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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!

FDA approves Uplizna (inebilizumab-cdon) for NMOSD

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On June 11, 2020, the U.S. Food and Drug Administration approved Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)-antibody positive. This rare disease primarily affects the optic nerves and spinal cord. Uplizna is a humanized anti-CD19 monoclonal antibody developed by Viela Bio. By targeting CD19, Uplizna depletes CD19+ B cells and plasmablasts responsible for the production of autoantibodies directed against AQP4, thereby ameliorating symptoms of the disease.

The effectiveness of inebilizumab was demonstrated in the Phase 2/3 N-MOmentum trial (NCT02200770). This study enrolled 230 patients with and without the AQP4-IgG antibody who were randomized 3:1 to receive either 2 doses of 300 mg of inebilizumab as a monotherapy or placebo at Day 1 and Day 15, and then followed for a total of 28 weeks. The primary endpoint (time to first attack) and a majority of the secondary endpoints of the study were met. Of patients in the anti-AQP4 antibody positive group, 89% remained relapse-free during the post-treatment period, compared to 58% of the patients taking placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative. Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo.

Uplizna is the second antibody therapeutic to be approved in the US for NMOSD. FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive in June 2019. Soliris, which targets C5 was first approved by FDA in 2007 for paroxysmal nocturnal hemoglobinuria. A biologics license application for anti-IL6R satralizumab as a possible treatment for NMOSD is currently under review at FDA. More information about antibody therapeutics approved in the US and EU, and those in regulatory review, can be found here.

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.