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Homepage of The Antibody Society
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href="https://www.antibodysociety.org/snakebite-antivenoms-global-challenges-and-progress-toward-recombinant-antibody-therapeutics/"><span >Snakebite antivenoms: Global challenges and progress toward recombinant antibody therapeutics</span></a></li> </ul> </li> </ul></div></nav><div class="site-inner"><div class="content-sidebar-wrap"><main class="content"><article class="post-19199 post type-post status-publish format-standard category-antibody-therapeutic category-food-and-drug-administration tag-antibody-therapeutics tag-approved-antibodies tag-food-and-drug-administration tag-zanidatamab tag-ziihera pmpro-has-access entry" aria-label="FDA approves zanidatamab (Ziihera®)"><header class="entry-header"><h2 class="entry-title"><a class="entry-title-link" rel="bookmark" href="https://www.antibodysociety.org/food-and-drug-administration/fda-approves-zanidatamab-ziihera/">FDA approves zanidatamab (Ziihera®)</a></h2> <p class="entry-meta"><time class="entry-time">November 21, 2024</time> by <span class="entry-author"><a href="https://www.antibodysociety.org/author/janreichert/" class="entry-author-link" rel="author"><span class="entry-author-name">Janice Reichert</span></a></span> </p></header><div class="entry-content"><p><a href="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg"><img decoding="async" class="alignleft wp-image-2125" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg" alt="" width="214" height="214" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg 300w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars-150x150.jpg 150w" sizes="(max-width: 214px) 100vw, 214px" /></a>On November 20, 2024, Jazz Pharmaceuticals announced that <a href="https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-ziiherar" target="_blank" rel="noopener"><strong>FDA granted accelerated approval of Ziihera®</strong></a> (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.</p> <p>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.</p> <p>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].</p> <p>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.</p> [1] ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.</p> </div><footer class="entry-footer"><p class="entry-meta"><span class="entry-categories">Filed Under: <a href="https://www.antibodysociety.org/antibody-therapeutic/" rel="category tag">Antibody therapeutic</a>, <a href="https://www.antibodysociety.org/food-and-drug-administration/" rel="category tag">Food and Drug Administration</a></span> <span class="entry-tags">Tagged With: <a href="https://www.antibodysociety.org/tag/antibody-therapeutics/" rel="tag">antibody therapeutics</a>, <a href="https://www.antibodysociety.org/tag/approved-antibodies/" rel="tag">approved antibodies</a>, <a href="https://www.antibodysociety.org/tag/food-and-drug-administration/" rel="tag">Food and Drug Administration</a>, <a href="https://www.antibodysociety.org/tag/zanidatamab/" rel="tag">zanidatamab</a>, <a href="https://www.antibodysociety.org/tag/ziihera/" rel="tag">Ziihera</a></span></p></footer></article><article class="post-19183 post type-post status-publish format-standard category-upcoming-webinars pmpro-has-access entry"><header class="entry-header"><p class="entry-meta"><time class="entry-time">November 19, 2024</time> by <span class="entry-author"><a href="https://www.antibodysociety.org/author/joshuadorai/" class="entry-author-link" rel="author"><span class="entry-author-name">Joshua Dorai</span></a></span> </p></header><div class="entry-content"><p><a href="https://webinars-antibodysociety.org/store/seminar/seminar.php?seminar=204017"><img fetchpriority="high" decoding="async" class="alignleft size-large wp-image-19179" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Bio-Rad-Linkedin-promotional-banner-1024x316.jpg" alt="" width="1024" height="316" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Bio-Rad-Linkedin-promotional-banner-1024x316.jpg 1024w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Bio-Rad-Linkedin-promotional-banner-300x93.jpg 300w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Bio-Rad-Linkedin-promotional-banner-768x237.jpg 768w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Bio-Rad-Linkedin-promotional-banner.jpg 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></p> <p>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?</p> <p>In this webinar, Dr. <a href="https://www.linkedin.com/company/11819426/admin/page-posts/published/?share=true#"><span class="s2">Francisco Ylera</span></a>, head of R&D at Bio-Rad Laboratories, will share how SpyLock Technology is revolutionizing bispecific antibody discovery!