Immunotoxin with in-vivo T cell Suppressant Activity
Description of Invention:
The invention concerns immunotoxins and methods of using the immunotoxins for the treatment of autoimmune diseases and T cell malignancies. The immunotoxins are targeted via an antibody that is specific to T cells. This allows the specific ablation of malignant T cells and resting T cells. The transient ablation of resting T cells can "reset" the immune system by accentuating tolerizing responses. The toxin portion of the immunotoxin is genetically engineered to maintain bioactivity when recombinantly produced in Pichia pastoris. Data are available in transgenic animals expressing human CD3epsilon which supports the effects of the immunotoxin against T cells.
Applications:
Treatment of autoimmune diseases such as multiple sclerosis, lupus, type I diabetes, aplastic anemia
Treatment of T cell leukemias and lymphomas such as cutaneous T cell leukemia/lymphoma (CTCL)
Advantages:
Specificity of the immunotoxin avoids the killing of non-T cells, reducing side-effects associated with other mechanisms of treatment (e.g., radiation and cyclophosphamide) such as infection and induced malignancy.
A GMP production process has already been successfully implemented, and patient doses are available.
All testing required for an FDA issued IND has been completed, allowing faster evaluation of the efficacy of the invention.
Benefits:
New methods and compositions with limited side-effects have the potential to revolutionize treatment of autoimmune disease.
Provides an opportunity to capture a significant market share for the millions of people who suffer from an autoimmune disease.
Patent Status:
DHHS Reference No. E-012-1991/0 --
U.S. Patent No. 5,167,956 issued 01 Dec 1992
DHHS Reference No. E-012-1991/2 --
U.S. Patent No. 5,725,857 issued 10 Mar 1998
DHHS Reference No. E-044-1997/0 --
U.S. Patent No. 6,632,928 issued 14 Oct 2003
U.S. Patent Application No. 10/435,567 filed 09 May 2003, which published as 2003/0185825 on 02 Oct 2003
DHHS Reference No. E-044-1997/1 --
U.S. Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 2004/0127682 on 01 Jul 2004
Foreign rights are also available.
Licensing Status: Available for exclusive or non-exclusive licensing.
Collaborative Research Opportunity:
The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of using the immunotoxins for the treatment of autoimmune diseases and T cell malignancies. Please contact David Neville at davidn@mail.nih.gov for more information.
Portfolios: Rare Diseases Internal Medicine Cancer
Cancer -Therapeutics-Immunoconjugates Internal Medicine-Therapeutics-Anti-Inflammatory (including Autoimmune) Cancer -Therapeutics Internal Medicine-Therapeutics
For Additional Information Please Contact: David A. Lambertson Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301)435-4632
Email: lambertsond@mail.nih.gov
Fax: (301) 402-0220
