Ensituximab

Ensituximab

Monoclonal antibody
Type	Whole antibody
Source	Chimeric (mouse/human)
Target	MUC5AC
Clinical data
ATC code	none
Identifiers
CAS Number	1092658-06-4^N
ChemSpider	none
UNII	F988K568V2
KEGG	D09898^N
Chemical and physical data
Formula	C6342H9800N1678O1985S46
Molar mass	142788.68 g·mol^−1
^NY (what is this?)  (verify)

Ensituximab (NPC-1C) is a chimeric monoclonal antibody under development for as a candidate for treatment of cancers.^[1] The target of the antibody is uncertain and is described as "human colorectal and pancreatic carcinoma-associated antigens", a set of tumor antigens isolated from human cancers.^[2] The target might be Mucin 5AC.^[3]

The antibody was discovered by scientists at Neogenix Oncology using tumor antigens that had been identified years earlier by Ariel Hollinshead; the founder of Neogenix had founded a prior company based on Hollinshead's work as well.^[4] Neogenix worked with Selexis to develop the CHO cell line expressing ensituximab^[5][6] and also worked with Goodwin Biotechnology Inc on process development.^[7]

Ensituximab was granted orphan drug designation for pancreatic cancer by the FDA in 2010.^[8]

In 2011 Neogenix was forced to declare bankruptcy because the SEC opened an investigation into its use of unregistered broker-dealers in the course of raising $30M, and it could not raise further funds; in 2012 Neogenix sold its assets to a group of its investors who had formed a company called Precision Biologics.^[9]

In 2016, Precision released data from a Phase II trial colorectal cancer and at that time was working with Cytovance Biologics as its contract manufacturing organization.^[10]

References

1. "Statement On A Nonproprietary Name Adopted By The USAN Council: Ensituximab" (PDF). American Medical Association.
2. "Ensituximab". NCI Drug Dictionary. Retrieved 31 January 2017.
3. Kim RD, Azad NS, Morse MA, Poplin E, Mahipal A, Tan B, et al. (2020). "Phase II Study of Ensituximab, a Novel Chimeric Monoclonal Antibody, in Adults with Unresectable, Metastatic Colorectal Cancer". Clinical Cancer Research. 26 (14): 3557–3564. doi:10.1158/1078-0432.CCR-20-0426. ISSN 1078-0432. PMID 32303539. S2CID 215809528.
4. Morrison T (July 11, 2007). "Neogenix Uses Cancer Vaccine And Antibody Approaches". BioWorld Today.
5. Neogenix Oncology, Inc. - Pharmaceuticals & healthcare - Deals and alliances profile. (2015). London: Global Data Ltd.
6. "Press ReleaseL Selexis and Neogenix Oncology Execute Commercial License Agreement - Selexis SA". Selexis SA. 5 January 2011.
7. "From Vaccines To Monoclonal Antibodies: Creating Milestones In Cancer Theranostics". Frost & Sullivan. 14 September 2007.
8. Staff (1 December 2010). "FDA Pipeline Preview, December 2010 (Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502)". Formulary Journal. Archived from the original on 2 February 2017. Retrieved 31 January 2017.
9. Davie AJ (5 October 2012). "Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 1: How It All Happened". Strictly Business.. "Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 2: What Neogenix Did". Strictly Business. 24 October 2012.. "Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 3: When the Genie Can't Be Put Back in the Bottle". Strictly Business. 17 November 2012.
10. "Ensituximab - Precision Biologics". Adis Insight. Springer Nature Switzerland AG. Retrieved 30 January 2017.