The Antibody Society

the official website of the antibody society

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

AIRR-C Meeting VI – Registration Is Live!

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The AIRR-C Meetings Sub-committee is excited to announce that registration is live!  Be sure to sign up soon to take advantage of the early bird discount!

AIRR Community Meeting VI “Exploring New Frontiers” will be held in La Jolla, CA from May 17-19, 2022.

REGISTER NOW

Exploring New Frontiers:  This meeting has two themed “Challenge Sessions” meant to:
(i) Initiate and implement a strategic plan for the AIRR Community that integrates the Working Groups’ activities toward the central goal of universally accepted AIRR-seq data standards;
(ii) Introduce the Community to multidimensional systems approaches for characterizing immune responses, and how AIRR-seq data can benefit such approaches.

 

Meetings and presentations will take place at the Hilton La Jolla Torrey Pines and a hotel room block has been arranged at a discounted rate. The meeting will provide opportunities for investigators and trainees to network, participate in AIRR Community Working Groups and Sub-committee meetings, enjoy world class presentations, poster sessions, and deep dive tutorials.

Sign up today!

Untangling Pandemics in a Data-Driven World. The Evolution of SARS-CoV-2

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Antibody Engineering & Therapeutics, held in December 2021, offered many opportunities to hear exciting and informative presentations by experts in the field. We are pleased to present here a summary of a plenary lecture by Prof. Kristian Andersen (Scripps Research Institute), kindly written by Dr. Czeslaw Radziejewski.

 

Untangling Pandemics in a Data-Driven World. The Evolution of SARS-CoV-2.
Kristian Andersen, Professor of Immunology and Microbiology, Scripps Research Institute

Professor Andersen’s lab conducts genomic epidemiology of different viruses using miniaturized PCR testing and large-scale genomic sequencing. Previously, his lab studied Lassa, West Nile, Ebola, and Zika viruses, and now the lab is examining SARS-CoV-2. The goal of the research to understand the emergence of new viruses and their local transmission,[1] as well as the evolution and spread of these viruses. In order to understand connectedness of the sequences, samples of virus are taken from the infected populations, then viruses are sequenced and analyzed.

SARS-CoV-2 was first detected in December 2019 in people who frequented the Wuhan Huanan market in Guangdong province, China. Based on large-scale sequencing, it was possible to estimate that the epidemic started in November 2019. SARS-CoV-2 is remarkably similar to SARS-CoV-1 in terms of the receptor in humans (ACE2), the animal reservoir (bats), and the fact that both are associated with wet markets.[2] The number of introductions in humans is at present unknown and any intermediate hosts are still also unknown. For SARS-Cov-1 the intermediate hosts were civets and raccoon dogs. Curiously, both viruses were introduced into humans in the month of November, SARS-Cov-1 in 2002, SARS-Cov-2 in 2019. Since 2002, trade and farming of wild animals have decreased in China, so the risk of multiple spillover was reduced. A farm in Hubei was previously found to have animals infected with SARS-CoV-1. Viral sequences determined in animals were very similar to those found in humans infected with SARS-Cov-1. The same farm recently had civets infected with SARS-CoV-2.

Since 1965, nine different coronaviruses have emerged in human population. Coronaviruses are part of Sarbecoviruses, which are widespread in Southeast Asia. Horseshoe bats are also widespread in that region and they are a reservoir of Sarbecoviruses. SARS-CoV-2 spreads easily and, unlike a seasonal influenza, it can infect both upper and lower parts of the respiratory system as well as other organs. High infectivity of many variants of CoV-2 can be attributed to the presence of the receptor binding domain (RBD) and also the presence of a polybasic cleavage site that allows the spike protein to be processed into two subunits and facilitates fast and widespread infection. The SARS-CoV-2 RBD is similar to the RBD of other viruses that infect animals such as bats and pangolins. SARS CoV-2 shows a very high rate of evolution, which in the past two years has resulted in multiple variants.[3] New variants have rapidly displaced the old ones. Omicron, which presumably emerged as a result of immune escape, has an extremely mutated lineage. For example, it has 40 mutations in the spike protein compared to original virus, most of which appears on the outside RBD of the spike protein. The mutations may lead to further optimization of binding to AC2, but also potentially usage of a coreceptor is involved. The spread of omicron is much faster than other variants. This variant is cable of causing new infection and reinfection. Almost entire the human population is susceptible to omicron infection, and SARS-CoV-2 now appears to be endemic.

