GAITHERSBURG, Md., Feb. 1, 2018 /PRNewswire/ — Panacea Pharmaceuticals, a clinical stage biopharmaceutical company developing novel biologically-targeted cancer therapies and diagnostics for unmet medical needs, announced today the completion of patient enrollment in an open-label, parallel-designed, multi-center Phase 1 clinical trial of PAN-301-1 for the treatment of persistent prostate cancer to assess safety and immunogenicity.
PAN-301-1 is a novel nanoparticle immunotherapy vaccine candidate targeting human aspartyl (asparaginyl) β-hydroxylase (HAAH) also known as aspartate β-hydroxylase (ASPH).
In the Phase 1 trial, PAN-301-1 is being administered via intradermal injection in patients with biochemically relapsed prostate cancer, using a fixed dose-escalation schema every 21 days to establish the recommended Phase 2 dose. Twelve patients have been enrolled. A minimum of 3 doses of vaccine are administered to each subject. Based on this announced completion of study enrollment, the trial will conclude in the first half of 2018. Highlights of the initial safety and immunogenicity data to date are as follows:
The PAN-301-1 therapeutic vaccine has been well tolerated with a highly favorable safety profile across all dose levels in the Phase 1 study. No drug-related adverse events or dose-limiting toxicities have been observed at any of the three vaccine dose levels evaluated. All subjects experienced dose-dependent HAAH-specific immune responses, including antibody levels in immunoassays and B-cell and T-cell responses. A majority of subjects treated beyond 3 months achieved a reduction in Prostate Specific Antigen (PSA) doubling rate (a measure of disease progression) and are receiving continued PAN-301-1 doses at the Investigator’s discretion.
“We are extremely pleased by the rapid progress of our first clinical study of PAN-301-1. The Phase 1 study results reinforce our belief that we have created a safe and promising new therapeutic cancer vaccine candidate targeting a specific cancer-relevant marker and overcoming self-tolerance, yet avoiding the serious side effects associated with many other immunotherapeutic cancer drugs,” said Hossein A. Ghanbari, Ph.D., President, Chief Executive Officer and Chief Science Officer, Panacea Pharmaceuticals. “We look forward to presenting more detailed results of this study at a medical conference this year.”
“The vaccine has been well tolerated by patients, with over 90 doses having been administered to the 12 subjects. Based on these results, we are in the planning stages of Phase 2 clinical studies to be initiated in the second half of 2018,” said Steven A. Fuller, Ph.D., Chief Operating Officer.
PAN-301-1 is a de novo-engineered