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Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules Engineered Therapies

Posted Jan 10 2013 7:00pm

Description of Invention:
This technology relates to small (~27 kDa) antibody fragments that are potentially useful for therapeutic development. These are monomeric IgG fragment crystalizable (mFc) compositions; they are long half-lived, functional (pH dependent binders of neonatal Fc receptor - FcRn); and they are soluble and express efficiently in E. coli. These molecules may serve as a platform for development of engineered mFc-based antibodies and fusion proteins with therapeutic applications. Efforts to engineer antibody-based therapeutics, to date, have encountered technical limitations due to the relatively large fragment size and short fragment half-life. The IgG fragment crystalizable (Fc) is a dimer of two constant domains (CH2-CH3 chains). Fc has a long half-life, which makes it promising as a candidate for engineering antibody therapeutics. Fusion proteins based on Fc dimer molecules demonstrate extended half-life, due to the ability to bind FcRn at acidic pH. However, the relatively large size of the Fc domains (~50 kD) is not optimal. This technology uses smaller (~27 kDa) mFc compositions that retain efficient binding to human FcRn and demonstrate long half-life. These mFc compositions are promising for the development of novel therapeutics because the smaller size may allow for superior access to targets and tissues compared to full sized mAbs and larger fragment-based therapeutics, while also retaining important function characteristics.

Applications:
Therapeutics - human and veterinary, engineered antibody and fusion proteins.

Advantages:
Smaller size results better tissue penetration, reduced steric hindrance, increased therapeutic efficiency and lower cost.

Development Status:
  • Early-stage
  • Pre-clinical


Inventors:
Dimiter S Dimitrov (NCI)
Tianlei Ying (NCI)


Patent Status:
HHS, Reference No. E-019-2012/0
US, Application No. 61/612,138 filed 16 Mar 2012


Related Technologies:
US, Application No. 61/063,245 filed 31 Jan 2008, Reference No. E-003-2007/0
US, Application No. 12/864,758 filed 27 Jul 2010, Reference No. E-003-2007/0


Relevant Publication:
  1. Ying T, et al. [ PMID 22518843 ]


Collaborative Research Opportunity:
The NCI/CCR/NP is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Small, Stable, Functional, Soluble, Monomeric IgG1 Fc Molecules Engineered Therapies. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov .


For Licensing Information Please Contact:
Edward (Tedd) Fenn
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: fennea@mail.nih.gov
Phone: 301-435-5031
Fax: 301-402-0220


Ref No: 2512

Updated: 01/2013

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