Anti-Human Claudin-18.2 (Zolbetuximab) – Fc Muted™

This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration.

Liquid

Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates.

To protect mouse colonies from infection by pathogens and to assure that experimental preclinical data is not affected by such pathogens, all of Leinco’s recombinant biosimilar antibodies are tested and guaranteed to be negative for all pathogens in the IDEXX IMPACT I Mouse Profile.

Functional grade biosimilar antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at -80°C. Avoid Repeated Freeze Thaw Cycles.

Research Use Only

2 – 8° C Wet Ice

This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Zolbetuximab . Zolbetuximab (IMAB-362) is a chimeric IgG1 monoclonal antibody that specifically targets Claudin 18.2.

CLDN18.2 is a protein that is overexpressed in various cancers, including gastric, pancreatic, and esophageal cancers, making it a valuable therapeutic target. It plays a key role in carcinogenesis, cell polarity, and intercellular adhesion. Monoclonal antibodies like zolbetuximab have shown potential in treating advanced cancers with minimal adverse effects, positioning CLDN18.2 as a promising focus for cancer therapy. A deeper understanding of CLDN18.2's functions is crucial for developing effective treatments, especially for patients with poor prognoses^1-3.

Zolbetuximab (IMAB362) has demonstrated promise in treating advanced gastric and gastroesophageal junction cancers by targeting CLDN18.2. Clinical trials have shown that Zolbetuximab is well-tolerated and effective, inducing antitumor activity through antibody- dependent cellular cytotoxicity and complement-dependent cytotoxicity. Preclinical studies also support its use in combination with standard chemotherapy, further enhancing its potential as a cancer treatment^4-6.

Claudin 18.2 is a highly selective marker with limited expression in normal tissues but is often abnormally expressed in various primary malignant tumors, such as gastric cancer, pancreatic cancer, and others.

YAP1

1. Zhu G, Foletti D, Liu X, et al. Sci Rep. 2019;9(1):8420.
2. Sahin U, Koslowski M, Dhaene K, et al. Clin Cancer Res. 2008;14(23):7624-7634.
3. Jiang H, Shi Z, Wang P, et al. J Natl Cancer Inst. 2019;111(4):409-418.
4. Sahin U, Schuler M, Richly H, et al. Eur J Cancer. 2018;100:17-26.
5. H BM, U E, Cr S, et al. Oncoimmunology. 2023;12(1).
6. Türeci Ӧzlem, Mitnacht-Kraus R, Wöll S, Yamada T, Sahin U. Oncoimmunology.2019;8(1):e1523096.
7. Zolbetuximab Chimeric Recombinant Monoclonal Antibody (MA5-42158). Accessed October 4, 2024. https://www.thermofisher.com/antibody/product/Zolbetuximab-Chimeric-Antibody-Recombinant-Monoclonal/MA5-42158