Daily Rules, Proposed Rules, and Notices of the Federal Government
The following represents the intellectual property to be licensed under the prospective agreement:
With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.
The prospective Exclusive Patent License territory may be worldwide for the following field of use:
“The use of anti-mesothelin targeted immunotoxins for the treatment of mesothelin-expressing cancers, wherein the immunotoxins have:
(1) A targeting domain containing the complementary determining regions (CDRs) of the SS1 antibody; and
For purposes of clarity, the immunotoxin may include additional alterations to B cell and T cell epitopes for the reduction of immunogenicity, a peptide linker sequence, and/or polyethylene glycol molecule(s). The immunotoxins may also be combined with the use of synthetic vaccine particle (SVP)-rapamycin.”
The present inventions to be licensed concern RITs which are targeted to mesothelin-expressing cancer cells, and methods of using the immunotoxins for the treatment of mesothelin-expressing cancers (such as mesothelioma, ovarian cancer and pancreatic cancer). The specific immunotoxin will have an antibody targeting domain that contains the CDRs of the antibody identified as SS1, which was invented at the NIH. The specific immunotoxin will also have a toxin domain derived from PE that is resistant to lysosomal proteases due to the deletion of a large portion of the exotoxin, and which lacks at least one major B-cell epitope due to the alteration an amino acid. Ultimately, the PE used in the immunotoxin may lack multiple B-cell epitopes, as well as multiple T-cell epitopes, in an effort to minimize immunogenicity.
Alterations to the toxin that reduce immunogenicity improve the therapeutic value of the immunotoxin while maintaining its ability to trigger cell death. Since mesothelin is preferentially expressed on certain types of cancer cells, the immunotoxins selectively bind and kill only those cancer cells, allowing healthy, essential cells to remain unharmed. This may result in an effective therapeutic strategy with fewer side effects, especially when combined with agents that can suppress the formation of neutralizing antibodies.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the