The Antibody Society

the official website of the antibody society

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

FDA approves Tezspire™ (tezepelumab-ekko) for severe asthma

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On December 17, 2021, Amgen announced that the U.S. Food and Drug Administration approved Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Tezepelumab (AMG157, MEDI-9929) is a human IgG2 antibody that targets a cytokine, thymic stromal lymphopoietin, that plays a key role in asthma inflammation. The drug was developed by Amgen in collaboration with AstraZeneca.

The approval was based in part on data from the randomized, placebo-controlled Phase 3 NAVIGATOR study (NCT03347279), which evaluated the effects of tezepelumab in adults and adolescents with severe uncontrolled asthma. In this study, patients received tezepelumab (210 mg; n=529) or placebo (n=532) SC every 4 weeks for 52 weeks. The primary outcome measure of the study, the annualized asthma exacerbation rate from baseline to Week 52, was met. For the tezepelumab group, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80 to 1.07), while the rate was 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001). Overall, data from the study indicated that, compared to those administered placebo, patients who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life.104 A pre-specified exploratory analysis showed that tezepelumab reduced the annualized asthma exacerbation rate in patients with nasal polyps by 86% (95% CI: 70, 93) and 52% (95% CI: 42, 61) in those without nasal polyps over 52 weeks compared to placebo given with standard of care.

Marketing applications for Tezspire are under regulatory review in the EU, Japan and several other countries around the world.

FDA approves VYVGARTô (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis

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On December 17, 2021, argenx SE announced that the US Food and Drug Administration approved VYVGARTô (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Efgartigimod is an IgG1 Fc fragment designed for increased affinity for the neonatal Fc receptor (FcRn). It competes with IgG to occupy FcRn and reduce overall IgG recycling. Efgartigimod was derived from the ABDEG (antibodies that enhance IgG degradation) technology developed by Prof. Sally Ward and colleagues.

FDA’s approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which met its primary endpoint. Trial results demonstrated that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001).

Marketing authorization applications for efgartigimod for the treatment of gMG are currently under review in Japan and the European Union, with anticipated decisions in the first quarter and second half of 2022, respectively.

The Antibody Society announces the election of key Officers and Board of Directors Chair

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The Antibody Society, Inc., an international non-profit trade association focused on the advancement of antibody research and development, is pleased to announce the election of Prof. E. Sally Ward as President, Dr. Janine Schuurman as Vice President, and Prof. Paul Parren as Chair of the Board of Directors. They will assume these roles on January 1, 2022.

Prof. Ward, Dr. Schuurman and Prof. Parren bring substantial experience and expertise to their new roles. They each have made seminal contributions to the field of antibody discovery and development, and have critical experience with building successful external collaborations, partnerships, and alliances, which are essential to the Society’s future growth. Prof. Parren is succeeding Dr. James S. Huston who founded the Society in 2007 and served as Chair of the Board until his passing in 2020.

Prof. Ward served as the Society’s Vice President during 2020-2021. On her election as President, she said, “I am delighted to be given the opportunity to serve as President for The Antibody Society. It is a particular pleasure to be following in the footsteps of my friend and colleague, Dr. Paul Carter, who has made enormous contributions to the Society during his term. I am very enthusiastic about working with our newly elected Vice President, Dr. Janine Schuurman, on the Executive Committee. The antibody field continues to deliver an ever-expanding repertoire of novel classes of therapeutics to treat human disease, and it is great to be involved in this exciting area!”

Dr. Schuurman stated, “The Antibody Society plays a key role in representing individuals and organizations involved in the antibody research and development and it is a great pleasure to be elected as Vice President of this important association. I’m looking forward to elevating the awareness of antibody science and therapeutics, our beloved field of research, which is getting more and more interdisciplinary and interconnected. I’m also excited about this opportunity to work with Prof. Sally Ward and Dr. Janice Reichert as part of the Society’s Executive Committee.”

Prof. Parren remarked, “I am honored to be elected as the Chair of the Board of The Antibody Society and serve to support the business of antibody therapeutic development by stimulating the interchange of ideas and education as well as by working with opinion leaders and policy makers to forward this exciting field.”

Sally Ward, Ph.D., Professor in Molecular Immunology and Director of Translational Immunology in the Centre for Cancer Immunology at the University of Southampton.

Prof. Ward’s research takes an interdisciplinary approach involving a combination of antibody/protein engineering, fluorescence imaging and in vivo studies to inform the design of antibody-based therapies for autoimmunity and cancer. In 1996, her laboratory identified the Fc receptor, FcRn, as a global regulator of IgG levels, leading to half-life extension and FcRn antagonist (Abdeg) technologies. These technologies have been licensed to biopharma, resulting in engineered, antibody-based therapeutics that are approved or are pending approval. Recent work in her laboratory has also described the generation of antibody-drug conjugates with engineered variable domains that have improved lysosomal delivery behavior.

