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the official website of the antibody society

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

November 30, 2020 by Pam Borghardt

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!

Filed Under: AIRR Community Tagged With: Adaptive Immune Receptor Repertoire Community

FDA approves naxitamab-gqgk (DANYELZA®)

November 26, 2020 by Janice Reichert

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.

Filed Under: Antibody therapeutic, Food and Drug Administration Tagged With: antibody therapeutics, approved antibodies, Food and Drug Administration, naxitamab

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

November 24, 2020 by Pam Borghardt

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!

Filed Under: AIRR Community, COVID-19, Uncategorized Tagged With: Adaptive Immune Receptor Repertoire Community, Meetings

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

November 22, 2020 by Janice Reichert

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.

Filed Under: Antibody therapeutic, COVID-19 Tagged With: antibody therapeutics, COVID-19, Food and Drug Administration, SARS-CoV-2

Antibody Engineering & Therapeutics Poster Competition Winners Announced

November 15, 2020 by Janice Reichert

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.

Filed Under: Award for Excellence, The Antibody Society Tagged With: antibody engineering, antibody therapeutics

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