04557098 Phase 2 study in multiple myeloma started in Sep 2020. May 18, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results reported for the first time from a Phase 1 first-in-human dose escalation study (NCT03145181) of teclistamab (JNJ-7957), an investigational bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors on T-cells in the treatment of patients with relapsed or refractory multiple myeloma. Initial results suggest a manageable safety profile across all teclistamab doses evaluated. Investigators reported that patients achieved deep responses which persisted, including some minimal residual disease (MRD)-negative complete responses (CR) at 10-6, with one durable beyond 12 months.1 The data will be featured during the American Society of Clinical Oncology (ASCO) Virtual Scientific Program as an oral presentation on Saturday, May 30 at 1:00 p.m. ET (Abstract #100). NCT04108195 Phase 1b in MM started in Feb 2020. Phase 1 NCT03145181 in MM patients started in May 2017 still recruiting as of Aug 2019; listed in Janssen pipeline dated July 16, 2019. IND filing by Janssen affiliate CAN Development LLC announced in March 2017 by Ligand Pharma Inc. |
| Full address of company | 1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us |
Humanized BCMA x CD3 DuoBody® Antibody. According to Ligand, JNJ64007957, a BCMAxCD3 bispecific antibody discovered in part with the OmniAb platform technology (anti-BCMA portion) https://d1io3yog0oux5.cloudfront.net/_6354969c685a902561a4cc1672ab8293/ligand/db/242/1761/pdf/2019+AD+Corporate+Presentation_vFINAL.pdf
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |