and methods of use in Australia, Switzerland, Germany, Spain, France, Great Britain, and Italy, and an issued Canadian patent covering the composition of matter and method of use. The U.S. patent
on the
WT1-A1
peptide (U.S. Patent No. 7,488,718) will expire on March 22, 2026, including patent term adjustment, and the foreign patents will expire on November 30, 2024, absent patent term
extension.
We have licensed, issued patents covering the composition of matter of the
WT1-427
long peptide, and
methods of use, in the United States, Australia, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, and Canada. The United States composition of matter patent on the
WT1-427
long peptide (U.S.
Patent No. 8,765,687) will expire on October 26, 2031, including patent term adjustment. The United States method of use patent (U.S. Patent No. 9,233,149) will expire on October 17, 2026, absent patent term extension, and covers
treating a subject with a
WT1-expressing
cancer, reducing an incidence of a
WT1-expressing
cancer, or its relapse, and inducing the formation and proliferation of a
cytotoxic T lymphocyte specific for a
WT1-expressing
cancer. The foreign patents will expire on October 17, 2026, absent patent term extension.
We have licensed, issued patents covering the composition of matter of the
WT1-331
long peptide, and methods of use,
in the United States, Australia, Switzerland, Germany, Spain, France, Great Britain, Ireland, and Italy. The United States composition of matter patent on the
WT1-331
long peptide (U.S. Patent
No. 8,765,687) will expire on October 26, 2031, including patent term adjustment. The United States method of use patent (U.S. Patent No. 9,233,149) will expire on October 17, 2026, absent patent term extension, and covers
treating a subject with a
WT1-expressing
cancer, reducing an incidence of a
WT1-expressing
cancer, or its relapse, and inducing the formation and proliferation of a
cytotoxic T lymphocyte specific for a
WT1-expressing
cancer. The foreign patents will expire on October 17, 2026, absent patent term extension.
We have a licensed, issued United States patent covering the composition of matter of the
WT1-1221A1
long peptide, and
issued patents covering the composition of matter and methods of use, in Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Romania, and Turkey. The United States composition
of matter patent on the
WT1-1221A1
long peptide (U.S. Patent No. 9,265,816) will expire on February 20, 2033, including patent term adjustment. The European patents will expire on April 10,
2027, absent patent term extension, and cover the composition of matter and use of the peptide for the preparation of a medicament for treating a
WT1-expressing
cancer or for reducing an incidence of a
WT1-expressing
cancer or its relapse in a subject.
We are pursuing additional patent protection through pending patent
applications for compositions of matter and methods of use for the
WT1-331
long peptide and
WT1-122A1
long peptide in Canada, and method of use for the
WT1-122A1
long peptide in the United States. Although we are pursuing additional patent protection for these peptide components through pending patent applications, we may not be able to obtain additional patent
protection that would provide us with a significant commercial advantage. The active peptide found in NeuVax, the E75 peptide, has been known and studied for many years. We have one issued U.S. patent, US 6,514,942, covering the composition of
matter of the E75 peptide, which expired in
mid-2015,
prior to any potential commercialization of NeuVax. We do not have and will not be able to obtain any composition of matter patent protection for E75, the
active peptide in NeuVax. We also have a license from HJF to issued United States, European, Japanese, Korean, Mexican and Australian method of use patents, which expire in 2028, that are directed to a method of inducing immunity against breast
cancer recurrence by administering a composition comprising the E75 peptide to patients who have both an immunohistochemistry, or IHC, rating of 1+ or 2+ for HER2/neu protein expression, as well as a fluorescence in situ hybridization, or FISH,
rating of less than about 2.0 for HER2/neu gene expression. The license further includes issued patents in the United States, Australia and Japan, and allowed patent applications in Canada and Korea, with claims directed to a method of inducing
immunity against recurrence of any HER2/neu expressing tumors by administering the E75 peptide to patients with tumors having a FISH rating of less than about 2.0 for HER2/neu gene expression; an issued U.S. patent that includes claims to the use of
E75 to reduce the risk of cancer recurrence, including bone only recurrence; and pending applications with similar claims in a number of foreign jurisdiction, all of which expire in 2028. Also included in the license are method of use patents in the
United States and Australia, which expires in 2026, that
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