Anti-Human CEACAM5 (CD66e) (Labetuzumab)

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 Labetuzumab. hMN-14 (Labetuzumab) activity is directed against human CEACAM5.

CEACAM5 is a member of the carcinoembryonic antigen-related cellular adhesion molecules (CEACAM) family¹. In normal tissues, CEACAM5 functions as an adhesion molecule and has roles in differentiation, immune modulation, and anoikis inhibition. Additionally, CEACAM5 likely inhibits terminal differentiation and is also involved in activation of CD8⁺ suppressor T cells. Dysregulation of CEACAM5 has been implicated in tumor initiation, progression, invasion, and metastasis^1,2 as well as in immune-related disease, particularly ulcerative colitis¹. CEACAM5 is a clinical biomarker for colon cancer¹ and is also a promising target of anti-cancer immunotherapy². CEACAM5 is a mediator of CEACAM1-induced apoptosis, and preventing this interaction may prove beneficial to cancer treatment by blocking immune evasion by cancer cells.

hMN-14 (Labetuzumab; IMMU-130) is a CEACAM5 antibody-drug conjugate composed of a humanized CEACAM5 monoclonal antibody conjugated via the hydrolysable linker CL2A to 7- ethyl-10-hydroxycamptothecin (SN-38), a potent topoisomerase I inhibitor^3,4. The antitumor activity of labetuzumab has been tested for colorectal^4,7 and prostate cancers².

This non-therapeutic biosimilar is not a drug conjugate and thus does not contain the drug SN- 38.

In normal tissues, CEACAM5 is expressed on gastric and intestinal mucous cells, particularly esophageal squamous epithelia, as well as in the pancreas. In cancers, CEACAM5 is expressed on the majority of solid tumors and is upregulated in a variety of human epithelial malignancies (gastric, colorectal, pancreatic cancers) as well as in non-small cell lung cancer and melanoma. Tumors release CEACAM5 in a soluble form that can be used as a biomarker for cancer.

CEACAM1

1. Thomas J, Klebanov A, John S, et al. Genes Cancer. 14:12-29. 2023.
2. DeLucia DC, Cardillo TM, Ang L, et al. Clin Cancer Res. 27(3):759-774. 2021.
3. Sharkey RM, Juweid M, Shevitz J, et al. Cancer Res. 55(23 Suppl):5935s-5945s. 1995.
4. Govindan SV, Cardillo TM, Moon SJ, et al. Clin Cancer Res. 15(19):6052-6061. 2009.
5. Shinmi D, Nakano R, Mitamura K, et al. Cancer Med. 6(4):798-808. 2017.
6. Iwano J, Shinmi D, Masuda K, et al. Drug Metab Dispos. 47(11):1240-1246. 2019.
7. Govindan SV, Cardillo TM, Rossi EA, et al. Mol Pharm. 12(6):1836-47. 2015.
8. Sharkey RM, Govindan SV, Cardillo TM, et al. Mol Cancer Ther. 17(1):196-203. 2018.
9. de Gooyer JM, Elekonawo FMK, Bremers AJA, et al. Nat Commun. 13(1):2621. 2022.
10. Imberti C, De Gregorio R, Korsen JA, et al. J Nucl Med. 65(7):1043-1050. 2024.