</p> <p class="p1"><b>You will learn:</b><b></b></p> <p class="p1">• How SpyLock uses the SpyCatcher-SpyTag system to quickly assemble and screen hundreds of bsAbs</p> <p class="p1">• Integration with Bio-Rad’s Pioneer™ Antibody Discovery Platform for high-throughput screening</p> <p>• A real-world case study showcasing how SpyLock has helped identify the most promising bispecific candidates</p> <p>This is a great opportunity for anyone looking to stay ahead in bispecific antibody research!</p> <h3><span class="s3">👉</span><b><a href="https://webinars-antibodysociety.org/store/seminar/seminar.php?seminar=204017"> Register here</a> to secure your spot!</b></h3> <p><strong>About speaker:</strong></p> <p><a href="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Francisco-Ylera-Ph.D.-head-shot.png"><img decoding="async" class="alignleft wp-image-19180 size-thumbnail" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Francisco-Ylera-Ph.D.-head-shot-150x150.png" sizes="(max-width: 150px) 100vw, 150px" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Francisco-Ylera-Ph.D.-head-shot-150x150.png 150w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Francisco-Ylera-Ph.D.-head-shot-300x300.png 300w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/Francisco-Ylera-Ph.D.-head-shot.png 490w" alt="" width="150" height="150" /></a></p> <p><strong>Francisco Ylera</strong> 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.</p> <p class="entry-permalink"><a href="https://www.antibodysociety.org/upcoming-webinars/19183/" rel="bookmark">https://www.antibodysociety.org/upcoming-webinars/19183/</a></p></div><footer class="entry-footer"><p class="entry-meta"><span class="entry-categories">Filed Under: <a href="https://www.antibodysociety.org/upcoming-webinars/" rel="category tag">Upcoming Webinars</a></span> </p></footer></article><article class="post-19169 post type-post status-publish format-standard category-airr-community pmpro-has-access entry" aria-label="Register now for the Nov 21st AIRR Community Seminar Series"><header class="entry-header"><h2 class="entry-title"><a class="entry-title-link" rel="bookmark" href="https://www.antibodysociety.org/airr-community/register-now-for-the-nov-21st-airr-community-seminar-series/">Register now for the Nov 21st AIRR Community Seminar Series</a></h2> <p class="entry-meta"><time class="entry-time">November 18, 2024</time> by <span class="entry-author"><a href="https://www.antibodysociety.org/author/pam/" class="entry-author-link" rel="author"><span class="entry-author-name">Pam Borghardt</span></a></span> </p></header><div class="entry-content"><p><a href="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/thumbnail_AIRR-Community-Seminar-Series-November-2024-Event.png"><img loading="lazy" decoding="async" class="alignleft size-full wp-image-19159" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/thumbnail_AIRR-Community-Seminar-Series-November-2024-Event.png" alt="" width="640" height="360" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/thumbnail_AIRR-Community-Seminar-Series-November-2024-Event.png 640w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/11/thumbnail_AIRR-Community-Seminar-Series-November-2024-Event-300x169.png 300w" sizes="(max-width: 640px) 100vw, 640px" /></a></p> <p>Registration for the <strong>November 21st (4:00 PM – 5:30 PM CET)</strong> 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.</p> <p><strong>Camilla Engblom, of Karolinska University, Sweden</strong>, will present “Spatially resolving antigen receptors in tissues. “Next, <strong>Roy Ehling, Engimmune, Switzerland</strong> will present “Synthetic co-evolution of neutralizing antibodies with SARS-CoV-2.”</p> <h2><a href="https://us06web.zoom.us/meeting/register/tZIqdemprz4sHNQXw3qe6mK39-wur4mgEejG">REGISTER NOW!</a></h2> <p>Visit the <strong><a href="https://www.antibodysociety.org/the-airr-community/airr-community-seminar-series/">AIRR Community Seminar Series website</a></strong> to learn more about this monthly series and access the recordings of past sessions.</p> </div><footer class="entry-footer"><p class="entry-meta"><span class="entry-categories">Filed Under: <a href="https://www.antibodysociety.org/airr-community/" rel="category tag">AIRR Community</a></span> </p></footer></article><article class="post-19068 post type-post status-publish format-standard category-welcoming-new-tabs-team-members pmpro-has-access entry has-post-thumbnail" aria-label="Welcoming Kristen McPike to the TAbS team!"