The Antibody Society

the official website of the antibody society

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

FDA approves BIZENGRI® (zenocutuzumab-zbco)

by

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®)

by

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.

by

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

by

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!

by

 

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!