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AIRR Community and PrecisionFDA COVID-19 Precision Immunology App-a-thon

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The AIRR Community is helping to lead the PrecisionFDA COVID-19 Precision Immunology App-a-thon.  

This is part of the “precisionFDA Challenges” program, which is designed to engage and improve software that analyzes NGS (next generation sequencing data) through community challenges. There were 68 bioinformaticians pre-registered for the Precision Immunology Challenge, and more are expected to join as the app-a-thon continues.  These “citizen scientists” will form teams to design software that will make AIRR-seq data more available and accessible for immunologists to realize the promise of immunological big data for improved diagnostics and therapeutics in immunotherapy.

The Precision Immunology Challenge uses AIRR-seq repertoire data from COVID-19 patients downloaded from the AIRR Data Commons (VDJServer and iReceptor Public Archive) through the iReceptor Gateway. These data sets have been carefully chosen to include data on patient demography and clinical outcome in order to illuminate the relationship between personalized adaptive immunity molecular data and COVID-19 disease variables.

The AIRR Community Diagnostics Working Group published a blog post as part of this effort, explaining the possible uses of AIRR-seq data in the clinic in the near future.

The app-a-thon runs through February 2021 at which time the apps will be judged for usability, impact and innovation.

 

FDA approves ansuvimab-zykl for Ebola virus infection

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On December 21, 2020, the US Food and Drug Administration approved Ebanga (ansuvimab-zykl) for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga had been granted US Orphan Drug designation and Breakthrough Therapy designations. Ansuvimab is a human IgG1 monoclonal antibody that binds and neutralizes the virus.

The safety and efficacy of Ebanga were evaluated in the multi-center, open-label, randomized controlled PALM trial. In this study, 174 participants (120 adults and 54 pediatric patients) with confirmed Ebolavirus infection received Ebanga intravenously as a single 50 mg/kg infusion and 168 participants (135 adults and 33 pediatric patients) received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 174 patients who received Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control.

Ebanga is the 12th 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.

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.

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.

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.