The Antibody Society

the official website of the antibody society

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

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Bispecific antibodies (bsAbs) are making waves in the biotherapeutics world, especially in oncology and immunotherapy. But how can we accelerate the discovery process and pinpoint the best candidates?

In this webinar, Dr. Francisco Ylera, head of R&D at Bio-Rad Laboratories, will share how SpyLock Technology is revolutionizing bispecific antibody discovery!

You will learn:

• How SpyLock uses the SpyCatcher-SpyTag system to quickly assemble and screen hundreds of bsAbs

• Integration with Bio-Rad’s Pioneer™ Antibody Discovery Platform for high-throughput screening

• A real-world case study showcasing how SpyLock has helped identify the most promising bispecific candidates

This is a great opportunity for anyone looking to stay ahead in bispecific antibody research!

👉 Register here to secure your spot!

About speaker:

Francisco Ylera is the head of the R&D team that generated the Pioneer Antibody Discovery Platform and developed the SpyLock Technology for bispecific generation and screening. He has been with Bio-Rad for over 20 years and works on customer antibody generation projects designing the selection, antibody characterization, and method optimizations. Francisco has contributed to over 25 publications, patents and book chapters, earning more than 480 citations. Francisco holds a diploma in chemistry from RWTH Aachen University, Germany, and a Ph.D. in biochemistry from the Free University Berlin, Germany. After his Ph.D., he did a postdoc at the Harvard Institute of Medicine, Boston, USA.

https://www.antibodysociety.org/upcoming-webinars/19183/

Register now for the Nov 21st AIRR Community Seminar Series

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Registration for the November 21st (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.

Camilla Engblom, of Karolinska University, Sweden, will present “Spatially resolving antigen receptors in tissues. “Next, Roy Ehling, Engimmune, Switzerland will present “Synthetic co-evolution of neutralizing antibodies with SARS-CoV-2.”

REGISTER NOW!

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

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!

FDA approves Vyloy (zolbetuximab-clzb)

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On October 18, 2024, the US Food and Drug Administration (FDA) approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.) for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test. FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to identify patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with zolbetuximab.

The recommended zolbetuximab-clzb dosage with fluoropyrimidine- and platinum-containing chemotherapy is 800 mg/m2 intravenously (IV) as the first dose, with subsequent dosages of 600 mg/m2 IV every 3 weeks, or 400 mg/m2 IV every 2 weeks.

Zolbetuximab is a chimeric IgG1 antibody targeting Claudin 18.2 (CLDN18.2) originally developed by Ganymed Pharmaceuticals AG, which was acquired by Astellas. Japan’s Ministry of Health, Labour and Welfare approved VYLOY™ for patients with CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer in March 2024 and zolbetuximab was subsequently approved for untreated CLDN18.2-positive, HER2-negative unresectable advanced G/GEJ adenocarcinoma in the United Kingdom and the European Union in August and September 2024, respectively.

The marketing approvals were based on data from the Phase 3 SPOTLIGHT (NCT03504397) and GLOW clinical trials (NCT03653507). Both were randomized (1:1), double-blind, multicenter trials that included patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic G/GEJ adenocarcinoma. The SPOTLIGHT trial included 565 patients randomized to receive either zolbetuximab (800 mg/m2 loading dose administered IV followed by 600 mg/m2 every 3 weeks) plus mFOLFOX6 chemotherapy (283 patients) or placebo plus mFOLFOX6 (282 patients). The GLOW study evaluated zolbetuximab plus capecitabine and oxaliplatin as first-line treatment in 507 patients.

In the SPOTLIGHT study, the median progression-free survival (PFS) was 10.6 months (95% CI: 8.9, 12.5) in the zolbetuximab-clzb/chemotherapy arm and 8.7 months (95% CI: 8.2, 10.3) in the placebo/chemotherapy arm (hazard ratio [HR] 0.751 [95% CI: 0.598, 0.942]; 1-sided p-value=0.0066). Median overall survival (OS) was 18.2 months (95% CI: 16.4, 22.9) and 15.5 months (95% CI: 13.5, 16.5), respectively, (HR 0.750 [95% CI: 0.601, 0.936]; 1-sided p-value=0.0053).

In the GLOW study, the median PFS was 8.2 months (95% CI: 7.5, 8.8) in the zolbetuximab-clzb/chemotherapy arm and 6.8 months (95% CI: 6.1, 8.1) in the placebo/chemotherapy arm (hazard ratio [HR] 0.687 [95% CI: 0.544, 0.866]; 1-sided p-value=0.0007). Median OS was 14.4 months (95% CI: 12.3, 16.5) and 12.2 months (95% CI: 10.3, 13.7), respectively (HR 0.771 [95% CI: 0.615, 0.965]; 1-sided p-value=0.0118).

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

Register now for the October 24 AIRR Community Seminar Series!

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Registration for the October 24th (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.

Scott Boyd, of Stanford University, USA, will present “Analysis of human B cell responses in vaccination, infection and allergy with large multiplexed antigen panels.” Next, Suhas Sureshchandra, University of California Irvine, USA, will present “Tissue determinants of the human T cell receptor repertoire.”

REGISTER NOW!

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