Government Owned Invention Available for License: Monoclonal Antibody (RO4) That Reacts With the Juxta-Membrane Region of Mesothelin

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The National Cancer Institute (NCI) seeks research co-development partners and/or licensees for a novel monoclonal antibody (mAb), RO4, that can be used to treat mesothelin (MSLN) expressing cancers. FOR FURTHER INFORMATION CONTACT: Inquiries related to this license opportunity should be directed to: Laurie Whitney, Ph.D., Unit Supervisor, NCI, Technology Transfer Center, Email: WhitneyL@mail.nih.gov or Phone: 240-276-5505. SUPPLEMENTARY INFORMATION: Mesothelin (MSLN) is a surface antigen ( printed page 52065) highly expressed in many solid tumors, such as mesothelioma, ovarian, and pancreatic cancers. MSLN is present at relatively low levels in mesothelial cells of healthy individuals, making it an ideal candidate for targeted therapeutics. However, the efficacy of MSLN-targeted agents is often reduced as a portion of the protein is shed from the cell surface and binds to available anti-MSLN antibodies. This reduces therapeutic engagement at the cell surface as shed MSLN acts as a decoy within tumor microenvironments, limiting antibodies from reaching and destroying tumor cells. Researchers at the NCI developed a novel mAb, RO4, which specifically binds to the juxta-membrane region of MSLN to block shedding. RO4 binds to the same region of MSLN as a previously developed mAb, 15B6 (NCI Ref. #E-106-2017), but in a different conformation. Th…