The Antibody Society

the official website of the antibody society

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

Reconnect with the AIRR Data Commons: Your Gateway to Immunology Discoveries

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The AIRR Community continues to spearhead innovation in immunology research with the ever-expanding AIRR Data Commons (ADC). For those unfamiliar, the ADC is a pioneering initiative that enables the sharing of standardized Adaptive Immune Receptor Repertoire (AIRR) data. This resource hosts a wealth of information about the diverse array of antibody/B-cell and T-cell receptors that govern immune responses, obtained from bulk and single-cell sequencing technologies. By facilitating the exchange of this valuable data, the ADC enables researchers to gain deeper insights into immunity, disease progression, and therapeutic interventions.

From its inception in 2018 with under 400 million sequence annotations, the ADC has expanded into nine distributed repositories housing 89 studies, over 9800 sample repertoires, and an astonishing 5.2 billion sequence annotations. But this growth is not just about numbers – it’s about fostering collaboration and igniting discoveries. Scientists around the world can access a unified platform to discover, compare, and analyze immunological data, transcending the limitations of individual labs. This interconnectedness not only drives innovation but also eliminates redundancy, saving precious time and resources.

As we look to the future, the ADC is poised to play an even more pivotal role. Its flexible, collaborative framework and continued growth in data will likely attract interdisciplinary partnerships that foster a holistic understanding of the immune system’s complexities. Moreover, the integration of technologies such as machine learning and AI promise to extract deeper insights from the wealth of data, unraveling intricate mechanisms of the immune response.

The AIRR Community’s effort to build and maintain the ADC transcends geographical boundaries and institutional affiliations, exemplifying the spirit of scientific inquiry. As we celebrate the achievements thus far, we eagerly anticipate the advancements that this collaborative endeavor will bring to immunology research in the years to come.

The ADC can be searched interactively using a web user interface at the iReceptor Gateway or VDJServer Community Data Portal. To contribute to the ADC, consider setting up a local repository via the iReceptor Turnkey or submitting data through the VDJServer Community Data Portal.

September Seminar Series

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The September AIRR-C seminar is fast approaching! On September 28th at 7:00 PST/10:00 EST/16:00 CET, Pieter Meysman of the University of Antwerp will be discussing the applications of TCR-epitope prediction models and Felix Drost of Helmholtz Munich will be discussing the prediction of T cell receptor functionality against mutant epitopes.

Register now! The seminar will last approximately 90 minutes.

Register for the AIRR Community Special Event 2023 – Zooming in to the Community II

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Delve into the latest developments and clinical applications of adaptive immune receptor repertoire (AIRR) sequencing in this mid-cycle virtual event, on September 20 and 21, 2023.

What to Expect:

Community Updates: The event will kick off on September 20th with updates and discussions from AIRR Community Working Groups and Sub-committees. You’ll hear about the latest achievements and challenges from members of Biological Resources, Common Repository, Diagnostics, Germline Database, Legal and Ethics, Software, Standards, and more.

Strategic Planning: Dive deeper into the strategic planning session, where the AIRR-C’s Strategic Planning Sub-committee will present selected challenges and invite attendees to brainstorm strategies to address them. This session will focus on achieving recognition of the AIRR-C by the scientific community and adoption of AIRR-C standards, tools, and protocols.

Clinical Applications: On September 21st, the event will pivot to a special Diagnostics Session entitled “Bringing AIRR-seq to the clinic – mapping the challenges.” Explore the regulatory landscape for AIRR-seq-based products in clinical settings, including disease monitoring and diagnostics. 

Panel Discussion: Engage with the speakers during a panel discussion moderated by Dr. Enkelejda Miho, highlighting different aspects of regulatory pathways, with a focus on software as a medical device.

Why Attend:

This event provides a unique opportunity to connect with leading experts, researchers, and professionals in the field of immunology. Whether you’re involved in research, diagnostics, or data management, this AIRR Community Special Event 2023 offers a platform to explore the latest advancements, discuss challenges, and help shape the future of AIRR sequencing.

Event Details:

  • Date: September 20 & 21, 2023
  • Time: 7:00 – 10:00 PDT / 16:00 – 19:00 CEST
  • Location: Online
  • The event is free, but you must register to attend.

For more information, visit the event website.

FDA approves Veopoz (pozelimab-bbfg) for CHAPLE disease

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On August 18, 2023, the US Food and Drug Administration (FDA) approved Veopoz (pozelimab-bbfg) injection for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. Pozelimab (REGN3918) is a human IgG4k antibody targeting complement component 5 (C5) developed by Regeneron. Veopoz received fast track, orphan drug, and rare pediatric disease designations.

Veopoz is the first FDA-approved treatment for CHAPLE disease. An initial dose of 30 m/kg Veopoz is administered intravenously (IV), followed by weekly injections of 10 m/kg given subcutaneously by a health care provider. See the prescribing information for details

The efficacy and safety study of pozelimab in patients with CHAPLE were evaluated in an open-label, single arm Phase 2/3 study (NCT04209634). The study included 10 patients from 3 to 19 years of age with a clinical diagnosis of CD55-deficient PLE disease who received a single loading IV dose on Day 1, then fixed SC doses based on body weight every week over the treatment period. The primary outcome measure of the study was the proportion of patients with active disease at baseline achieving both normalization of serum albumin and clinical outcome improvement. All 10 patients achieved a serum albumin concentration of at least 3.5 g/dL by week 12, which was maintained through at least 72 weeks. All 10 patients also demonstrated a reduction in the number of hospitalizations and number of albumin transfusions over the first 48 weeks of treatment as compared to the 48 weeks prior to treatment.

Interested in data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.

Elranatamab-bcmm (Elrexfio) approved for multiple myeloma

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On August 14, 2023, the Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.) for adults with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The biologics license application (BLA) for elranatamab was granted priority review, breakthrough designation and orphan drug designation by FDA.

Elranatamab (PF-06863135) is a humanized IgG2a T cell-engaging bispecific antibody designed to target BCMA, which is highly expressed on tumor cells, and CD3 found on the T cell surface. Developed by Pfizer, elranatamab is formulated for subcutaneous, rather than intravenous, administration. The recommended elranatamab-bcmm dosages include the following: “step-up dose 1” of 12 mg on Day 1, “step-up dose 2” of 32 mg on Day 4, followed by the first treatment dose of 76 mg on Day 8, and then 76 mg weekly, thereafter, through week 24.

The prescribing information for elranatamab-bcmm includes a Boxed Warning for life threatening or fatal cytokine release syndrome and neurologic toxicity. Elrexfio is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the ELREXFIO REMS.

Elranatamab’s efficacy was evaluated in MagnetisMM-3 (NCT04649359), a Phase 2, open-label, single-arm, multi-center study that included patients with r/r MM who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody. Patients had measurable disease by International Myeloma Working Group (IMWG) criteria at enrollment. The main efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), as assessed by a blinded independent central review based on IMWG criteria. The primary efficacy population consisted of 97 patients naïve to prior BCMA-directed therapy and who had previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The ORR in the 97 patients receiving the recommended dose was 57.7% (95% CI: 47.3%, 67.7%). With a median follow-up of 11.1 months among responders, the median DOR was not reached (95% CI: 12 months, not reached). The DOR rate at 6 months was 90.4% (95% CI: 78.4%, 95.9%) and at 9 months was 82.3% (95% CI: 67.1%, 90.9%).

FDA’s BLA review was conducted under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. The Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Swissmedic collaborated with FDA in the review process, and are continuing to review marketing applications for elranatamab.

Interested in data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.