The Antibody Society

the official website of the antibody society

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

FDA approves MARGENZA™

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On December 16, 2020, the US Food and Drug Administration approved margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. MARGENZA is a chimeric IgG1 monoclonal antibody that binds to HER2. The antibody’s modified Fc region increases binding to the activating Fc receptor CD16A and decreases binding to the inhibitory Fc receptor CD32B,  which leads to greater in vitro antibody-dependent cell-mediated cytotoxicity and natural killer cell activation.

FDA’s approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial, which showed a statistically significant 24% reduction in the risk of disease progression or death with MARGENZA plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio [HR]=0.76; 95% CI, 0.59-0.98; P=0.033; median PFS 5.8 vs 4.9 months). The objective response rate  for MARGENZA plus chemotherapy was 22% vs 16% for trastuzumab plus chemotherapy.

MARGENZA is the 11th antibody therapeutic to be granted a first approval in the US or EU during 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.

Announcing the new AIRR Community Executive Sub-committee!

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As part of the recent AIRR-C Meeting V the Executive Sub-committee election results were announced. Thank you to all nominees for their interest and for letting their names stand and to the many community members that took the time to vote.
We would like to thank Nina Luning Prak for her excellent and tireless work as Chair these past 18 months.  We would also like to recognize Steve Kleinstein for his many years on Exec and for his long standing commitment to the AIRR Community.
Please welcome the new Executive:
Lindsay Cowell, University Texas Southwestern, USA – Chair
Nina Luning Prak, University of Pennsylvania, USA – Past Chair
Victor Greiff, University of Oslo, Norway – Chair-elect
Felix Breden, Simon Fraser University, Canada – Elected Member
Christian Busse – DKFZ, Germany – Elected Member
Encarnita Mariotti-Ferrandiz, – Sorbonne Universite, France – Elected Member

AIRR Community 2021 Plans Ratification Vote!

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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

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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®)

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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.