The Antibody Society is tracking over 200 biotechnology-derived protein-based COVID-19 interventions in preclinical and clinical development. Of the anti-SARS-CoV-2 monoclonal antibodies in development, over 30 have entered clinical study. An overview of these are included in the table below.
For details regarding anti-SARS-CoV-2 biologics development, see: Strohl W.R., Ku Z., An Z. et al. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants. BioDrugs (2022).
FDA documents relating to Emergency Use Authorizations can be found here.
Please cite our data! Information on this website should be attributed to The Antibody Society (antibodysociety.org)
Anti-SARS-CoV-2 mAbs in clinical studies or approved for use
|Sponsors||Drug code||Most advanced study||Trial IDs||Est. start||Est. primary completion|
|Memo Therapeutics||MTx-COVAB36||Phase 1 pending||NCT05351437||May 2022||Jun 2022|
|IGM Biosciences, Inc.||IGM-6268||Phase 1||NCT05160402; NCT05184218||Dec 2021; Jan 2022||Mar 2022; Nov 2022|
|Celltrion||CT-P63||Phase 1||NCT05017168||Sep 2021||Oct 2021|
|Exevir Bio BV||XVR011||Phase 1/2||NCT04884295||Aug 2021||Apr 2022|
|Jemincare Group||JMB2002||Phase 1||ChiCTR2100042150||NA||NA|
|Luye Pharma Group Ltd||LY-CovMab||Phase 1||NCT04973735||Nov 2022||May 2021|
|AbbVie||ABBV-47D11||Phase 1||NCT04644120||11/27/2020||Aug 2021|
|HiFiBiO Therapeutics||HFB30132A||Phase 1||NCT04590430||Oct 2020||Jul 2021|
|Immunome, Inc.||IMM-BCP-01||Phase 1 pending|
|Zydus Cadila||ZRC-3308||Phase 1 pending||NA||NA||NA|
|Hengenix Biotech Inc||HLX70||Phase 1 pending||NCT04561076||12/9/2020||Sep 2021|
|CORAT Therapeutics||COR-101||Phase 1 /2||NCT04674566||1/31/2021||Oct 2021|
|Vir Biotechnol./||VIR-7832||Phase 1 /2||NCT04746183||1/31/2021||Nov 2021|
|Immune Biosolutions||IBIO-123||Phase 2||NA||NA||NA|
|AbCellera / Eli Lilly and Company||LY3819253, LY3832479||Phase 2||NCT04634409||NA||Aug 2021|
|Sorrento Therapeutics, Inc.||COVI-AMG (STI-2020)||Phase 2||NCT04734860||April 2021||Sep 2021|
|Junshi Biosciences / Eli Lilly and Company||JS016, LY3832479, LY-CoV016||Phase 2||NCT04441918;
|Dec 2020; 10/2/2020;
|Mabwell (Shanghai) Bioscience Co., Ltd.||MW33||Pivotal
|Toscana Life Sciences Sviluppo s.r.l.||MAD0004J08||Phase 2/3||NCT04932850;
|Bristol-Myers Squibb, Rockefeller University||C144-LS and C-135-LS||Phase 2/3||NCT04700163;
|1/11/2021; TBD||June 2021; TBD|
|Sinocelltech Ltd.||SCTA01 + SCTA01C||
|Regeneron||REGN14256 + imdevimab||Phase 1/2/3||NCT05081388||Nov 2021||Nov 2022|
|Adagio Therapeutics||ADG20||Phase 2/3||Mar 2021;
|Ology Bioservices||ADM03820||Phase 2/3||NCT05142527||Dec 2021||Apr 2022|
|Tychan Pte. Ltd.||TY027||Phase 3||6/9/2020;
|Approved in China; EUA requested||NCT04479644;
|Eli Lilly and Company||Bebtelovimab||EUA*||NCT04634409||NA||Aug 2021|
|AstraZeneca||AZD7442 (AZD8895 + AZD1061); Evusheld||EUA*||8/17/2020; 11/17/2020;
|Sep 2021; Feb 2022;
Approved in Republic of Korea and EU
Nov 2020; 12/23/2020;
GSK4182136; Sotrovimab; Xevudy
EUA* granted but withdrawn; Approved in Australia, UK, EU
|AbCellera / Eli Lilly and Company||
combination of LY-CoV555 with LY-CoV016 (LY3832479)
|EUA* for bamlanivimab/ etesevimab combination therapy granted but withdrawn||5/28/2020; 6/13/2020;
|Regeneron||REGN-COV2 (REGN10933 + REGN10987): Ronapreve||EUA* granted but withdrawn; Approved in Japan, UK, EU, Australia||NCT04425629 (Phase 1/2); NCT04426695 (Phase 1/2); NCT04452318 (Phase 3)||6/16/2020; 6/10/2020; 7/13/2020||12/19/2020; 1/25/2021; 6/15/2021|
*Emergency Use Authorization; FDA documents relating to Emergency Use Authorizations can be found here.
