The Antibody Society, in collaboration with the Chinese Antibody Society, is tracking over 130 recombinant 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
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.
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||Phase 1||NCT04441918||6/5/2020||12/11/2020|
|Tychan Pte. Ltd.||TY027||Phase 1||NCT04429529||6/9/2020||Oct. 2020|
|Sorrento Therapeutics, Inc.||COVI-GUARD (STI-1499)||Phase 1 pending||NCT04454398||Aug 2020||Jan 2021|
|AbCellera / Eli Lilly and Company||LY-CoV555, LY3819253||Phase 2||NCT04411628 (Phase 1); NCT04427501 (Phase 2)||5/28/2020; 6/13/2020||8/23/2020; 9/15/2020|
|Regeneron||REGN-COV2 (REGN10933 + REGN10987)||Phase 3||NCT04425629 (Phase 1/2); NCT04426695 (Phase 1/2); NCT04452318 (Phase 3)||6/9/2020; 6/12/2020; 6/30/2020||11/21/2020; 3/13/2021; 4/11/2021|
Anti-SARS-CoV-2 monoclonal antibodies in clinical study
- LY-CoV555, LY3819253. 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.
- LY3819253 is a human antibody that targets the SARS-CoV-2 spike protein. It was derived from human B cells from convalescent patients.
- The placebo-controlled study (NCT04411628) will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LY-CoV555 following a single dose in patients hospitalized with COVID-19.
- 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.
- 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.
- 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.
- 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.
- 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. This study is due to start in August 2020.
Clinical entry anticipated during June – December 2020
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 May 2020, more than 15 organizations have announced that their anti-SARS-CoV-2 molecules may enter clinical study during June to December 2020. We will provide updates here and through our “Antibody News You Should Know” as more information becomes available in the future.
- Celltrion has selected SARS-CoV-2 neutralizing antibodies and anticipates moving to first-in-human clinical trials in July 2020.
Vir Biotechnology, Inc. / Humabs Biomed SA, with partners
- VIR-7831 and VIR-7832 have 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 in July-September 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.
AstraZeneca, with partners
- In addition to applying their own substantial resources to the problem, AstraZeneca is also working with numerous partners (Vanderbilt University Medical Center, Chinese Academy of Sciences, United States Army Medical Research Institute of Infectious Diseases and the University of Maryland School of Medicine) to develop anti-SARS-CoV-2 antibodies. AstraZeneca is using all three potential sources for antibodies (i.e., in vitro libraries, patient B cells, immunized humanized mice), with the spike protein on the SARS-CoV-2 virus as the primary target being explored. AstraZeneca is aiming for clinical evaluation in July-September 2020.
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.
- SAB-185 is a transgenic cow-derived human polyclonal antibody therapy that is more consistent and easier to scale up than convalescent plasma. SAB immunizes the cows every 28 days, and plasma can be collected from each animal three times a month for a monthly total of about 35-45L. A clinical candidate may be ready as early as Summer 2020.
Yumab, with partners
- Using antibody libraries, Yumab and its Corona Antibody Team (CORAT) partners have identified human monoclonal antibodies with neutralizing activity against patient-derived coronavirus. Initiation of clinical studies is anticipated in H2 2020. CORAT is a consortium of academic and industrial organizations.
- YUMAB has also identified neutralizing human anti-SARS-CoV-2 antibodies as part of a partnership with Boehringer Ingelheim. Clinical study of a product candidate may be initiated by Fall 2020.
Brii Biosciences, with partners
- Brii Bioscience is using its expertise in infectious diseases to develop highly potent, neutralizing antibodies from convalesced patients that were identified by researchers at Tsinghua University, and 3rd People’s Hospital of Shenzhen. First-in-human clinical trials are planned for Q3 2020.
- Molecular Partners is developing a trispecific designed ankyrin repeat protein (DARPin®) that targets 3 parts of the spike protein of virus. Half-life extension will be provided via inclusion of a DARPin® domain that binds to human serum albumin. Two candidates shown to neutralize the virus have been identified and will be evaluated in vivo studies. Molecular Partners is preparing for initiation of clinical studies in H2 2020.
- 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.