Biotechnology company Galena Biopharma Inc. has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a Composition of Matter patent covering Folate Binding Peptide (FBP) peptide variants for use either alone or in combination with the FBP vaccine, E39. Additionally, the patent lays the foundation for additional intellectual property for the use of these variants in a novel vaccination strategy that could be applied to any peptide-based vaccine.

“This patent further supports Galena's overall strategy to develop targeted peptide cancer vaccines to prevent or delay cancer recurrence in early stage, adjuvant patients,” said Mark J Ahn, PhD, president and chief executive officer. “Folate targeted therapies are well validated by the industry, and we are excited to continue our work in pursing trials in cancer survivors at high risk for relapse before their disease is detected as metastatic.”

Galena's current FBP vaccine, E39, is in an ongoing phase I/II trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. The company has already designed a new phase I b trial studying the benefit of these FBP peptide variants in combination with E39 that is awaiting Institutional Review Board (IRB) approval.

Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides like E39 that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's FBP vaccine, E39, is currently in a phase I/II trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

Ovarian cancer occurs in over 22,000 patients per year in the US and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20 per cent that of breast cancer, the number of patients that die from ovarian cancer is nearly 50 per cent that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients are routinely surgically debulked to minimal residual disease, and then treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regime and become clinically free of disease, the majority of these patients will relapse, and once the disease recurs, the treatment options and successes drop dramatically.

Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the US annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

Galena Biopharma Inc., a biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.