March 14, 2012
/PRNewswire/ - Oncothyreon Inc. (Nasdaq: ONTY) today announced that the first patient has been enrolled in a Phase 1 trial of ONT-10, a therapeutic vaccine directed at MUC1. The Phase 1 trial is designed to evaluate the safety and immunogenicity of ONT-10 in patients with cancers which commonly express MUC1, including breast, non-small cell lung, ovarian, colorectal, prostate, pancreatic, gastric and other cancers.
"We are excited to begin this trial of our proprietary therapeutic vaccine candidate ONT-10," said
Robert L. Kirkman
, M.D., President and Chief Executive Officer of Oncothyreon. "We hope that this trial will demonstrate in cancer patients that ONT-10 can stimulate both antibodies and immune cells directed at MUC1, as it has in animal models. We are also looking forward to obtaining the first human data with the adjuvant component of ONT-10, a fully synthetic lipid A analog called PET-Lipid A, which was developed at Oncothyreon."
The Phase 1 trial of ONT-10 consists of two parts. Part 1 will study a dose escalation schedule in up to 48 patients to determine the maximally tolerated and/or recommended dose of ONT-10 administered either once every other week or once every week over an 8 week period. Part 2 will further investigate the safety of ONT-10 at the maximally tolerated or recommended dose in up to 15 additional patients at the weekly and/or biweekly schedule. The ability of ONT-10 to induce both a humoral and a cellular immune response will be investigated in both parts of the study.
ONT-10 is a therapeutic vaccine targeting MUC1, a tumor-associated antigen present on many types of human malignant tumors, including lung, breast, colorectal, prostate and ovarian cancer. ONT-10 was designed to stimulate both the humoral and cellular arms of the immune response. Preclinical results demonstrated that administration of ONT-10 produces a robust antibody response in mice specific for human tumor MUC1. A strong cellular immune response directed to the target was also shown. Additionally, the adjuvant component of ONT-10, PET-Lipid A, a fully synthetic toll like receptor 4 (TLR4) agonist discovered by Oncothyreon, was shown to have enhanced potency compared to the adjuvant monophosphoryl lipid A (MPL).