Panacea Pharmaceuticals Initiates Phase I Study of First-in-Class Cancer Vaccine Therapy Candidate in Patients with Persistent Prostate Cancer
First Patient Dosed in Four-Center Clinical Trial
Company Research Focused on Range of Cancers through Novel,
HAAH-Based Diagnostics & Targeted Active Immunotherapy
GAITHERSBURG, Md., Jan. 17, 2017 – Panacea Pharmaceuticals, a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs, announced today that the first patient has been enrolled and dosed in the open-label, parallel designed, multi-center Phase I clinical trial of PAN-301-1 for the treatment of persistent prostate cancer to assess safety and immunogenicity. Clinical sites for the PAN-301-1 trial are located in Alabama, California, Nebraska and South Carolina and the trial is managed by Accelovance, Inc.
PAN-301-1, a novel, HAAH-directed nanoparticle immunotherapy vaccine candidate, functions as an immune stimulator nanoparticle with hundreds of copies of an HAAH fragment on the surface of the nanoparticle. This vaccine is highly immunogenic and produces an HAAH-specific antibody response and significantly stimulates immune cells to target HAAH.
HAAH, human aspartyl (asparaginyl) β-hydroxylase (HAAH) or aspartate β-hydroxylase (ASPH), 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. However, in adults, expression of HAAH is uniquely associated with cancer and is related to cancer cell growth, cell motility and invasiveness. In cancer cells, HAAH is only expressed on the surface of the cells and has been detected in more than 20 different types of cancer. HAAH expression levels are 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.
“Based on data from the American Cancer Society, there are more than 160,000 cases of prostate cancer anticipated in 2017 and approximately 30 percent of men treated will relapse after five years, with limited treatment options for patients living with persistent prostate cancer,” said Luke Nordquist, M.D., GU Research Network in Omaha, Neb. and Lead Principal Investigator for the study. “HAAH provides a new potential treatment pathway for patients living with persistent prostate cancer, and with the enrollment of the first patient at our center, we are eager to understand the safety and immunogenicity for PAN-301-1 to address this unmet medical need in cancer diagnosis and treatment.”
In the Phase I trial, PAN-301-1 will be administered through intradermal injection in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose-escalation schema every 21 days to establish the recommended Phase II dose, with an opportunity to extend the study at the same dose. Approximately 18 patients will be enrolled and studied.
“At Panacea, we have created a promising new vaccine therapy drug candidate that targets a specific and novel cancer-relevant marker, overcoming self-tolerance, yet avoiding autoimmune-like side effects of check-point inhibitors throughout our pre-clinical studies,” said Hossein A. Ghanbari, Ph.D., President, Chief Executive Officer and Chief Science Officer, Panacea Pharmaceuticals. “The initiation of the Phase I PAN-301-1 serves as a starting point for utilizing HAAH in treatment to prevent the recurrence of cancer. We are excited to explore this new targeted biological pathway in cancer.”
In animal models of cancer using immune competent mice and rats, which have an HAAH sequence and expression similar to humans, the PAN-301-1 HAAH vaccine has significantly inhibited tumor growth and metastasis, and has enhanced survival, compared to non-treated animals. The vaccine has also been demonstrated as safe in a pre-clinical, multiple-dose toxicology study, which contrasts with the significant side effects that are present in current cancer therapies.
PAN-301-1 is a de novo-engineered vaccine candidate that functions as an immune stimulator nanoparticle with hundreds of copies of an HAAH fragment on the surface of the nanoparticle. This vaccine is highly immunogenic and produces an HAAH-specific antibody response and significantly stimulates immune cells to target HAAH. The vaccine is delivered through intradermal injection using the 3M Drug Delivery Systems’ hollow microstructured transdermal system (hMTS). The candidate 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.
PAN-301-1 is designed to overcome self-tolerance by altering the presentation of the antigen and by providing an immunostimulant. The nanoparticle, a neutralized bacteriophage, is easy to produce and is generally regarded as safe. The nanoparticle vaccine also contains DNA fragments that present the phage CpG motif to activate the MHC class II pathway. The vaccine has been engineered and manufactured in-house to meet FDA requirements for human use.
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. The company has late-nonclinical stage projects in serodiagnosis of cancer, immuno-imaging of cancer, monoclonal antibody-based immunotherapy of cancer and neuroprotection, specifically in prevention of chemotherapy-induced cognitive impairment and peripheral neuropathy.
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.