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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!

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.

FDA approves Enjaymo (sutimlimab-jome) for cold agglutinin disease

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On February 4, 2022, the US Food and Drug Administration (FDA) approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). This rare autoimmune disorder is characterized by hemolysis caused by activation of the classic complement pathway. Sponsored by Sanofi, sutimlimab is a hinge-stabilized, humanized IgG4k antibody that targets and inhibits complement component 1s (C1s). A mutation in the Fc region (L235E) reduces the effector functions of the antibody. Sutimlimab received FDA’s Breakthrough Therapy and Orphan Drug designations for CAD, and Orphan Drug designation in the EU for this indication.

The BLA was based on data from the CARDINAL open-label, single-arm study (NCT03347396), which enrolled 24 adult patients with CAD who received a recent blood transfusion. All participants received Enjaymo for up to six months and could choose to continue therapy in a second part of the trial. Based on body weight, participants received either a 6.5 g or 7.5 g infusion of Enjaymo on day 0, day 7, and every 14 days through week 25. In total, 54% of participants responded to Enjaymo. In this study, sutimlimab administration rapidly halted hemolysis, increased hemoglobin levels, and reduced fatigue.

The European Medicines Agency has accepted the submission of a Marketing Authorisation Application for sutimlimab.

Enjaymo is the 3rd antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

FDA approves Vabysmo™ (faricimab-svoa) for ophthalmic disorders

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On January 28, 2022, Genentech announced that the U.S. Food and Drug Administration has approved Vabysmo ™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Faricimab (RO6867461, RG7716) is an anti-vascular endothelial growth factor-A (VEGF-A) and anti-angiopoietin-2 (Ang-2) bispecific antibody derived from Roche’s CrossMab technology.

The approval was based in part on results from four Phase 3 studies in wet AMD and DME. The randomized, double-masked, and active comparator-controlled TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies evaluated the effects of faricimab (6.0 mg administered at fixed intervals of every two, three, or four months) and aflibercept (Eylea®) (2.0 mg administered at fixed two-month intervals) in wet AMD patients. The primary endpoint of the studies, average change in best-corrected visual acuity (BCVA) from baseline through week 48, was met in both studies. The average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, compared to +5.1 and +6.6 letters in the aflibercept arms, in the TENAYA and LUCERNE studies, respectively, demonstrating the non-inferiority of faricimab compared to aflibercept. The study also showed that faricimab’s treatment interval could be longer than that of aflibercept – nearly 80% of patients treated with faricimab were able to go three months or longer between treatments during the first year.

The 3-arm, randomized, double-masked, active comparator-controlled YOSEMITE (NCT03622580) and RHINE studies (NCT03622593) compared the effects of faricimab (6.0 mg administered at personalized treatment intervals (PTI) of up to four months or 6.0 mg administered at fixed two-month intervals) to those of aflibercept (2.0 mg administered at fixed two-month intervals) in DME patients. The primary endpoint, average change in BCVA score from baseline at one year, was met, with faricimab again showing non-inferiority in visual acuity gains compared to aflibercept. In the YOSEMITE study, the average vision gains from baseline were +11.6, +10.7, and +10.9 letters eye chart letters in the faricimab PTI, faricimab two-month, and aflibercept arms, respectively. The average vision gains from baseline were +10.8, +11.8, and +10.3 letters in the faricimab PTI, faricimab two-month, and aflibercept arms, respectively, in the RHINE study.

Further details for the TENAYA and LUCERNE and YOSEMITE and RHINE studies were published in The Lancet.

The European Medicines Agency has accepted the submission of a Marketing Authorisation Application for faricimab.

Vabysmo ™ is the 2nd antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

Register now for our webinar on computational mining of immune receptor germline gene loci variation

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Registration for our next webinar, “Computational mining of immune receptor germline gene loci variation“, is now open!

B and T cell receptors play a critical role in responding to pathogens and vaccination, and in the pathology of several diseases of the immune system. Gene segments at the T cell receptor and immunoglobulin loci serve as templates for the generation and expression of T and B cell receptors and antibodies. Defining genetic variation within these highly polymorphic loci is critical to furthering our understanding of immunological diseases, and informing the design of vaccines and therapeutics. However, at the genomic level, these loci have been difficult to analyze due to their repetitive nature, rich in segmental duplications, simple repeats and retrotransposon elements. To overcome this complexity, several sequencing technologies and algorithms have been developed to more fully define the spectrum of genetic variation in these immune loci in human populations and other species. This webinar includes demonstrations of three orthogonal and complementary methods. First, Dr. Corcoran will present IgDiscover, an IG and TR adaptive immune repertoire sequencing (AIRR-seq) germline inference tool that has been in use for several years and applied to multiple species. The IgDiscover output is highly reproducible and can facilitate the comparison of multiple individuals in disease cohorts to identify disease associated allelic or structural variants. Ayelet Peres will present on VDJbase and RAbHIT, two bioinformatics tools for germline variation detection from AIRR-seq using population analysis and chromosomal phasing. These tools have been used to discover germline variations affecting the expressed repertoires. Finally, Dr. Rodriguez will demonstrate an approach using long-read sequencing and a bioinformatics tool, IGenotyper, to fully characterize both coding and non-coding single-nucleotide variants, small insertions and deletions, and structural variants across IG and TCR loci in a haplotype-specific manner. This will also include discussion on how IGenotyper is being applied to survey immune loci in non-human species.

Register here!

Tools and Software to be discussed:

  • IgDiscover analyzes antibody repertoires and discovers new V genes from high-throughput sequencing reads. Heavy chains, kappa and lambda light chains are supported (to discover VH, VK and VL genes).
  • VDJbase.org – a database of adaptive immune receptor genes, genotypes, and haplotypes.
  • RAbHIT – R tool for haplotype inference from BCR and TCR repertoires.
  • VDJbase pipeline –  BCR and TCR repertoires downstream analysis for VDJbase reports.
  • IGenotyper (or IG) was developed for PacBio capture data to assemble the Immunoglobulin Heavy Chain locus (IGH), genotype the IGH genes, and identify SNPs, indels and SVs within the IGH locus.