Janine Schuurman, Ph.D., Senior Vice President, Head Antibody Research & Technology, Genmab

Dr. Schuurman is an expert in antibody biology and translational research. Following her passion to develop innovative antibody therapeutics, Dr. Schuurman joined Genmab in 2000. She currently heads the Research & Technology division, focusing on antibody biology research, the creation of novel antibody formats and their translation to antibody therapeutics. She is a co-inventor multiple antibody technology platforms including DuoBody®, HexaBody® and HexElect® technologies that enable the generation of bispecific and effector-function enhanced antibodies. These technologies are being applied to antibody therapeutics discovery programs at Genmab, as well as many leading pharmaceutical and biotechnology companies located worldwide. In addition, she is a co-inventor of several antibody therapeutic products in various stages of development and approved treatment options for patients.

Paul Parren, Ph.D., Executive Vice President and Head of R&D, Lava Therapeutics; Professor of Molecular Immunology at the Leiden University Medical Center

Prof. Parren is dedicated to translating antibody biology and immunotherapy knowledge into innovative therapeutics and technologies. He has a passion for investigating and understanding structure-function relationships and their application in antibody drug discovery and development. He was a postdoc and faculty member at The Scripps Research Institute in La Jolla, CA. From 2002-2017, he served in the position Scientific Director heading Genmab’s preclinical R&D, where he developed the scientific concepts and translation of the DuoBody® and HexaBody® technologies. He is an inventor of five marketed therapeutic antibodies, including canonical human antibodies, an antibody-drug conjugate and a bispecific antibody, approved for the treatment of various cancers and autoimmune inflammatory diseases. He is a tenured Professor of Molecular Immunology at the Leiden University Medical Center in Leiden, the Netherlands. He heads R&D at LAVA Therapeutics since 2018. Under his leadership, LAVA grew to a clinical stage biotechnology company with a successful initial public offering and Nasdaq listing in the US in March of 2021. He also provides drug development, patent, and investment advice as an independent consultant to (start-up) biotech and pharma and contributes to the program of leading scientific conferences in the antibody field.

About The Antibody Society

The Antibody Society, Inc. is an international non-profit trade association representing individuals and organizations involved in antibody research and development. The Society is an authoritative source of information about antibody therapeutics development, which is disseminated via our website, presentations, and publications. In addition, the Society organizes conferences and webinars on antibody research and development and related topics. The Society also serves as the home for the Adaptive Immune Receptor Repertoire Community, which focuses on developing standards and protocols for curating, analyzing and sharing antibody B and T cell receptors. As a business association, the Society can engage with government and international agencies such as the World Health Organization to discuss topics that are important to the antibody community, such as international naming conventions.

Three newly certified AIRR-compliant software tools: ImmuneML, CompAIRR and Dandelion

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The AIRR Community is excited to announce that three tools have recently been certified as compliant with the AIRR-C v1.0 standard for AIRR-Seq software tools. These are ImmuneML – an ecosystem for machine learning analysis of adaptive immune receptor repertoires, CompAIRR – a tool for ultra-fast comparison of adaptive immune receptor repertoires by exact and approximate sequence matching, and Dandelion – a tool for analyzing single cell BCR/V(D)J 10x Genomics data. 

In an effort to enable rigorous and reproducible immune repertoire research at the largest scale possible, the AIRR-C Software Working Group has established a standard to validate software tools using the AIRR-C Standards and meeting a series of interoperability and quality criteria. Developers interested in certifying their tools should complete the checklist and submit it to the AIRR-C Software Working Group for evaluation and ratification by its members.

More details can be found at the website AIRR Software WG – Guidance for AIRR Software Tools.

All compliant tools will be issued a badge and listed on the website AIRR Software WG – List of Tools Certified as Compliant. The list includes SONAR, ImmuneDB, Immcantation, ImmuneML, CompAIRR and Dandelion.

FDA grants emergency use authorization to anti-SARS-COV-2 mAb Evusheld

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On December 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Evusheld, comprising the combination of 2 human anti-SARS-CoV-2 IgG1k antibodies, was derived from B cells from convalescent patients after infection with SARS-CoV-2. Discovered by Vanderbilt University Medical Center, the antibodies bind to distinct sites on the SARS-CoV-2 spike protein. These antibodies were licensed to AstraZeneca in June 2020, and then engineered with mutations that extend half-life (YTE) and reduce Fc receptor and complement C1q binding (L234F, L235E, P331S). The primary data supporting the EUA came from the PROVENT clinical study, which is assessing the safety and efficacy of a single 300 mg dose of AZD7442 compared to placebo for the prevention of COVID-19. At the primary analysis, the study data showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI: 46, 90), compared to placebo.

Evusheld is the 4th anti-SARS-CoV-2 antibody product granted an EUA. See our COVID-19 Biologics Tracker for information about other anti-SARS-CoV-2 antibodies.