Early Clinical Trial of Prostate Cancer Vaccine Commences

Pancea Pharmaceuticals recently announced the initiation of a new phase 1 clinical trial of PAN-301-1 for the treatment of persistent prostate cancer.

PAN-301-1 is an HAAH-directed nanoparticle immunotherapy vaccine candidate for the treatment of patients with prostate cancer. The first patient was enrolled and dosed in the open-label clinical trial, which will evaluate the safety and immunogenicity of the vaccine candidate, according to a press release from Pancea.

The vaccine stimulates the immune system by delivering nanoparticles that contain hundreds of copies of HAAH fragments on their surfaces.

HAAH, human aspartyl (asparaginyl) β-hydroxylase, is an enzyme expressed in fetal development, and is involved with cell growth, movement, and cell interactions in tissue formation, according to the press release. After birth, the gene is essentially turned off.

HAAH expression in adults is associated with cancer cell growth, motility, and invasiveness. The expression of this gene has been seen in more than 20 types of cancers, and is present on the surface of cancer cells.

Normal cells that become transfected with the gene act like cancer cells, and when the gene is inhibited in cancer cells, they behave like normal cells, according to the press release.

“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 lead principal investigator Luke Nordquist, MD. “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 new clinical trial, patients will receive the PAN-301-1 injection through intradermal injections. The investigators will use a fixed-dose escalation schema every 21 days to determine the recommended dose to be used in further studies. Pancea plans to enroll 18 patients with biochemically relapsed prostate cancer in the phase 1 trial.

The vaccine was shown to be highly immunogeneic and elicits an HAAH-specific antibody response, and stimulates immune cells to target the enzyme, Pancea reported in the press release. In animal models, PAN-301-1 has demonstrated the ability to inhibit tumor growth and metastasis, while improving survival.

The vaccine has also demonstrated safety in pre-clinical studies, which is not always a benefit seen in cancer treatments, since some drugs have significant adverse events associated with use.

PAN-301-1 is designed to overcome self-tolerance by changing the presentation of the antigen, and providing the body with an immunostimulant, according to Pancea. The nanoparticle is a neutralized bacteriophage that is easy to manufacture.

“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, PhD, president, chief executive officer and chief science officer at 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.”