In summary, SARS-Cov-2 is a fast-evolving virus and several factors such as evolutionary rate, mutational supply, mutational tolerance will determine its further evolution. However, we now have tools to fight the pandemics, including vaccines, anti-viral drugs, rapid tests, masks and better understanding of the virus.

1. Zeller et al. Emergence of an Early SARS-CoV-2 Epidemic in the United States. Cell 184(19):4939-4952, 2021. DOI: 10.1016/j.cell.2021.07.030.

2. Holmes et al. The Origins of SARS-CoV-2: A Critical Review. Cell 184(19):4848-4856, 2021. DOI: 10.1016/j.cell.2021.08.017.

3. Washington et al. Emergence and Rapid Transmission of SARS-CoV-2 B.1.1.7 in the United States. Cell 184(10):2587-2594, 2021. DOI: 10.1016/j.cell.2021.03.052.

The 2022 Science Writing Competition is open!

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Attention Student & Post-doc members:
The 2022 Science Writing Competition is open!

Clear, concise communication is essential to make your science accessible. The Antibody Society is offering you a chance to grow this skill through a Science Writing Competition. For examples, view winning essays from the 2021 Science Writing Competition.

We invite you to submit an essay of 1200 – 1500 words on a topic related to antibody research. Feel free to use an eye-catching self-generated high-resolution graphic (jpg format) to help make your main point. Relevant topics include, but are not limited to:

Antibody engineering
Antibody therapeutics
Fc effector function and neutralization
Bispecific antibodies
Antibody-drug conjugates
Adaptive immune receptor repertoires

The winning essays are featured on The Antibody Society’s website and winners receive a $400 cash prize.

Two winners (1 student, 1 post-doc) will be selected by our panel of judges based on the originality, creativity, clarity, and structure of their essays.

Send your essay to membership@antibodysociety.org as a Word document. The first 30 submissions will be considered for the competition. Please include your contact details and whether you are a student or post-doc in your email.

Submission deadline: May 1, 2022
Essays should be written for a general reader. Guidance on effective scientific writing can be found here and here.

Entry is limited to The Antibody Society student and post-doc members. Additional information can be found here.

Not a member? Membership is free for students and post-docs – register here!

Rare Disease Day, February 28, 2022

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Rare Disease Day is held to raise awareness of the more than 7,000 diseases that each affect a small number of people. In the US, any disease affecting fewer than 200,000 people (1 per ~1,650 people) is considered rare, while in Europe rare diseases ae defined as those that affect fewer than 1 in 2,000 people.

Regulatory agencies in the US, Europe, Japan, as well as other countries, have ‘orphan drug’ programs, which incentivize the development of drugs to treat rare diseases. Numerous monoclonal antibody (mAb) therapeutics have been granted Orphan Drug designations, as illustrated by the examples below.

Recently approved by FDA

Tebentafusp (KIMMTRAK®) for uveal melanoma

Approved by FDA in January 2022, tebentafusp-tebn is a bispecific fusion protein composed of: 1) a T cell receptor (TCR) recognizing a human leukocyte antigen (HLA)-A*02:01 complexed with a peptide derived from gp100 antigen expressed by melanoma cells, and 2) an antibody single-chain variable fragment that binds CD3 present on T cells. Developed by Immunocore, this molecule creates a bridge between tumor cells and immune cells, and thus facilitates tumor-cell killing by T cells. As the TCR domain recognizes a peptide presented on HLA-A*02:01, tebentafusp can only be used to treated patients expressing this HLA type. Tebentafusp was granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA. Tebentafusp is marketed by Immunocore Holdings plc.

