The Antibody Society

the official website of the antibody society

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

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!

“Antibodies to Watch in 2025” is now online!

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Read all about Antibodies to Watch in 2025 here.

From the abstract:

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (依達方®), and antibody–drug conjugate (ADC) sacituzumab tirumotecan (佳泰萊®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

“Antibodies to Watch” is an article series started in 2010. All articles are published in mAbs. The series Collection can be accessed here.

 

Greetings, antibody enthusiasts and AE&T 2024 attendees!

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As an international non-profit supporting antibody related research and development, we invite you to explore our extensive resources and the latest insights in the field.

Learn more about what we offer:

Whether you’re a long-time member or a first-time visitor, there’s something here for everyone passionate about antibody research and development.

Attending AE&T 2024?

We’re happy to be a proud scientific program partner at AE&T 2024 in San Diego from December 15-18! If you’re around, we’d love to connect with you at our booth (#113). Stop by to grab a goodie and learn more about the latest in Antibody Engineering and Therapeutics.

If you’re in or around the San Diego area and are a member of The Antibody Society, don’t forget that TAbS members receive a 15% discount on registration for all AE&T meetings! For more information about AE&T San Diego 2024, visit: https://informaconnect.com/antibody-engineering-therapeutics/ we look forward to seeing you there!

Not a member yet?

If you’re an employee of one of our corporate sponsors, you can sign up for free and gain access to all the exclusive resources and benefits available to our members. If you’re not an employee of a corporate sponsor and are interested in getting involved, explore our membership levels and sign up today to become part of a global community dedicated to advancing antibody science.

Happy Holidays!

FDA approves BIZENGRI® (zenocutuzumab-zbco)

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On December 4, 2024, Merus N.V. announced the FDA approved BIZENGRI® (zenocutuzumab-zbco) as a treatment indicated for adults with pancreatic adenocarcinoma or NSCLC that are advanced unresectable or metastatic and harbor a NRG1 gene fusion who have disease progression on or after prior systemic therapy.

Zenocutuzumab is a humanized, ADCC-enhanced, bispecific IgG1k antibody that simultaneously targets the growth factor receptors HER2 and HER3, thereby blocking signal transduction caused by the binding of HER3 with its ligand neuregulin 1 (NRG1) or NRG1-fusion proteins. The antibody is in development by Merus as a treatment for patients with solid tumors harboring NRG1 gene fusions (NRG1+ cancer), who typically have suboptimal responses to conventional systemic treatment. FDA granted Breakthrough Therapy Designation for zenocutuzumab for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options, as well as Fast Track Designation for the treatment of patients with metastatic NRG1+ cancer that have progressed on standard of care therapy and Orphan Drug Designation for the treatment of patients with pancreatic cancer.

FDA’s approval was based on data from the open-label Phase 1/2 eNRGy trial (NCT02912949), which evaluated the safety and anti-tumor activity of zenocutuzumab monotherapy in NRG1+ NSCLC, PDAC, and other solid tumors. The study consisted of three patient cohorts: 1) NRG1+ NSCLC, 2) NRG1+ PDAC, and 3) other NRG1+ solid tumors. In the dose expansion period of the eNRGy study, participants received IV infusions of 750 mg of zenocutuzumab Q2W. Response rates were measured using RECIST v1.1 as assessed by blinded ICR. The ORR was 33% (95% CI, 22%-46%) and 40% (95% CI, 23%-59%) in the NRG1+ NSCLC (n=64) and NRG1+ PDAC (n=30) cohorts, respectively, and the median DOR was 7.4 months (95% CI, 4.0-16.6) in the NRG1+ NSCLC cohort and ranged from 3.7 months to 16.6 months in the NRG1+ PDAC cohorts.

Curious about what other antibody therapeutics are approved or in regulatory review? Our online table contains details for over 200 such antibodies! 

FDA approves zanidatamab (Ziihera®)

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On November 20, 2024, Jazz Pharmaceuticals announced that FDA granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.[28] A confirmatory, randomized Phase 3 trial (HERIZON-BTC-302; NCT06282575) evaluating zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC initiated in July 2024 is currently recruiting patients.

Zanidatamab (ZW25) is a humanized, biparatopic, bispecific IgG assembled from half-antibodies (Fab-h-CH2-CH3 x scFv-h-CH2-CH3) that targets two non-overlapping epitopes of HER2. In 2022, Zymeworks licensed the development and commercialization rights across all indications in the United States, Europe, Japan and all other territories, except for those Asia/Pacific territories previously licensed by Zymeworks, to Jazz Pharmaceuticals. BeiGene acquired exclusive development and commercial rights to zanidatamab, in Asia (excluding Japan), Australia, and New Zealand in 2018. FDA granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified BTC, Fast Track designation for zanidatamab as a single agent for refractory BTC, and Orphan Drug designation for zanidatamab in refractory BTC.

The approval was based in part on the results of the single-arm, Phase 2b trial (HERIZON-BTC-01; NCT04466891) of zanidatamab in patients with HER2-amplified, unresectable, locally advanced, or metastatic BTC with disease progression on previous gemcitabine-based therapy. The efficacy of zanidatamab was evaluated in 62 patients with HER2-positive (IHC 3+ by central assessment) BTC in Cohort 1 of HERIZON-BTC-01, with major efficacy outcome measures of  objective response rate (ORR) and duration of response (DOR) as determined by independent central review according to RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. The study demonstrated an ORR of 52% [95% confidence interval (CI): 39, 65)] with a Kaplan Meier estimated median DOR of 14.9 months [95% CI: 7.4-not estimable] by independent central review [1].

Marketing applications for zanidatamab as a treatment for BTC were also submitted in the European Union and China. Beigene anticipates approval by NMPA for zanidatamab as second-line treatment of HER2+ BTC in the second half of 2025.

[1] ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.