The Antibody Society

the official website of the antibody society

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FDA approves antibody-drug conjugate Datroway

January 21, 2025 by Janice Reichert

On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The recommended datopotamab deruxtecan-dlnk dose is 6 mg/kg (maximum of 540 mg for patients ≥90 kg), administered as an intravenous infusion, once every 3 weeks (21-day cycle), until disease progression or unacceptable toxicity.

Datopotamab deruxtecan is an anti- trophoblast cell-surface antigen 2 (TROP2) ADC in development as a treatment for breast and lung cancer. The payload, a topoisomerase I inhibitor, is conjugated to a humanized IgG1k antibody via a cleavable linker. Daiichi Sankyo maintains exclusive rights for this ADC in Japan but has an agreement with AstraZeneca to jointly develop and commercialize datopotamab deruxtecan in the rest of the world. DATROWAY® was first approved in December 2024 in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.

Efficacy was evaluated in TROPION-Breast01 (NCT05104866), a multicenter, open-label, randomized trial.  A total of 732 patients were randomized (1:1) to datopotamab deruxtecan (n=365) or investigator’s choice of chemotherapy (n=367); eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%). The major efficacy outcome measures were progression-free survival (PFS), assessed by blinded independent central review (BICR), based on RECIST v1.1 and overall survival (OS). Additional efficacy outcomes included confirmed objective response rate (ORR) and duration of response (DOR) by BICR. Median PFS was 6.9 months (95% CI: 5.7, 7.4) in the datopotamab deruxtecan-dlnk arm and 4.9 months (95% CI: 4.2, 5.5) in the chemotherapy arm (Hazard ratio 0.63 [95% CI: 0.52, 0.76] two-sided p-value <0.0001). Median OS was 18.6 months (95% CI: 17.3, 20.1) in the datopotamab deruxtecan-dlnk arm and 18.3 months (95% CI: 17.3, 20.5) in the chemotherapy arm (Hazard ratio 1.01 [95% CI: 0.83, 1.22]; two-sided p-value was not statistically significant). Confirmed ORR was 36% (95% CI: 31, 42) and 23% (95% CI: 19, 28) and median DOR was 6.7 months (95% CI: 5.6, 9.8) and 5.7 months (95% CI: 4.9, 6.8) in the datopotamab deruxtecan-dlnk and chemotherapy arms, respectively.

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

Filed Under: Approvals, Food and Drug Administration Tagged With: antibody therapeutics, approved antibodies, Food and Drug Administration

Register now for the Jan 30th AIRR Community Seminar Series

January 20, 2025 by Lorissa Corrie

Register now for the January 30th AIRR Community Seminar Series

Registration for the January 30th (4:00 PM – 5:30 PM CET) AIRR-C Seminar Series session is open. Following the usual format of the series, an established and an early career scientist will discuss their AIRR-seq related research.

Mikhail Pogorelyy of St. Jude Children’s Research Hospital, USA will present “TIRTL-seq: Deep, quantitative, and affordable paired TCR repertoire sequencing.” Next, Eglantine Hector of the Marseille Immunology Center, France will present “SeQuoIA: a pipeline for inference of phylogeny and selection pressure in BCR sequences from integrative single-cell sequencing data.”

REGISTER NOW!

Visit the AIRR Community Seminar Series website to learn more about this monthly series and access the recordings of past sessions.

Filed Under: AIRR Community

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

January 2, 2025 by Joshua Dorai

 

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!

Filed Under: Welcoming new TAbS team members!

“Antibodies to Watch in 2025” is now online!

December 24, 2024 by Janice Reichert

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.

 

Filed Under: Antibody therapeutic Tagged With: Antibodies to watch, antibody therapeutics

Greetings, antibody enthusiasts and AE&T 2024 attendees!

December 12, 2024 by Joshua Dorai

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:

  • The latest research and breakthroughs in antibody science.
  • Educational webinars and symposia.
  • Networking opportunities with our society members.
  • Access to the Adaptive Immune Receptor Repertoire (AIRR) Community.

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!

Filed Under: Antibody Engineering & Therapeutics

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mabs

mabs

The Official Journal of The Antibody Society

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The Adaptive Immune Receptor Repertoire Community is a research-driven group organizing around the use of high-throughput sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

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