The Antibody Society, in collaboration with the Chinese Antibody Society, is tracking over 160 biotechnology-derived protein-based COVID-19 interventions in preclinical and clinical development. Our ongoing collaboration is designed to provide data, analysis and commentary relating to COVID-19 interventions to the scientific community.
Our COVID-19 Antibody Therapeutics Tracker includes data relating to COVID-19 biologics discovery programs and specific molecules in preclinical and clinical development. The database includes:
- Drug code and other names
- Target and format
- Development status
- Sponsoring organization and partners
Publicly available data for commercially sponsored, biotechnology-derived biologic COVID-19 interventions can be downloaded here. This data was last updated on November 9, 2020.
FDA documents relating to Emergency Use Authorizations can be found here.
The Antibody Society collaborated with the Chinese Antibody Society on a recently published paper about the Tracker:
Lifei Yang, Weihan Liu, Xin Yu, Meng Wu, Janice M Reichert, Mitchell Ho. COVID-19 Antibody Therapeutics Tracker: A Global Online Database of Antibody Therapeutics for the Prevention and Treatment of COVID-19. Antibody Therapeutics, tbaa020, https://doi.org/10.1093/abt/tbaa020
The “Coronavirus in the Crosshairs” series provides analyses and commentary on the ongoing discovery and development of COVID-19 interventions for broad use, including small molecule and biologic drugs, and vaccines. Specific information about recombinant anti-SARS-CoV-2 antibodies in clinical studies and those that might enter clinical studies soon can be found below.
Clinical studies evaluating anti-SARS-CoV-2 monoclonal antibodies
|Sponsors||Drug code||Status||Trial ID||Est. start||Est. primary completion|
|Junshi Biosciences / Eli Lilly and Company||JS016, LY3832479, LY-CoV016||Phase 2||NCT04441918;
|Dec 2020; 10/2/2020;
|Tychan Pte. Ltd.||TY027||Phase 1||NCT04429529||6/9/2020||Oct 2020|
|Brii Biosciences||BRII-196||Phase 1||NCT04479631||7/12/2020||Mar 2021|
|Brii Biosciences||BRII-198||Phase 1||NCT04479644||7/13/2020||Mar 2021|
|AbbVie||ABBV-47D11||Phase 1 pending||NCT04644120||11/27/2020||May 2021|
|Sorrento Therapeutics, Inc.||COVI-GUARD (STI-1499)||Phase 1||NCT04454398||9/17/2020||Feb 2021|
|Mabwell (Shanghai) Bioscience Co., Ltd.||MW33||Phase 1||NCT04533048||8/7/2020||Dec 2020|
|HiFiBiO Therapeutics||HFB30132A||Phase 1||NCT04590430||Oct 2020||July 2021|
|Ology Bioservices||ADM03820||Phase 1 pending||NCT04592549||11/16/2020||Aug 2021|
|Hengenix Biotech Inc||HLX70||Phase 1 pending||NCT04561076||12/9/2020||Sep 2021|
|U. Cologne / Boehringer Ingelheim||DZIF-10c||Phase 1 /2 pending||NCT04631705;
|Sorrento Therapeutics, Inc.||COVI-AMG (STI-2020)||Phase 1 /2 pending||NCT04584697||Dec 2020||April 2021|
|Beigene||BGB DXP593||Phase 1;
Phase 2 pending
|AstraZeneca||AZD7442 (AZD8895 + AZD1061)||Phase 1;
Phase 3 pending
|Sep 2021; 7/31/2021;
Nov 2020; 12/23/2020;
|Phase 2/3||NCT04545060||8/27/2020||Jan 2021|
|AbCellera / Eli Lilly and Company||
combination of LY-CoV555 with LY-CoV016 (LY3832479)
|Regeneron||REGN-COV2 (REGN10933 + REGN10987)||EUA*||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 granted by US Food and Drug Administration
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 will compare the effects of LY3819253 vs. remdesivir vs placebo in 10,000 hospitalized patients. NIAID and Lilly are collaborators in this study.
- 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.
- 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.
- 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.
- 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.
- COVI-GUARD (STI-1499). Sorrento Therapeutics Inc. is developing COVI-GUARD (STI-1499), an anti-SARS-CoV-2 antibody that has shown 100% inhibition of the virus in laboratory tests.
- NCT04454398 is a randomized, placebo-controlled study to evaluate safety, pharmacokinetics, preliminary efficacy of 3 dose levels of a single dose of STI-1499 (COVI-GUARD) in COVID-19 hospitalized patients.
- ADM03820. Ology Bioservices is developing ADM03820, which is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies.
Clinical entry anticipated during December 2020 – Q1 2021
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.
As of the end of September 2020, more than 20 organizations have announced that their anti-SARS-CoV-2 molecules may enter clinical study by the end of 2020. We will provide updates here and through our “Antibody News You Should Know” as more information becomes available in the future.
Adagio Therapeutics, Inc.
- Adagio, a spin out of Adimab, LLC, is developing antibody candidates that have been engineered and optimized to provide broad protection against SARS-CoV-2, SARSCoV-1, and additional circulating bat coronaviruses. Their lead program is expected to enter the clinic by the end of 2020.
- Distributed Bio 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.
CORAT Therapeutics GmbH
- Corat, a spin out of Yumab, is advancing the development of COVID-19 antibody drug candidates. The company will continue the pre-clinical development of the lead antibody drug candidate to potentially begin clinical development by the end of 2020.
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.
Memo Therapeutics AG
- Memo Therapeutics has identified several SARS-CoV-2-specific virus-neutralizing antibodies with the potential for development as a COVID-19 immunotherapy. The most potent of these antibodies will now undergo clinical development as passive immunotherapy for COVID-19, with a clinical proof-of-concept anticipated for Q4 2020.
Vir Biotechnology, Inc. / Humabs Biomed SA, with partners
- VIR-7832 has demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live virus-cellular assays. In collaboration with GlaxoSmithKline plc., Vir plans to proceed directly into a Phase 2 clinical trial by the end of 2020.
- Vir Biotechnology also has partnership agreements involving antibody engineering and manufacturing with Xencor, Biogen, WuXi Biologics, and Samsung Biologics.
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 expects to commence Phase 1 trials in Q3 2020.
- 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. Their goal is to prepare antibodies for human clinical trials by Summer 2020.
- 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.
- SI-F019 is composed of ACE2 fused to an immunoglobulin Fc that has been engineered to eliminate effector functions. It mimics the naturally occurring human ACE2 protein target of SARS-CoV-2, but has a bivalent architecture and extended half-life. Systimmune aims to initiate a clinical trial with study sites in the US and China by December 2020.
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.