><header class="entry-header"><h2 class="entry-title"><a class="entry-title-link" rel="bookmark" href="https://www.antibodysociety.org/ab-news/welcoming-new-tabs-team-members/welcoming-kristen-mcpike-to-the-tabs-team/">Welcoming Kristen McPike to the TAbS team!</a></h2> <p class="entry-meta"><time class="entry-time">October 29, 2024</time> by <span class="entry-author"><a href="https://www.antibodysociety.org/author/joshuadorai/" class="entry-author-link" rel="author"><span class="entry-author-name">Joshua Dorai</span></a></span> </p></header><div class="entry-content"><a class="entry-image-link" href="https://www.antibodysociety.org/ab-news/welcoming-new-tabs-team-members/welcoming-kristen-mcpike-to-the-tabs-team/" aria-hidden="true" tabindex="-1"><img width="291" height="300" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/10/Screenshot-2024-10-29-at-6.13.32 PM-291x300.png" class="alignleft post-image entry-image" alt="" decoding="async" loading="lazy" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/10/Screenshot-2024-10-29-at-6.13.32 PM-291x300.png 291w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/10/Screenshot-2024-10-29-at-6.13.32 PM-768x793.png 768w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2024/10/Screenshot-2024-10-29-at-6.13.32 PM.png 920w" sizes="(max-width: 291px) 100vw, 291px" /></a><p> </p> <p>We are very pleased to announce that Kristen McPike has joined us as a Program and Alliance Manager.</p> <p>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!</p> </div><footer class="entry-footer"><p class="entry-meta"><span class="entry-categories">Filed Under: <a href="https://www.antibodysociety.org/ab-news/welcoming-new-tabs-team-members/" rel="category tag">Welcoming new TAbS team members!</a></span> </p></footer></article><article class="post-19034 post type-post status-publish format-standard category-antibody-therapeutic category-approvals category-food-and-drug-administration tag-antibody-therapeutics tag-approved-antibodies tag-food-and-drug-administration pmpro-has-access entry" aria-label="FDA approves Vyloy (zolbetuximab-clzb)"><header class="entry-header"><h2 class="entry-title"><a class="entry-title-link" rel="bookmark" href="https://www.antibodysociety.org/antibody-therapeutic/fda-approves-vyloy-zolbetuximab-clzb/">FDA approves Vyloy (zolbetuximab-clzb)</a></h2> <p class="entry-meta"><time class="entry-time">October 20, 2024</time> by <span class="entry-author"><a href="https://www.antibodysociety.org/author/janreichert/" class="entry-author-link" rel="author"><span class="entry-author-name">Janice Reichert</span></a></span> </p></header><div class="entry-content"><p><a href="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg"><img loading="lazy" decoding="async" class="alignleft wp-image-2125" src="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg" alt="" width="202" height="202" srcset="https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars.jpg 300w, https://www.antibodysociety.org/wordpress/wp-content/uploads/2018/02/picture4_biosimilars-150x150.jpg 150w" sizes="(max-width: 202px) 100vw, 202px" /></a>On October 18, 2024, the US <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma" target="_blank" rel="noopener"><strong>Food and Drug Administration (FDA) approved zolbetuximab-clzb</strong> </a>(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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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).</p> <p>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).</p> <h3><em>Curious about what other antibody therapeutics are approved or in regulatory review? Our<a href="https://www.antibodysociety.org/antibody-therapeutics-product-data/"> online table</a> contains details for over 200 such antibodies! </em></h3> </div><footer class="entry-footer"><p class="entry-meta"><span class="entry-categories">Filed Under: <a href="https://www.antibodysociety.org/antibody-therapeutic/" rel="category tag">Antibody therapeutic</a>, <a href="https://www.antibodysociety.org/approvals/" rel="category tag">Approvals</a>, <a href="https://www.antibodysociety.org/food-and-drug-administration/" rel="category tag">Food and Drug Administration</a></span> <span class="entry-tags">Tagged With: <a href="https://www.antibodysociety.org/tag/antibody-therapeutics/" rel="tag">antibody therapeutics</a>, <a href="https://www.antibodysociety.org/tag/approved-antibodies/" rel="tag">approved antibodies</a>, <a href="https://www.antibodysociety.org/tag/food-and-drug-administration/" rel="tag">Food and Drug Administration</a></span></p></footer></article><div 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