The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

AIRR Community 2021 Plans Ratification Vote!

by

AIRR Community Working Groups and Sub-committees presented their 2020 reports and 2021 plans today at AIRR Meeting V: “Zooming in to the AIRR Community.” According to AIRR-C governance these plans must be ratified by the Community.
The reports and plans are available through the AIRR Meeting V meeting platform. Each report is attached to the agenda item that it corresponds to. If you are not registered for Meeting V but an eligible voting member you can access the report slides by logging in to the AIRR Community Resources section of the AIRR website.
Time is short – Voting closes at midnight PDT on December 9th!

Voting is now closed.

Vote by December 4th! AIRR-C Executive SC 2020 Election

by

AIRR-C Executive SC 2020 Election – It’s Time to Vote!!

With each major meeting interval of the AIRR Community, elections are held for leadership positions within the AIRR-C Executive Sub-committee. This year, per our governance, we have sought nominations for Executive SC Chair-Elect and up to three members of the Executive SC.  We are pleased to announce that we have a strong set of candidates and we are grateful to all the nominees for letting their name stand.

How to Vote:

Voting is now complete. Results are available here.

Election Timeline:

Voting opens: November 24, 2020
Polls close: December 4, 2020
Voting results announced: December 10, 2020 (last day of the AIRR-C meeting)

Thank you for all of the time you give to the AIRR Community and for participating in this election!

FDA approves naxitamab-gqgk (DANYELZA®)

by

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.

Register now for Pre-Meeting “AIRR-seq in the Pandemic!

by

AIRR-seq in the Pandemic:
AIRR Community/Tsinghua University Joint Meeting
A pre-meeting to AIRR-C Meeting V: Zooming in to the AIRR Community!

We are pleased to announce a meeting co-organized by the AIRR Community and Tsinghua University, which will mainly focus on Chinese researchers using AIRR-seq data to study the adaptive immune response, especially in COVID-19 patients. This event has been scheduled as a pre-meeting for the regular AIRR Community Meeting V: “Zooming in to the AIRR Community” which will be held virtually December 8-10th, 2020.  Professor Xiao Liu of Tsinghua University is organizing an in-person meeting of Chinese researchers in Shenzen, China on Sunday December 6, 2020, and researchers from North America and Europe will join this group virtually.

The Timeline:
The in-person meeting will convene all day Sunday, December 6th, 2020 in Shenzhen, China.  North American researchers will virtually introduce the AIRR-seq Community approach and present research on COVID-19 during the evening of Saturday, December 5th, including a welcome by the Chair of the AIRR Community Executive Sub-committee, Dr. Nina Luning Prak; Saturday evening in North America will correspond to the morning of Sunday, December 6th in Shenzhen.  In addition, on the morning of Sunday, December 6th in Europe, two members of the AIRR Community will join from Europe, including Victor Greiff; this will correspond to the afternoon of December 6th in Shenzhen. See the draft agenda below for further details on this complicated enterprise!  And please join us if you can, in this international effort to integrate this important sector of the immunogenetics community more closely with the AIRR Community

For complete details and agenda visit the Pre-Meeting web page.

This virtual meeting is free but registration is required.

Please register for this groundbreaking event!

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

by

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.