Please register today and don’t forget to sign up to present at one of the live virtual poster sessions or the software tool demonstration. 50% off registration discount codes were sent to all AIRR members on November 2nd – check your email! Be sure to download the event web app to get the latest updates on speakers, posters and demos. Looking forward to seeing everyone virtually at AIRR Community Meeting V: Zooming in to the AIRR Community, December 8-10, 2020!
Join the AIRR Community Slack Workspace!
The AIRR Community is now using Slack as a communication tool to promote idea sharing and explore questions related to AIRR research.
Please email the AIRR-C Communications Sub-Committee via communications@airr-community.org to request an invite and join the conversation. In your email, please specify the email address you’d like us to use for the invite.
Chat with you soon!
Accepting AIRR Executive Sub-committee Nominations Now!
AIRR Executive Sub-committee Elections for Chair-Elect and Executive Members are taking place soon.
To nominate an individual to serve on the AIRR-C Executive SC, the nominator as well as the nominee need to be members of the AIRR Community and the nominee must be willing to serve on the AIRR-C Executive SC. For complete details about the nomination process follow this link.
Please nominate suitable candidates by Oct 31st using this survey.
FDA approves Inmazeb for Ebola virus infection
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.
Emergency use authorization requests for anti-SARS-CoV-2 antibodies under FDA review
On October 7, 2020, Eli Lilly and Company and Regeneron announced that they have submitted requests to the U.S. Food and Drug Administration (FDA) for emergency use authorizations (EUA) of their anti-SARS-CoV-2 monoclonal antibodies.
Lilly’s EUA request is for bamlanivimab (LY-CoV555) monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. According to the company, up to 100,000 doses of 700 mg LY-CoV555 monotherapy may be available in October, and one million doses available in Q4 2020.
The combination of LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in an outpatient setting is also being evaluated. Lilly anticipates submission of an EUA request for combination therapy in November, and may have data to support a biologics license application submission for combination therapy as early as Q2 2021.
Regeneron’s EUA request is for REGN-COV2, which is a combination of two anti-SARS-CoV-2 monoclonal antibodies (REGN10933 and REGN10987). 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 that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. At the time of the EUA request, Regeneron had doses available for ~ 50,000 patients, and expects to have doses available for a total of 300,000 patients within several months.
The Antibody Society is tracking the progress of recombinant biologic COVID-19 interventions in preclinical and clinical studies. Summary data for all anti-SARS-CoV-2 antibodies in clinical studies can be found here.
