Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1482 |
| INN | Veligrotug |
| Status | Clinical |
| Drug code(s) | ZB001, VRDN-001, IMGN164, AVE1642 |
| Brand name | None |
| 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) | IGF-1R |
| Indications of clinical studies | Thyroid eye disease, breast cancer, liver cancer, multiple myeloma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2006 |
| Start of Phase 2 | October 15, 2008 |
| Start of Phase 3 | December 15, 2022 |
| 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 | Sanofi |
| Licensee/Partner | Zenas Biopharma, miRagen |
| Comments about company or candidate | Sep 2024: Viridian Therapeutics, Inc. is On-Track to Submit Biologics License Application (BLA) in Second Half of 2025 NCT06021054 Phase 3 in TED due to start in Sep 2023. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-VRDN-001-Phase-3-THRIVE-Clinical-Trial-in-Patients-with-Active-Thyroid-Eye-Disease/default.aspx. Phase 2/3 study for Thyroid Eye Disease (NCT05176639) is recruiting as of June 15, 2023. Dec 2022: Viridian Therapeutics, Inc. announced that the first patient has been enrolled in its THRIVE Phase 3 trial evaluating the efficacy and safety of the investigational agent VRDN-001 in patients with active thyroid eye disease (TED). The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe. NCT05542303 Phase 1 in healthy Chinese subjects due to start in Sep 2022. December 20, 2021 I Viridian Therapeutics, Inc. announced the first subject was dosed in a Phase 1/2 proof-of-concept clinical trial (NCT05176639) for VRDN-001, a monoclonal antibody that blocks the IGF-1 receptor with sub-nanomolar potency. October 14, 2021 I Viridian Therapeutics, Inc. announced today the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). The Company is seeking authorization to initiate a Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody in development for the treatment of thyroid eye disease. Oct. 28, 2020 -- miRagen Therapeutics, Inc. announced it has completed the acquisition of Viridian Therapeutics, Inc. (“Viridian”), a privately held biotechnology company focused on advancing new treatments for patients with diseases that are underserved by today’s therapies. The proceeds from a private placement are intended to be used primarily to advance clinical studies of VRDN-001, a clinical-stage insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody (mAb) in development for thyroid eye disease (TED), a debilitating condition that can cause bulging eyes, or proptosis, as well as double vision and potential blindness. miRagen’s lead candidate, VRDN-001 will be studied as a potential treatment for patients with TED. More than 100 oncology patients have previously been treated with the antibody in US and EU studies, under the name AVE-1642, enabling some understanding of its pharmacokinetic and pharmacodynamic profile, as well as its safety and tolerability. Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021. Worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED, were exclusively licensed by Viridian from ImmunoGen, Inc. Under the terms of the agreement, ImmunoGen received an upfront payment, and is eligible for additional developmental milestones and mid-single-digit royalty payments. Development terminated by Sanofi in 2010; Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns |
| Full address of company | Paris Europe France https://www.sanofi.us/en/contact-us |
Humanized IgG1kappa mAb targeting IGF-1R extracellular domain. Full agonist. Described as chimeric in Proposed INN: List 128.
| Anticipated events | 2025 BLA planned |
| Factor(s) contributing to discontinuation | None |