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Anti-IL-6R levilimab registered as COVID-19 treatment in Russia

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On June 11, 2020, Biocad announced that the Ministry of Health of the Russian Federation registered levilimab (trade name Ilsira) for patients with severe COVID-19. Developed by Biocad, levilimab is a human monoclonal antibody targeting membrane-bound and soluble forms of the interleukin 6 receptor. It was originally developed for treatment of rheumatoid arthritis. Levilimab received state approval for COVID-19 on June 5, 2020 through a fast-track mechanism according to Decree No. 441 of the Government of the Russian Federation, effective as of April 4, 2020.

The efficacy and safety of levilimab (BCD-089) in patients with severe COVID-19 is being evaluated in a Phase 3 multicenter, randomized, double-blind, placebo-controlled, adaptively designed clinical trial (NCT04397562). Initiated on April 24, 2020, the study includes 204 participants who received a single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy. According to Biocad, the results of a clinical trial of the drug demonstrate that levilimab therapy can significantly reduce mortality among patients with COVID-19.

Antibodies to Watch in a Pandemic

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Broadcast Date: June 30, 2020
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

The extraordinary scope and scale of the COVID-19 pandemic has elicited extraordinary responses world-wide. Organizations located across the globe have mobilized teams to research the SARS-CoV-2 virus and COVID-19, conduct clinical studies of repurposed biologics, and research and develop anti-SARS-CoV-2 biologics. Disruptions at companies and regulatory agencies, however, have raised concerns about the effects of the pandemic on possible approvals of non-COVID-19 antibody therapeutics.

In this webinar, Dr. Janice Reichert (The Antibody Society) will provide an update on non-COVID-19 antibody therapeutics approved so far in 2020, and those that might be approved by the end of the year. She will also discuss the ~ 140 biologics currently in development for COVID-19, which includes over 55 repurposed biologics and over 85 anti-SARS-CoV-2 biologics.

Additionally, Dr. Thomas Schirrmann (YUMAB) will present a case study of an academic and industrial consortium for the fast-track development of a SARS-CoV-2 antibody therapy. He will highlight the challenges of discovering and developing an antibody drug during the present pandemic.

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert speakers.

Speakers: Dr. Thomas Schirrmann and Dr. Janice Reichert
Date: June 30th, 11am EST, 5pm CEST.

Click Here to Register!

Anti-SARS-CoV-2 REGN-COV2 enters clinical study

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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.

REGN-COV2 is the 3rd anti-SARS-CoV-2 antibody-based drug to enter clinical study in the past 2 weeks. On June 1, 2020, Eli Lilly and Company announced LY-CoV555 had entered clinical study, and on June 7. 2020, Junshi Biosciences announced JS016 had entered clinical study.

Anti-SARS-CoV-2 antibody JS016 enters first clinical study

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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 clinical study will evaluate the tolerability, safety, pharmacokinetics and immunogenicity of JS016 in healthy volunteers. If the Phase 1 study shows the antibody can be administered safely, Junshi Biosciences intends to start another clinical study in that will assess JS016’s ability to prevent and treat COVID-19.

Junshi and Eli Lilly and Company are collaborating to co-develop JS016, with Junshi leading clinical development in China and Lilly leading clinical development in the rest of the world. The antibody was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Sciences.

First anti-SARS-CoV2 antibody therapeutic enters clinical study

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On June 1, 2020, Eli Lilly and Company announced LY-CoV555, an anti-SARS-CoV2 IgG1 antibody,  has been administered to COVID-19 patients. LY-CoV555 is the first antibody specifically targeting SARS-COV-2 to enter clinical study.
The antibody was developed via a collaboration between Lilly and AbCellera. AbCellera,  with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, isolated single B cells from convalescent patients, identified a pool of ~500 candidate antibodies against the virus’ spike protein and selected leads from this pool. Lilly scientists further developed LY-CoV555 in just three months. The placebo-controlled study (J2W-MC-PYAA) will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LY-CoV555 following a single dose in patients hospitalized with COVID-19. Results are anticipated by the end of June 2020. The company intends to test LY-CoV555 and other neutralizing antibodies against SARS-CoV-2 over the next several months as monotherapy or antibody cocktails for  COVID-19.

As detailed in “Coronavirus in the crosshairs, Part 9“, more than 15 organizations have announced that their anti-SARS-CoV-2 molecules may enter clinical study during June to December 2020. The abundance of potential clinical candidates has enabled some organizations, including Eli Lilly and Company, Sorrento Therapeutics, Vir Biotechnology, Vanderbilt University Medical Center and Yumab, to engage in multiple partnerships, thereby allowing rapid development of multiple assets. Further information about other anti-SARS-CoV-2 antibodies that might enter clinical study soon can be found here.