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 vaccine candidate that functions as an immune stimulating nanoparticle with hundreds of copies of an HAAH fragment on the surface of the nanoparticle. HAAH is an enzyme that is normally expressed in fetal development, where it plays a role in cell growth, movement and cell-cell interaction in tissues during formation. At the time of birth, the gene is silenced. Expression of HAAH is uniquely upregulated in cancer and is related to cancer cell growth, cell motility and invasiveness. HAAH is only expressed on the surface of cancer cells and has been detected in more than 20 different types of cancer. HAAH expression level is inversely correlated with disease prognosis. When normal cells are transfected with the HAAH gene, they behave like cancer cells and when HAAH is inhibited in cancer cells, they behave like normal cells.
PAN-301-1 is designed to overcome self-tolerance by altering the presentation of the antigen and by providing an immunostimulant. The nanoparticle, neutralized bacteriophage, is easy to manufacture and deliver to the patient. The nanoparticle vaccine also contains DNA fragments that present the phage CpG motif to activate the MHC class II pathway.
The vaccine is delivered through intradermal injection using the 3M Drug Delivery Systems' hollow microstructured transdermal system (hMTS). The vaccine is delivered as a small-volume, quick, virtually painless injection via the hMTS, not requiring time-consuming and uncomfortable infusions, greatly facilitating the ease of use and patient acceptance.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs and is headquartered in Gaithersburg, Md. Panacea has late-nonclinical stage projects in serodiagnosis of cancer, immuno-imaging of cancer, fully human monoclonal antibody-based immunotherapy of cancer (antibody-drug conjugates, radioimmunotherapy and naked antibody) as well as neuroprotection, specifically in prevention of chemotherapy-induced cognitive impairment and peripheral neuropathy. The company has exhaustive patent protection for its drug target and drug entities.
Forward Looking Statements Disclosure
This release contains "forward-looking statements." Forward-looking statements can be identified by words such as "anticipates," "intends," "plans," "seeks," "believes," "estimates," "expects" and similar references to future periods. Forward-looking statements include, but are not limited to, statements we make regarding our expectations concerning the clinical study discussed in this release and the clinical outcomes we anticipate through use of our technologies as discussed in this release.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ from those contemplated by the forward-looking statements in this release and such differences may be substantial and material. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include scientific uncertainty, risks and defects in the manufacturing or administration of our products, inability to recruit sufficient patients for ongoing clinical studies, reports of adverse or unanticipated outcomes in these clinical studies, development of competing products, technologies, or services, and changes in economic and regulatory conditions.
Any forward-looking statement made by us in this release speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Steven Fuller, COO
Panacea Pharmaceuticals, Inc.
SOURCE Panacea Pharmaceuticals, Inc.