Anti-Human Trophoblast Cell Surface Antigen 2 (TROP-2) (Sacituzumab) – Fc Muted™

Parental murine clone RS7 developed by immunizing mice with cell membranes isolated from squamous non-small cell lung cancer.

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 preclinical 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 ≤ -70°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 Sacituzumab. IMMU-132 (Sacituzumab) activity is directed against human TROP-2.

Trophoblast cell surface antigen 2 (TROP-2), also known as tumor-associated calcium signal transducer 2 (TACSTD2), is a cell surface glycoprotein that plays roles in cell-cell adhesion¹, cell proliferation, invasion, migration, and apoptosis in healthy tissues as well as tumorigenesis in cancers². TROP-2 acts as a transmembrane transducer of intracellular calcium signals. In cancer, TROP-2 is necessary and sufficient to drive cancer growth¹ and promotes migration and invasion of cancer cells by regulating the calcium ion signaling pathway and cyclin expression, stimulating ERK signaling, and reducing fibronectin adhesion². TROP-2 stimulates proliferation in some cancers (cervical, bladder) but suppresses proliferation in others (cholangiocarcinoma, MCF7 breast cancer cell lines). TROP-2 is a target for the treatment of advanced metastatic cancers.

IMMU-132 (Sacituzumab) is an antibody-drug conjugate developed as an immunotherapy against cancer³. Sacituzumab was developed by site-specific conjugation of SN-38, an irinotecan active metabolite that acts as a DNA topoisomerase I inhibitor, to hRS7, a humanized monoclonal antibody against TROP-2. The original RS7 is a murine monoclonal antibody developed by immunizing mice with cell membranes isolated from squamous non-small cell lung cancer⁴. SN-38 is covalently linked to hRS7 via a hydrolyzable CL2A linker³. SN-38 is moderately toxic and is conjugated to hRS7 at a high mean drug-to-antibody ratio. Sacituzumab activity is performed.

This non-therapeutic biosimilar antibody is not conjugated to SN-38.

TROP-2 is expressed in many normal tissues and is overexpressed in a variety of tumors, including pancreatic, ovarian, prostate, and breast cancers. TROP-2 was first identified in human placental trophoblasts.

N/A

1 Guerra E, Trerotola M, Aloisi AL, et al. Oncogene. 32(12):1594-1600. 2013.
2 Wen Y, Ouyang D, Zou Q, et al. Ann Transl Med. 10(24):1403. 2022.
3 Syed YY. Drugs. 80(10):1019-1025. 2020.
4 Goldenberg DM, Stein R, Sharkey RM. Oncotarget. 9(48):28989-29006. 2018.
5 Cardillo TM, Govindan SV, Sharkey RM, et al. Clin Cancer Res. 17(10):3157-3169. 2011.
6 Goldenberg DM, Cardillo TM, Govindan SV, et al. Oncotarget. 6(26):22496-22512. 2015.
7 Chang CH, Wang Y, Zalath M, et al. Mol Cancer Ther. 15(8):1910-1919. 2016.