The Antibody Society

the official website of the antibody society

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

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!

FDA approves Vyloy (zolbetuximab-clzb)

by

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!

by

 

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.

2024 James S. Huston Antibody Science Talent Award recipient is announced!

by

We are delighted to announce that Dr. Jenna Guthmiller has been selected as the 2024 James S. Huston Antibody Science Talent Award Recipient!

Dr. Jenna Guthmiller is an Assistant Professor in the Department of Immunology and Microbiology at the University of Colorado Anschutz Medical Campus.

Jenna received her undergraduate degree from South Dakota State University in 2013 and her PhD from the University of Oklahoma Health Sciences Center in 2017. She conducted her postdoctoral research at the University of Chicago and established her lab at the University of Colorado in 2022.

Dr. Guthmiller’s research focuses on understanding how broadly protective humoral immunity against rapidly evolving pathogens develops and can be harnessed by next-generation vaccines.

Jenna has received numerous awards and accolades, including a NIH Pathway to Independence Award, NIH Director’s New Innovator Award, U.S. National Academy of Sciences Kavli Fellowship, The Michelson Prize for Human Immunology, the European Scientific Working Group on Influenza and Other Respiratory Viruses Young Scientist Vaccine Innovation Award, and the American Society for Virology Ann Palmenberg Junior Investigator Award.

Dr. Guthmiller will give a lecture on her work at the Antibody Engineering and Therapeutics conference in San Diego, California (December 15 – 18, 2024), as well as in a post-meeting webinar. The lecture will be made freely available on-demand on The Antibody Society’s YouTube Channel.

FDA approves HYMPAVZI™ (marstacimab-hncq)

by

On October 11, 2024, Pfizer Inc. announced that the U.S. Food and Drug Administration approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. Marstacimab is an IgG1l monoclonal antibody targeting tissue factor pathway inhibitor, a single-chain polypeptide that can reversibly inhibit Factor Xa. The antibody’s Fc mutations (L234A, L235A, G237A) impair Fc effector functions.

HYMPAVZI  is the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. The approval was based on results of the Phase 3 BASIS study (NCT03938792), which evaluated the efficacy and safety marstacimab in adult and teenage participants with severe hemophilia A or moderately severe to severe hemophilia B.  In the study, HYMPAVZI reduced the annualized bleeding rate (ABR) for treated bleeds by 35% and 92% after a 12-month active treatment period compared to routine prophylaxis and on-demand treatment, respectively, in patients with hemophilia A or B without inhibitors. The safety profile for HYMPAVZI was consistent with Phase 1/2 results.

In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for marstacimab for the routine prophylaxis of bleeding episodes in adults and adolescents 12 years and older with severe hemophilia A without FVIII inhibitors, or severe hemophilia B without FIX inhibitors. A decision by the European Commission is expected by the end of 2024.

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