SEOUL, South Korea & ROCHESTER, Minn.--(BUSINESS WIRE)-- VaxOnco, a leading oncology biopharmaceutical company, today announced that following FDA IND approval, it will sponsor a Phase I folate receptor alpha-targeted therapeutic vaccine clinical trial in disease-free patients, previously diagnosed with either breast or ovarian cancer at Mayo Clinic.
The trial stems from a research and a technology license option agreement between Mayo Clinic and VaxOnco and is based on pioneering research into the anti-cancer use of immunogenic peptide epitopes of the Folate Receptor Alpha. The trial is jointly led by Keith Knutson PhD and Kimberly Kalli PhD of Mayo Clinic. According to Dr. Knutson, “Folate receptor alpha is an important immunologic target and existing research shows it to be overexpressed in a large subset of ovarian and breast cancers.”
In the upcoming trial, patients will be pretreated with a single dose of denileukin diftitox, which can heighten immune responses to vaccine. After 3-5 days participants will be given the vaccine, which consists of five peptide epitopes mixed with GM-CSF as an adjuvant to enhance immunity. This trial aims to evaluate the safety of this vaccine as well as immune responses.
According to VaxOnco’s President, Michelle Kim, the trial reflects growing interest in therapeutic vaccines in general: "We are convinced of the potential of therapeutic vaccines to make a major impact in oncology treatment in terms of both increased overall survival periods and improved quality of life by reducing chemotherapy regimes. VaxOnco is therefore delighted to sponsor this trial at Mayo Clinic and hopefully help translate their excellent research into new treatments.”
The trial is due to commence recruitment in 4Q of 2011 and conclude in 2013. According to the research and technology license option agreement with Mayo Clinic, VaxOnco has an exclusive worldwide option to become the exclusive licensee for the sale of any resulting commercial vaccine.
Notes to editors
Headquartered in Korea and part of the KAEL Group. VaxOnco has a prostate cancer product, ONY-P, due to enter a Phase IIb/III trial and an Anti-FRα (anti-folate receptor alpha) breast/ovarian cancer-prophylactic/ therapeutic peptide vaccine due to enter a Phase I trial. www.kaelgemvax.com
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