Recombinant Anti-mesothelin Immunotoxin SS1P (anti-mesothelin dsFv-PE38) as a Therapeutic Agent and Diagnostic Tool for Multiple Cancer Types
Background:
The National Cancer Institute's
Laboratory of Molecular Biology is seeking statements of capability
or interest from parties interested in collaborative research to
further develop or commercialize the anti-mesothelin immunotoxin
SS1P as an anti-tumor agent. Additionally, it can be used for the
detection of mesothelin-expressing cells present in a biological
sample. The technology is also available for exclusive and
non-exclusive licensing.
Technology:
Mesothelin is a glycoprotein,
whose expression has been largely restricted to mesothelial cells
in normal tissues. Mesothelin has been shown to be expressed in
several cancers including mesothelioma, lung cancer, pancreatic
cancers, gastric cancers and ovarian cancers, and has the potential
of being used as a novel target for the development of new
treatments. The SS1P immunotoxin is a recombinant immunotoxin
generated by the fusion of a high affinity anti-mesothelin Fv (SS1)
with a 38 kDa portion of Pseudomonas Exotoxin A (PE38). SS1P can be
used to kill cells expressing mesothelin on their surfaces, such as
mesothelioma, ovarian cancer, lung cancer, pancreatic cancer and
stomach cancer.
Value Proposition:
- SS1P immunotoxin is available for use as a therapy for
mesothelin-expressing cancers;
- Successful clinical testing has been done for the treatment of
mesothelioma and ovarian cancer with low side effects
- Can be used as a stand alone treatment and in combination
chemotherapy.
R&D Status:
- Phase 1 studies have been completed for mesothelin-expressing
cancers such as mesothelioma, ovarian cancer and pancreatic
cancer.
- Animal studies: The combination of Taxol and SS1P exerts a
synergistic antitumor effect in immunodeficient mice implanted with
A431/K5 tumors expressing mesothelin, but not in cell culture. This
effect is not secondary to increased tumor uptake of the
immunotoxin. Synergy could be due to improved immunotoxin
distribution within the tumor or could involve factors released by
other cell types in the tumors..
Further R&D
Needed:
Phase 2 clinical trials of SS1P using SS1P and standard
chemotherapy are being planned for malignant mesothelioma and other
mesothelin-expressing malignancies.
Patent Status:
- U.S. Patents: 7,081,518; 4,892,827; 6,051,405; 5,863,745;
5,696,237; 5,747,654; 6,147,203; 6,558,672; 6,153,430;
6,083,502.
- U.S. Patent Applications: 09/684,599; 09/581,345;
60/681,104
- PCT Applications: PCT/US01/18503 and PCT/US2006/018502
Contact
Information:
John D. Hewes, Ph.D., NCI
Technology Transfer Center
Phone: 301-435-3121
E-mail: Hewesj@mail.nih.gov
Reference: #581 LW
Posted 11/21/2007