Panacea Pharmaceuticals, Inc. has announced the issuance of U.S. Patent Number 7,413,737 covering antibodies against human aspartyl (asparaginyl) beta-hydroxylase (HAAH), a proprietary human cancer biomarker and therapeutic target.
These antibodies were developed in collaboration with the Massachusetts Institute of Technology (MIT) and Panacea has exclusive, worldwide rights to this patent for development of human cancer diagnostics and therapeutics. Panacea is developing PAN-622, an all-human sequence anti-HAAH monoclonal antibody covered under this patent, as a cancer therapeutic antibody drug and anticipates the start of Phase 1 clinical trials in early 2009.
HAAH is a cancer molecular marker that has been detected by immunohistochemical staining in a broad range of cancers; this marker was originally discovered at the Rhode Island Hospital / Brown University. Research done both at Panacea and in collaboration with Brown University / Rhode Island Hospital has established HAAH as an excellent drug target for cancer therapy as well as a marker for cancer diagnosis. HAAH over-expression has been observed in more than twenty different cancers, and HAAH has been shown to be highly specific for cancer and absent in adjacent non-affected tissue as well as tissue from cancer-free individuals. In cancer, HAAH is found on the cell surface and in normal cells found in minute quantities inside the cell. As such, HAAH is an excellent therapeutic target. Panacea has demonstrated the efficacy of PAN-622, an all-human sequence anti-HAAH monoclonal antibody, in animal models of cancer. In these experiments PAN-622 inhibited tumor growth in 90 percent of animals, with 40 percent showing no visible tumor. Tumors did not re-grow beyond the period of drug administration. Due to its all human sequence, PAN-622 is anticipated to have low toxicity in humans. And PAN-622 is currently being manufactured under cGMP at high yields. Clinical trials of PAN-622 will be initiated in early 2009, with an initial indication for the treatment of liver cancer. In addition, the presence of HAAH protein in serum has been demonstrated to be highly sensitive and specific for cancer in hundreds of patients with a range of cancer types, and Panacea has developed serum diagnostic tests measuring HAAH for prostate lung, breast and colon cancer.
PAN-622 and other antibodies covered under U.S. Patent Number 7,413,737 were developed in collaboration with MIT using a proprietary yeast display technology. More detailed information is included in Yeung YA, Finney AH, Koyrakh IA, Lebowitz MS, Chanbari HA, Wands JR, Wittrup KD. Isolation and characterization of human antibodies targeting human aspartyl (asparaginyl) beta-hydroxylase. Hum Antibodies, 16(3-4):163-176, 2007.