Sutimlimab (Enjaymo) for cold agglutinin disease

Sutimlimab-jome, a hinge-stabilized, humanized IgG4k antibody that targets and inhibits complement component 1s (C1s), was approved by FDA in February 2022 as a treatment of hemolysis in adult patients with cold agglutinin disease (CAD). A mutation in the Fc region (L235E) reduces the effector functions of the antibody. This rare autoimmune disorder is characterized by hemolysis caused by activation of the classic complement pathway. Sutimlimab received FDA’s Breakthrough Therapy and Orphan Drug designations for CAD, and Orphan Drug designation in the European Union for this indication. Sutimlimab is marketed by Sanofi.

Biological license applications in FDA review

Spesolimab (Boehringer Ingelheim) for generalized pustular psoriasis

Spesolimab is a humanized IgG1k antibody that blocks activation of the IL-36 receptor, which is involved in the pathogeneses of neutrophilic skin diseases such as generalized pustular psoriasis (GPP), palmoplantar pustulosis and hidradenitis suppurativa. FDA granted spesolimab Orphan Drug designation for the treatment of GPP. Marketing applications are undergoing evaluation by the FDA, as well as the European Medicines Agency (EMA).

Teclistamab (Janssen Research & Development, LLC) for multiple myeloma

Teclistamab (JNJ-64007957) is an IgG4l T-cell redirecting antibody derived from Ligand’s transgenic mouse (OmniAb) and Genmab’s DuoBody technology. The antibody selectively targets BCMA and CD3. Teclistamab was granted Breakthrough Therapy designation for the treatment of relapsed or refractory multiple myeloma (MM) by the FDA, and EMA’s PRIME designation for treatment of adult patients with relapsed or refractory MM who previously received ≥3 prior lines of therapy in 2021. Teclistamab had previously been granted Orphan Drug designations for MM in both the US and EU. Marketing applications are undergoing evaluation by the FDA and EMA.

BLA submission anticipated in Q1 2022

Mirvetuximab soravtansine (ImmunoGen, Inc.) for ovarian cancer   

Mirvetuximab soravtansine (IMGN853), comprising a humanized folate receptor alpha (FRα) IgG1k antibody conjugated to the maytansinoid drug DM4 via a cleavable disulfide linker, is being developed by ImmunoGen as a treatment for epithelial malignancies, including ovarian cancer adenocarcinoma. The drug has been granted US and EU Orphan Drug designations for ovarian cancer, as well as FDA’s Fast Track designation for a specific subset of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. ImmunoGen anticipates submission of a biologics license application in the first quarter of 2022, with potential accelerated approval in 2022.

Keep up to date on the late-stage pipeline and antibody therapeutic approvals all year by visiting our website!

More information about approved antibody therapeutics, including target, format and year of approval, can be found here.

More information about antibody therapeutics in late-stage studies can be found in ‘Antibodies to Watch in 2022‘ and in our searchable online table found here.

FDA issues emergency use authorization for bebtelovimab

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On February 11, 2022, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab (LY-CoV1404), an anti-SARS-CoV-2 monoclonal antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab targets the SARS-CoV-2 spike glycoprotein receptor binding domain. The EUA was issued to Eli Lilly and Co.

The EUA for bebtelovimab is supported by clinical and nonclinical data. The clinical data are from a Phase 2, randomized, single-dose clinical trial (NCT04634409) evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other monoclonal antibodies for treating mild to moderate COVID-19.

Bebtelovimab is authorized 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 progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. A fact sheet for health care providers with additional information about bebtelovimab can be found here.

As previously announced, Lilly signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.