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FDA approves naxitamab-gqgk (DANYELZA®)

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On November 25, 2020, Y-mAbs announced that the FDA approved naxitamab-gqgk (DANYELZA®) 40mg/10ml in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The approval for this indication was granted under FDA’s accelerated approval regulations based on the overall response rate and duration of response.

Naxitamab, a humanized anti-GD2 IgG1k antibody was developed by Memorial Sloan Kettering Cancer Center and licensed to Y-mAbs Therapeutics. FDA granted Breakthrough Therapy and  Rare Pediatric Drug designations to naxitamab for the treatment of patients with neuroblastoma, and naxitamab was granted Orphan Drug designations in the EU and US for this indication.

DANYELZA® is the 10th antibody therapeutic to be granted a first approval in the US or EU in 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Anti-SARS-CoV-2 casirivimab and imdevimab (REGN-COV2) authorized in the US for COVID-19

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On November 20, 2020, the US Food and Drug Administration authorized the emergency use of casirivimab and imdevimab (REGN-COV2), both of which are recombinant human IgG1 monoclonal antibodies that target the receptor binding domain of the spike protein of SARS-CoV-2. This antibody cocktail has been shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

After reviewing the analysis of Phase 1 and 2 data from the ongoing Phase 1/2/3 NCT04425629 study, the agency concluded that “it is reasonable to believe that casirivimab and imdevimab, administered together, may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of casirivimab and imdevimab, administered together, outweigh the known and potential risks of such product.”

The EUA letter further states that distribution of REGN-COV2 will be directed by the U.S. government, and its EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated or the EUA is revoked. The authorized dosage is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single intravenous (IV) infusion over at least 60 minutes via pump or gravity as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Regeneron was granted a $450 million contract to manufacture and supply REGN-COV2 by the US government, which has committed to making the doses available to Americans for free. The agreement covers a fixed number of bulk lots, as well as fill/finish and storage activities. Delivery of REGN-COV2 drug product started during the third quarter of 2020, and the company expects to have ~ 80,000 doses available by the end of November, ~200,000 total doses ready by the first week of January 2021, and ~ 300,000 total doses ready by the end of January 2021.

Antibody Engineering & Therapeutics Poster Competition Winners Announced

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Congratulations to our winners!

To recognize the research activities of promising student and postdoctoral attendees of Antibody Engineering & Therapeutics, The Antibody Society sponsors a competition for members who submit posters for display at the meeting. Our judges select the best work based on originality, relevance and perceived impact on the field of antibody research and development.

This year, our judges selected one student and one postdoc winners who receive: 1) complimentary registration to all conference sessions; 2) an opportunity to give a short oral presentation of their work in one of the conference sessions; and 3) a lovely crystal award.

The winners of the contest are:

Felix Goerdeler, Max Planck Institute of Colloids and Interfaces, Germany

Poster title: Fighting protozoan parasites using carbohydrate-binding nanobodies

Dr. Nicolas Bery, Cancer Research Centre of Toulouse, France

Poster title: Discovery of a potent KRAS macromolecule degrader specifically targeting tumours with mutant KRAS

Please join us for the virtual Antibody Engineering & Therapeutics  conference on December 14-16, 2020.

Society members receive a 15% discount on the registration fee. Contact us at membership@antibodysociety.org for the code.

Anti-SARS-CoV-2 bamlanivimab authorized in the US for emergency use

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On November 9, 2020, the US Food and Drug Administration authorized the emergency use of anti-SARS-CoV-2 bamlanivimab (LY-CoV555, LY3819253). The agency stated that “it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab when used to treat COVID-19 in such patients outweigh the known and potential risks of such product.”

Bamlanivimab is a human IgG1 antibody directed against the receptor binding domain of the spike protein of the SARS-CoV-2 coronavirus. AbCellera and Eli Lilly and Company partnered on the discovery and development of the antibody, which was derived from B cells of convalescent patients. The EUA was based on review of the topline data from the planned interim analysis of BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebo-controlled, Phase 2 dose-finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19.

The EUA letter indicates that distribution of the authorized bamlanivimab (700 mg/20 mL) will be controlled by the United States Government for use consistent with the terms and conditions of the EUA, and that the EUA is effective only while circumstances exist justifying the authorization of emergency use during the COVID-19 pandemic.

FDA approves Inmazeb for Ebola virus infection

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On October 14, 2020, FDA approved the triple antibody cocktail of atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) for the treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. Atoltivimab, maftivimab, and odesivimab are IgG1 antibodies that bind glycoprotein on the surface of Ebola virus, thereby blocking attachment and entry of the virus into cells. FDA granted the atoltivimab, maftivimab, and odesivimab cocktail Breakthrough Therapy and Orphan Drug designations for the approved indication. Inmazeb was developed by Regeneron.

The effects of Inmazeb were evaluated in adult and pediatric patients with confirmed infections that occurred during an Ebola virus outbreak in the Democratic Republic of the Congo in 2018 and 2019. In the Pamoja Tulinde Maisha (PALM) study (NCT03719586), a 4-arm trial evaluating investigational therapies for Ebola virus infection initiated in November 2018, 154 patients received Inmazeb  as a single IV infusion of 50 mg of each monoclonal antibody. The primary efficacy endpoint was 28-day mortality. At this timepoint, 33% of those who received Inmazeb had died vs 51% of those who received a control. Inmazeb was also made available in an expanded access program, which included an additional 228 patients who received Inmazeb. The PALM study was sponsored by the US National Institute of Allergy and Infectious Diseases, with collaborators from Institut National de Recherche Biomédicale (Democratic Republic of Congo); the Alliance for International Medical Action (Senegal); International Medical Corps, Los Angeles (US); Epicentre, Médecins sans Frontières, (France); and the World Health Organization (Switzerland).

Inmazeb is the 9th antibody therapeutic to be granted a first approval in the US or EU in 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.