Anti-SARS-CoV-2 monoclonal antibodies in clinical study
- LY-CoV555 (LY3819253) and combination of LY-CoV555 with LY-CoV016 (LYLY3832479). On June 1, 2020, Eli Lilly and Company announced LY-CoV555 (LY3819253), an anti-SARS-CoV2 IgG1 antibody, has been administered to COVID-19 patients. On October 7, 2020, Lilly announced that they submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of LY-CoV555, which was granted on November 9, 2020. Documents relating to the EUA can be found here.
- LY3819253 is a human antibody that targets the SARS-CoV-2 spike protein. It was derived from human B cells from convalescent patients.
- The NCT04427501 Phase 2 study has 3-arms: 1) LY-CoV555 (LY3819253); 2) combination of LY-CoV555 with LY-CoV016 (LYLY3832479); and 3) placebo. The study will evaluate the efficacy and safety of LY3819253 and LY3832479 in participants with mild to moderate COVID-19 illness
- The NCT04497987 Phase 3 trial will evaluate the efficacy and safety of LY3819253 in preventing SARS-CoV-2 infection and COVID-19 in skilled nursing and assisted living facility residents and staff. NIAID and Lilly are collaborators in this study.
- The NCT04501978 Phase 3 trial is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. One study arm compared the effects of LY3819253 vs. remdesivir vs placebo in hospitalized patients. The DSMB reviewed data from the trial on Oct. 26, 2020 and recommended no further participants be randomized to receive LY-CoV555 and that the investigators be unblinded to the data. This recommendation was based on a low likelihood that the intervention would be of clinical value in this hospitalized patient population.
- The NCT04518410 Phase 2/3 “Adapt Out COVID” study is an adaptive platform treatment trial for outpatients With COVID-19. NIAID and Lilly are collaborators in this study.
- REGN-COV2 (REGN10933 + REGN10987). On June 11, 2020, Regeneron Pharmaceuticals, Inc. announced the start of the first clinical trial of REGN-COV2 for the prevention and treatment of COVID-19. On October 7, 2020, Regeneron announced that they submitted a request to the U.S. Food and Drug Administration (FDA) for an EUA for REGN-COV2, which was granted on November 20, 2020.
- REGN-COV2 is a cocktail of the human antibodies REGN10933 and REGN10987, which were derived from Regeneron’s parallel efforts using both humanized VelocImmune® mice and blood samples from recovered COVID-19 patients to generate a large and diverse collection of antibodies targeting multiple different regions of the receptor-binding domain of the SARS-CoV-2 spike protein. Two papers describing the creation of REGN-COV2 and its anti-viral activity have been accepted for publication in Science.
- The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure and uninfected people with close exposure to a COVID-19 patient. The placebo-controlled trials will be conducted at multiple sites. The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies.
- VIR-7831/GSK4182136. Vir Biotechnology, Inc. and GlaxoSmithKline plc developed VIR-7831, which is a human anti-SARS-CoV-2 antibody.
- The Phase 2/3 study will assess VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
- The NCT04501978 Phase 3 trial is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. A study arm will include VIR-7831.
- CT-P59. On July 17, 2020, Celltrion announced the start of a Phase 1 study of CT-P59.
- The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital. The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year.
- A Phase 2/3 study investigating CT-P59 as a COVID-19 preventative measure was initiated in late September 2020.
- On December 29, 2020, Celltrion announced that they had submitted an application for conditional marketing authorisation of CT-P59 to the Korean Ministry of Food and Drug Safety.
- On February 5, 2021, South Korea granted conditional approval.
- AZD7442 (AZD8895 + AZD1061). AstraZeneca licensed coronavirus-neutralizing antibodies from Vanderbilt University, and advanced two (AZD8895 and AZD1061) into clinical development as a potential combination therapy (AZD7442) for the prevention and treatment of COVID-19.
- NCT04507256 is a Phase 1 double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of AZD7442 in healthy adults.
- On October 9, 2020, AstraZeneca announced 2 Phase 3 trials were due to start in the next few weeks.
- JS016. On June 7, 2020, Junshi Biosciences announced that a Phase 1 clinical study of JS016 in healthy volunteers had started in China.JS016 is a human monoclonal antibody that targets the SARS-CoV-2 spike protein and blocks binding of the virus to host cells. The antibody was identified by screening B cells from convalescent COVID-19 patients, and engineered to introduce LALA mutations to silence the Fc portion. JS016 was shown to provide protection from SARS-CoV-2 infection when administered to rhesus monkeys (Shi et al. Nature 2020).
