Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1784 |
| INN | Adintrevimab |
| Status | Terminated |
| Drug code(s) | ADG20 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cells (Convalescent source) |
| Target(s) | SARS-CoV-2 (spike protein) |
| Indications of clinical studies | COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | March 22, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | April 23, 2021 |
| 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 | Invivyd |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 2022: all the phase studies (NCT04859517, NCT04805671) were terminated (All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.) Name change to Invivyd (formerly Adagio Therapeutics, Inc.) Sep 2022: Company appears to be transitioning to a new candidate, NVD200 is a combination of two monoclonal antibodies which demonstrated potent in vitro neutralizing activity against prior and current SARS-CoV-2 variants of concern, including Omicron BA.1, BA.2, BA.4, BA.5, and BA.2.75 sublineages, as well as the more antigenically divergent SARS-CoV-1. This antibody combination has been selected for neutralization potency, breadth of coverage, and non-dominant epitope recognition. The antibodies in the combination target non-overlapping epitopes that are rarely targeted by endogenous neutralizing antibodies, which limits immune pressure on these sites and increases the probability of sustained utility in an evolving viral landscape. One of the antibodies in the combination is a re-engineered version of adintrevimab, the company’s most advanced product candidate, which met all primary endpoints with statistical significance in a pre-Omicron setting in global Phase 3 clinical trials for the prevention and treatment of COVID-19. April 2022: Based on feedback from the FDA regarding adintrevimab’s lack of neutralizing activity against the BA.2 variant, Adagio is pausing the submission of an EUA request. NCT04805671 Phase 1/2/3 for treatment of mild to moderate COVID-19 started in March 2021; NCT04859517 Phase 2/3 for prevention of COVID-19 started in April 2021. Nov 2020: Adagio Therapeutics has raised $80m in funding to further advance best-in-class antibodies to both treat and protect against Covid-19. The company plans to use the proceeds to advance its lead antibody candidate, ADG20, into clinical development early next year for the treatment of the disease. Precursor to AD20 described in An Engineered Antibody with Broad Protective Efficacy in Murine Models of SARS and COVID-19 (https://www.biorxiv.org/content/10.1101/2020.11.17.385500v1.full.pdf). Derived from memory B cells of a 2003 SARS survivor that cross-neutralize multiple SARS-related viruses; affinity matured using yeast display. Adagio is a spin out of Adimab, LLC. Adagio is developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV-1, and additional potentially emergent coronaviruses. We believe our antibodies will match or exceed the potency and coverage of conventional SARS-CoV-2 antibody programs and can be used as both therapeutic and durable prophylactic treatments. Our candidates are engineered using best-in-industry antibody discovery capabilities and are designed to maximize potency and duration of effect. Our portfolio includes multiple, non-competing antibodies with distinct binding targets, enabling a strategy that can avoid viral escape. Our lead program is expected to enter the clinic by the end of 2020. Adagio's broadly neutralizing monoclonal antibodies bind to a highly conserved epitope on the spike protein of multiple coronaviruses (SARS-CoV-2, SARS-CoV-1, and two circulating bat coronaviruses) thereby reducing the potential risk of viral escape. They have been additionally engineered to maximize potency, with the goal of offering significant therapeutic benefit, as well as protection for multiple months following a single dose injection. In conclusion, the potent cross-neutralizing antibodies described here bind to conserved epitopes overlapping the hACE2 binding site, thus illuminating this antigenic surface as a promising target for the rational design of pan-sarbecovirus vaccines. For example, the RBD epitope(s) defined by this class of antibodies could be presented on conformationally stable protein scaffolds to focus the antibody response on this site, as previously demonstrated for the motavizumab epitope on RSV F (19). Furthermore, the nAbs themselves, alone or in combination, represent promising candidates for prophylaxis or therapy of SARS, COVID-19, and potentially future diseases caused by new emerging SARS-like viruses. https://science.sciencemag.org/content/sci/early/2020/06/15/science.abc7424.full.pdf |
| Full address of company | 1601 Trapelo Rd., Suite 178, Waltham, MA 02451 North America United States of America https://invivyd.com/#contact |
IgG1 lambda2. Adagio Therapeutics, Inc. published in vitro and in vivo data in Science on its lead antibody candidate, ADG2, which demonstrated similar or higher potency against SARS-CoV-2 compared to other monoclonal antibodies (mAbs) in clinical development and strong binding to all known SARS-CoV-2 variants. Uniquely, ADG2 also showed broad and potent neutralization against a range of sarbecoviruses that pose a threat to humans and protective efficacy in murine models of SARS and COVID-19. The data show that ADG2 effectively binds to and has the potential to protect against common circulating SARS-CoV-2 variants as well as future SARS-related viruses with pandemic potential. Adagio’s half-life engineered version of ADG2, called ADG20, could offer protection against COVID-19 for up to a year. Adagio expects ADG20 to enter Phase 1 clinical studies in early 2021. https://science.sciencemag.org/content/early/2021/01/22/science.abf4830
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |