The Antibody Society

the official website of the antibody society

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

FDA approves Kisunla™ (donanemab-azbt) for Alzheimer’s disease

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On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) for adults with early symptomatic Alzheimer’s disease (AD) and people with the mild dementia stage of AD, with confirmed amyloid pathology. Donanemab (LY3002813) is a humanized IgG1k monoclonal antibody that targets Ab(p3-42), a pyroglutamate form of amyloid beta that is aggregated in amyloid plaques. Donanemab was granted Breakthrough Therapy designation by FDA for the treatment of AD.

FDA’s approval was based in part on results from the TRAILBLAZER-ALZ 2 Phase 3 study in which 1736 patients with early symptomatic AD with amyloid and low/medium or high tau pathology were randomized 1:1 to receive IV donanemab (n=860) or placebo (n=874) Q4W for 72 weeks. [1] Trial participants were analyzed over 18 months in two groupings: one group who was less advanced in their disease (those with low to medium levels of tau protein) and the overall population. Treatment with Kisunla significantly slowed clinical decline in both groups, with people who were the least advanced in the disease experiencing the strongest results with Kisunla.

  1. Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, Wessels AM, Shcherbinin S, Wang H, Monkul Nery ES, et al. Donanemab in early symptomatic Alzheimer disease: The TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. doi: 10.1001/jama.2023.13239.

Monday, June 3rd is the Big Day!

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AIRR-C Meeting VII – Learnings and Perspectives is starting this Monday, June 3rd, at the Faculty of Engineering, University of Porto, in Porto, Portugal. This meeting is the regular main event of the AIRR Community and allows participants (both in-person and virtual)to enjoy a variety of scientific presentations, discussions, and poster sessions to stay up-to-date with the most recent developments in the field. It is also a great opportunity to engage with colleagues and industry sponsors, and to help early career researchers such as graduate students and post-docs learn more about possible opportunities. A huge thank you to all our sponsors who make this event possible. Your support is invaluable and greatly appreciated!

Check out the full agenda and more details on the meeting page: https://tinyurl.com/airrcmeeting7.

Use the hashtag #AIRRC7 in social media to follow and share content about AIRR-C Meeting VII.

AIRR Community Meeting VII 2024 Sponsors Infographic

Congratulations to the winners of the 2024 Science Writing Competition!

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The Antibody Society offers our student and post-doc members a chance to grow their writing skills through a Science Writing Competition. This competition is organized and managed by the Society’s Communication & Membership Committee.

Entrants submitted essays of 1200 – 1500 words on a topic related to antibody research that were evaluated by our panel of judges based on: originality, structure of the essay, and presentation (clarity and creativity).

University student winner:
Igor García Atutxa (Universidad Católica San Antonio de Murcia, Murcia, Spain)

Essay title: “Dark Times in Microscopic Earth: The Immunological Epic Against the Dark Forces of Infection”

 
 

Secondary school student winner:
William Levy (Seabury Hall College Prep School, Maui, HI, USA)

Essay title: “Including Antibodies in Cancer Treatment”

 

 

Congratulations to the winners and thanks to everyone who participated! 

The next Science Writing Competition opens in March 2025.

Improve your BCR sequencing analysis with refined IG reference germline sets

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An important aspect of the adaptive immune receptor repertoire analysis is the identification of the V, D, and J genes contributing to the rearranged sequences. Often, the identification of the specific genes requires the use of a reference set of known immune receptor allelic germline variants. Since early meetings of the Adaptive Immune Receptor Repertoire Community (AIRR-C), members of the community have expressed the need to have access to germline sets open to everybody (including industry) that didn’t present known issues in the available germline sets such as different nomenclatures and the requirement of buying licenses. In February 2024, the Germline Database Working Group (GLDB WG) published the manuscript “AIRR-C IG Reference Sets: curated sets of immunoglobulin heavy and light chain germline genes” introducing the AIRR-C human immunoglobulin germline gene reference. This reference is available for download at OGRDB and also available for use in IgBLAST. The AIRR-C IG Reference Sets follow the FAIR principles (Findable, Accessible, Interoperable, and Reusable) and require a minimally restricted licence.

In episode 15 of the On AIRR podcast, Dr. William Lees (researcher at University of London and co-leader of the GLDB WG) and Dr. Corey Watson (associate professor at the University of Louisville) explain in detail the context and expectations of this effort, a major achievement of the group. Watson highlights the impressive effort that it has been for the community to get on the same page, and reach a consensus that could be materialized in these new reference sets, all during a time where the field has matured and evolved in multiple levels. “It has taken us a lot to think how to build a system that is able to accommodate all the elements and also be responsive to changes in the future. We have established a foundation that we can use to build on top of”, Watson says. Good traceability and reproducibility were also requirements from the community. In that sense, Lees explains that “the sets are free to use, can be downloaded through a REST API, they also have a DOI number, so every time a set changes, we create a new DOI, so it is a good reference to put in a paper”.

If you want to learn about the recent innovations and challenges in the generation, curation and analysis of antibody/B-cell and T-cell receptor repertoire data, and in particular in the development and use of germline resources, don’t miss the “AIRR-C Challenge Session: Using IG and TR germline resources for advancing immunobiology” in the upcoming hybrid “AIRR Community Meeting VII – Learnings and Perspectives”.

FDA approves IMDELLTRA™ (tarlatamab-dlle) for extensive-stage small cell lung cancer

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On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted an accelerated approval for IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval was based on surrogate endpoints, including response rate and duration of response observed in clinical studies, and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMDELLTRA is bispecific T cell engager (BiTE®, (scFv)2-scFc)) antibody that targets DLL3 on tumor cells and CD3 on the patient’s T cells and has mutations in the Fc (N297G; R292C, V302C) to extend the half-life of the molecules.

FDA’s accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial (NCT05060016) that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. As reported in the New England Journal of Medicine, results from the study found that IMDELLTRA at the 10 mg Q2W dose demonstrated an objective response rate of 40% and median progression-free survival of 4.9 months. treatment-related adverse events that caused patients discontinuation of tarlatamab treatment occurred in a low percentage (3%) of patients.

IMDELLTRA is currently being evaluated in two Phase 3 studies of SCLC. The Phase 3 DeLLphi-304 study (NCT05740566) is evaluating tarlatamab compared with standard of care in subjects with relapsed SCLC after platinum-based first-line chemotherapy. The Phase 3 DeLLphi-306 study (NCT06117774) is evaluating tarlatamab in subjects with limited-stage SCLC who have not progressed following concurrent chemoradiation therapy. A third Phase 3 study, DeLLphi-305 (NCT06211036), evaluating tarlatamab in combination with durvalumab vs durvalumab alone in subjects with ES-SCLC following platinum, etoposide and durvalumab was not yet recruiting patients as of the last update posted on May 10, 2024.

Details for all approved antibody therapeutics are found in our searchable online table.