The Antibody Society

the official website of the antibody society

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

Ordspono™ (odronextamab) approved in the European Union

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On August 26, 2024, Regeneron announced that the European Commission approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients.

Odronextamab (REGN1979) is a hinge-stabilized, bispecific human IgG4k antibody targeting CD20 and CD3 with an Fc that was modified to reduce Fc receptor binding. The antibody was derived from Regeneron’s VelocImmune® technology and Veloci-Bi® platform and is being developed for the treatment of RR B-cell NHL. In 2020, Regeneron granted Zai Lab rights to develop and exclusively commercialize odronextamab in oncology in mainland China, Hong Kong, Taiwan, and Macau. Odronextamab received Fast Track designation from FDA and Orphan Drug designations by the FDA and EMA for the treatment of patients with FL and DLBCL, which are subtypes of NHL.

The approval in the European Union is based on results from the Phase 1 ELM-1 (NCT02290951)  and pivotal Phase 2 ELM-2 (NCT03888105) trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL

  • Results from ELM-1 (N=60) in R/R DLBCL patients who had progressed after CAR-T therapy, as assessed by an independent review committee (IRC) showed 48% objective response rate (ORR), with 32% achieving a complete response (CR). Among responders (n=29), the median duration of response (DoR) was 15 months (95% CI: 3 months to not estimable (NE)).
  • Results from ELM-2 (N=127) in R/R DLBCL patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR. Among complete responders the median DoR was 18 months (95% CI: 10 months to NE).
  • In R/R FL, results from ELM-2 (N=128) as assessed by an IRC showed an objective response rate (ORR) of 80%, with 73% achieving a CR. Among complete responders, the median DoR was 25 months (95% confidence interval [CI]: 20 months to NE).

Regeneron submitted biologics license applications (BLAs) for odronextamab for RR FL and DLBCL to FDA. In March 2024, Regeneron announced that the FDA issued complete response letters for the Biologics License Applications for odronextamab. The company noted that FDA’s only approvability issue is related to the enrollment status of the confirmatory trials.

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Announcing Leadership Changes and New Opportunities at The Antibody Society.

We are pleased to announce that Dr. Janice Reichert, who has served as our Chief Operating Officer, will be transitioning to a new role as Director of Business Intelligence. Janice’s leadership has been crucial to our success, and we are confident that she will continue to drive our mission forward in this new capacity.

Dr. Janice Reichert is an internationally recognized expert in the development of antibody therapeutics. She has been affiliated with The Antibody Society since 2010, serving on the Society’s Board of Directors and various committees, including as Executive Director and most recently as Chief Operating Officer. She is now transitioning to the role of Director of Business Intelligence.

Dr. Reichert created mAbs, a peer-reviewed, PubMed-indexed biomedical journal focusing on antibody research and development and has served as Editor-in-Chief since its inaugural publication in 2009. She has published extensively on development trends for antibody therapeutics and is particularly well known for creating the annual “Antibodies to Watch” articles, which have collectively been viewed nearly 290,000 times. Dr. Reichert has also presented her research at conferences worldwide. She received her Ph.D. in Chemistry from the University of Pennsylvania and completed her post-doctoral training at Harvard Medical School.

We wish Janice all the best in her new role!

Join Our Growing Team!

As we continue to expand, we are seeking a talented and experienced Business Manager to oversee all aspects of our organization’s financial and operational functions. If you have a strong background in business management and are passionate about joining our mission to enhance knowledge and understanding through information sharing and collaboration in the field of antibody research and development, we encourage you to apply.

Please send your resume to jobs@antibodysociety.org

For more information about the role, please refer to the detailed job description provided below.

Looking Ahead.

We will be announcing additional new roles in the coming months. Be sure to watch this space for more opportunities to join our team.

Thank you for being a part of our community!

https://www.antibodysociety.org/the-antibody-society-org-news/18648/

AIRR-C Meeting VII: A Landmark in AIRR Research!

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The AIRR-C VII Meeting, held from June 3-6, 2024, at the Faculty of Engineering, University of Porto, Portugal, was a triumph, highlighting the latest in AIRR research. We delved into “Fundamental Immunological Processes and Human Diseases” through dedicated and groundbreaking discussions. Challenge sessions included Germline Gene Diversity where we explored interindividual variability in AIRRs with major implications for disease and vaccine prediction and Machine Learning Approaches which showcased AIRRs’ potential in predicting disease outcomes and discovering new therapeutic targets. 

Key Highlights

The success of AIRR-C VII was bolstered by the generous support of our 19 sponsors and partners, whose contributions were instrumental. We extend our heartfelt thanks to all who supported us. The event drew a diverse global audience with 182 in-person attendees and 31 remote participants from 26 countries, marking an increase from 2022. Our exceptional program featured 16 invited speakers, 10 contributed talks, 96 research posters, 11 Working Group and Sub-Committee posters, and a dynamic mix of sessions including 10 lightning demos and 9 deep dive tutorials. Participants engaged in hands-on, one-hour “deep dive” tutorials and short 10-minute “lightning” demonstrations of innovative software and tools, enhancing their technical skills and knowledge.

Early career researchers and students actively participated in career development activities alongside the scientific program. “Networking is in the AIRR” featured a speed networking event connecting early career scientists with established AIRR researchers, fostering invaluable connections across sectors and research areas. A career development panel discussion offered insights into diverse career paths within AIRR research, complementing the scientific sessions and providing opportunities for direct engagement with experts.

As part of the Industry Networking Reception, a special “hot topics in the field” round table session provided a unique opportunity for industry partners and scientific researchers to engage in exciting discussions. Moderated by pairs of AIRR-C Working Group Co-leaders and Industry Partners, these sessions focused on future needs and challenges in key areas such as “Antibody Discovery,” “AIRR-seq epitope/antigen annotation,” “Datasets and applications/tools for mining the repertoire,” “Biological Standards/Controls/Methods,” and “Data sharing & data standards for AIRR analysis and software.” The goal of these discussions was to gather input and ideas to shape the future of AIRR research.

Looking Ahead

AIRR-C VII has set a new standard for excellence. We eagerly anticipate the AIRR-C VIII meeting in 2026, where we will continue driving the exciting advancements in immunogenetics.

For more information, visit [Event Website] or contact us at [Contact Information] or follow us at #AIRRC8.

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