Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 116 |
| INN | Teplizumab |
| Status | Approved |
| Drug code(s) | PRV-031, MGA031, hOKT3γ1(Ala-Ala) |
| Brand name | TZIELD |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD3 |
| Indications of clinical studies | Type 1 Diabetes Mellitus, Diabetes |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 1997 |
| Start of Phase 2 | May 15, 2002 |
| Start of Phase 3 | October 15, 2006 |
| Date BLA/NDA submitted to FDA | November 02, 2020 |
| Year of first approval (global) | 2022 |
| Date of first US approval | November 17, 2022 |
| INN, US product name | Teplizumab, teplizumab-mzwv |
| US or EU approved indications | Delay onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D |
| Company | Macrogenics |
| Licensee/Partner | PROVENTION BIO INC., Sanofi |
| Comments about company or candidate | April 27 2023. Sanofi announced today the completion of its acquisition of ProventionBio, Inc. Oct 2022: Provention Bio and Sanofi entered into a co-promotion agreement for teplizumab, a type 1 diabetes drug that they expect will gain FDA approval in November. July 6, 2021: Provention Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. FDA stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with drug product originating from drug substance manufactured for historic clinical trials had failed to show PK comparability. Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced that the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). The FDA also granted Provention's request for Priority Review and assigned a user fee goal date of July 2, 2021, under the Prescription Drug User-Fee Act (PDUFA). Rolling BLA started in April 2020 for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies. Oct. 24, 2019: Provention Bio, Inc. announced the European Medicines Agency (EMA) has granted PRV-031 (teplizumab) PRIority MEdicines (PRIME) designation for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. August 2019, the FDA granted Breakthrough Therapy Designation to PRV-031 for the prevention or delay of clinical T1D in individuals at risk of developing the disease. NCT03875729 Phase 3 study started recruiting on April 5, 2019. Provention plans to design a new Phase 3 study, the PROTECT (PROvention T1D trial Evaluating C-peptide with Teplizumab) study, building on our knowhow and the lessons learned for previous teplizumab clinical trials. They believe the PROTECT study will have a relatively high probability of success, based on its C-peptide-based primary endpoint (designed to measure the preservation of beta cell mass) in conjunction with the evaluation of supportive parameters such as insulin use and HbA1c levels. They believe this single additional Phase 3 study may facilitate regulatory approval of PRV-031 in the U.S. and Europe. Study start is planned for late 2019. NCT01030861 Phase 2 study for delaying or preventing diabetes recruiting as of Feb 2017; non-commercial sponsor. Listed as P2 in Macrogenics pipeline as of Feb 2017. Previously licensed by Lilly but license was terminated in 2010. |
| Full address of company | Rockville, Maryland, United States North America United States of America https://macrogenics.com/ |
Humanized Orthoclone with 2 aa mutations in Fc (L234A, L235A). Teplizumab, also called MGA031 and hOKT31(Ala-Ala), is a humanized, non-Fc receptor binding, anti-CD3 monoclonal antibody. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |