The Antibody Society

the official website of the antibody society

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

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Welcoming Esther Kang as Our New Business Manager at The Antibody Society!

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Esther is a bilingual professional with a strong background in project management, strategic communications, and cross-functional collaboration, with extensive experience working in diverse international environments. Fluent in English and Korean, she specializes in supporting global initiatives, particularly in the areas of education, non-profit management, and most recently at an EV battery start up. Esther has worked with organizations such as Ultium Cells and Jeonbuk National University, where she successfully led cross-departmental projects, facilitated partner relations, and developed training programs.

As the Business Manager at the Antibody Society, Esther will be responsible for overseeing the Society’s operational functions, ensuring the successful execution of TAbS’ business plan, and managing key office systems and procedures. Esther is excited to bring her experience in integrating diverse workforces and advancing organizational objectives to help the Antibody Society further its mission and foster global collaboration within the antibody research community. In her spare time, she is an avid hiker, aspiring plant mom, and food enthusiast.

We wish her the very best as she embarks on this new chapter in her career!

Welcoming Kristen McPike to the TAbS team!

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We are very pleased to announce that Kristen McPike has joined us as a Program and Alliance Manager.

Kristen has a Bachelors of Science in Biology from Loyola University Chicago and a Masters of Science in Anatomy from Howard University College of Medicine. Kristen is passionate about communicating about science and medicine. She loves using the skills she developed throughout her education and during her previous role as a Project Manager with AstraZeneca’s Lung Immuno-oncology (IO) Team to help teams and organizations work more efficiently. In addition to this, Kristen co-founded a 501c3 called Black in Anatomy and runs her own tutoring business where she’s supported over 100 students in STEM related coursework. In her spare time, Kristen loves biking, swimming, hiking, fostering cats, and traveling the world with her fiancee. We wish Kristen all the best in her new role!

New episode of our Antibody News podcast is now available!

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Antibody News is the 10-minute news podcast of The Antibody Society.

In this episode, we cover new business news, advancements in the clinical pipeline, and important regulatory updates, including new marketing applications and marketing approvals from September 15 – October 1, 2024.

Listen for FREE on:

PodBean –> https://lnkd.in/eqchSdT7
Spotify –> https://lnkd.in/e_5BeucT
Apple Podcasts –> https://lnkd.in/ec9S6HJp
Amazon Music –> https://lnkd.in/es5Dz3hW
Audible –> https://lnkd.in/einBGchf

First approval for teprotumumab-trbw (Tepezza)

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On January 21, 2020, the U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, which is associated with an outward bulging of the eye that can cause eye pain, double vision, light sensitivity or difficulty closing the eye. Teprotumumab, a human IgG1 antibody targeting insulin growth factor 1 receptor, was granted Fast Track, Breakthrough Therapy and Orphan Drug designations by the FDA. Positive data from both Phase 2 (NCT01868997) and Phase 3 (OPTIC, NCT03298867) studies were reported by Horizon Pharma. In the randomized, placebo-controlled OPTIC study, teprotumumab met the study’s primary endpoint, which was a responder rate of ≥ 2 mm reduction of proptosis (bulging) in the study eye (without deterioration in the fellow eye) at Week 24. Data from the OPTIC study showed that 82.9% of patients receiving teprotumumab were proptosis responders compared to 9.5% of patients receiving placebo at Week 24 (p<0.001). All secondary endpoints in the study were also met.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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“Antibodies to Watch in 2020” is now online!

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This 2020 installment of the annual ‘Antibodies to Watch’ series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*.  At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry’s clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.

*Note on key updates through December 20, 2019: 1) the US Food and Drug Administration granted accelerated approval to [fam-]trastuzumab deruxtecan (Enhertu) on December 20, 2019; 2) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 7; 3) the European Commission approved romosozumab on December 9, 2019; 4) the European Medicines Agency issued a positive opinion for brolucizumab; 5) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 6) GlaxoSmithKline submitted a BLA for belantamab mafodotin; 7) Macrogenics submitted a BLA for margetuximab; and 8) the status of the Phase 3 study (NCT04128696) of GSK3359609 in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.