- The Phase 1 clinical study will evaluate the tolerability, safety, pharmacokinetics and immunogenicity of JS016 in healthy volunteers.
- TY027. Tychan Pte. Ltd., based in Singapore, is developing TY027.
- NCT04429529 is a Phase 1 first-in-human, time lagged, randomized, placebo controlled, double blind, single ascending dose study of TY027 in healthy adult volunteers.
- BRII-96, BRII-98. Brii Biosciences initiated clinical studies of 2 human anti-SARS-CoV-2 antibodies in mid-July 2020.
- The Phase 1 studies are randomized, single-blind, placebo-controlled, single ascending dose escalation studies of the safety, tolerability, and pharmacokinetics of the antibodies administered intravenously to healthy adult volunteers.
- The NCT04501978 Phase 3 trial is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. Study arms will include BRII-96 and BRII-98.
- SCTA01. Sinocelltech Ltd. has developed a recombinant humanized anti-SARS-CoV-2 monoclonal antibody.
- NCT04483375 is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled, single ascending dose study of SCTA01 in healthy Chinese subjects.
- ADM03820. Ology Bioservices is developing ADM03820, which is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies.
- COR-101. CORAT Therapeutics is developing COR-101, a fully human monoclonal IgG antibody that binds a very broad area of the SARS-CoV-2 surface.
Clinical entry anticipated
Note: Our information is based on press releases or other public disclosures, and is subject to change at any time. Details for the specific molecules entering clinical studies may not be publicly available at this time. The organizations’ plans to start first-in-human studies are subject to review by regulatory authorities.
Numerous organizations have anti-SARS-CoV-2 molecules in preclinical development. As these molecules enter clinical study, we will provide updates here and through our “Antibody News You Should Know” as more information becomes available in the future.
- Centivax has engineered a panel of ultra-high affinity therapeutic antibodies to neutralize SARS-CoV-2. The work leveraged both the Distributed Bio SuperHuman 2.0 human antibody discovery technology and the Tumbler computational antibody optimization technology to discover thousands of antibodies against a novel virus in 9 weeks.
Cytovia Therapeutics, Inc.
- Cytovia is leveraging its own proprietary bi-functional technology and novel antibodies neutralizing or blocking SARS CoV2, designed by Macromoltek, a computational antibody discovery company. Their goal is to bring the best candidate to clinical trials by the end of the year 2020.
IMMUNOPRECISE ANTIBODIES LTD
- IMMUNOPRECISE ANTIBODIES LTD. has identified and analyzed neutralizing antibodies demonstrated to bind to the S1 and S2 domains of the SARS-CoV-2 spike protein, and has begun steps for the expression of the lead antibodies for pre-clinical and clinical manufacturing.
Sorrento Therapeutics, with partners
- COVI-SHIELD is a cocktail of three antibodies that together would recognize three unique regions of the SARS-CoV-2 Spike protein. The leading antibody, STI-1499, came from the company’s extensive library. Sorrento and Mount Sinai Health System are jointly developing this asset.
- Sorrento is also developing other potential antiviral therapies against coronaviruses, including COVIDTRAP (STI-4398) and ACE-MAB (STI-4920, CMAB020). Specific information about the dates of first-in-human clinical trials has not been divulged. COVIDTRAP (STI-4398) is a proprietary angiotensin-converting enzyme 2 (ACE2)-Fc fusion protein. ACE-MAB (STI-4920, CMAB020) is a proprietary bispecific fusion protein composed of a human antibody that targets the spike protein of SARS-CoV-2 with high affinity fused to a truncated ACE2 protein that binds to a different epitope of the spike protein. Sorrento Therapeutics, Inc. entered into an exclusive license agreement with Mabpharm Limited for the clinical development and commercialization of ACE-MAB for the potential treatment of COVID-19.
Vanderbilt University Medical Center, with partners
- Vanderbilt University Medical Center is working with numerous partners, including AstraZeneca, Twist Bioscience and its Twist Biopharma division, to discover anti-SARS-CoV-2 antibodies.
- IDBiologics has licensed IDB003, and is developing it to treat SARS-CoV-2 infection. IDBiologics intends to initiate a Phase 1 clinical trial of IDB003 in the third quarter this year.
Neurimmune AG and Ethris GmbH
- Neurimmune is identifying human anti-SARS-CoV-2 antibodies from B cells of recovered COVID-19 patients using its Reverse Translational Medicine platform. Using Ethris’ novel nucleic acid therapy platform, potent neutralizing antibodies will be translated into therapeutic SNIM®RNA product candidates for inhalation. The companies anticipate that the first product candidate may begin clinical testing in Q4 2020.