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Ensituximab

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Ensituximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetMUC5AC
Clinical data
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6342H9800N1678O1985S46
Molar mass142788.68 g·mol−1
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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

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  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.