PDS Biotechnology Corporation Products (Page 2)
Cancers caused by infectious agents
About 20% of the world’s incidence of cancer is caused by infectious agents. Examples are cervical cancer and head and neck cancer caused by infection with the human papilloma virus (HPV) and hepatoma caused by infection with the hepatitis B virus.
PDS0101 – Treatment of HPV-Related Cancers
PDS’s lead product is being developed to prevent and to treat HPV infections and diseases caused by HPV infection. HPV is by far the most prevalent sexually transmitted agent worldwide. Cervical cancer is the second leading cause of female mortality behind breast cancer, and head and neck cancers are the sixth most common cancer, with over 50% of oropharyngeal cancers and tonsillar carcinomas estimated to be HPV-associated in developed Western countries. Over 400 million people are infected with the HPV virus, and there are about 500,000 cases of cervical cancer a year, resulting in over 250,000 deaths a year. No cures exist for these diseases and infections.
Dr. Harald zur Hausen a German physician and scientist at the German Cancer Research Center in Heidelberg was awarded the 2008 Nobel Prize in Medicine for discovering the human papilloma viruses that cause cervical cancer.
PDS0101 is in preclinical development. Pre-IND toxicology and pharmacology studies, including physical and chemical analyses of the product, have been conducted by the US National Cancer Institute’s Nanotechnology Characterization Laboratory. Superior efficacy has been demonstrated in animal model studies of HPV-cancer and also in human model studies of the disease. A recently completed GLP toxicology study in rodents and non-human primates demonstrated a very safe profile with no toxic effects observed even at the highest studied doses.
The picture above shows tumor regression in mice with a single injection of PDS0101 compared to the free HPV antigen.
Infiltration of CD4+ T-cells (helper T-cells) was also demonstrated in the study (not shown). Tumor antigen specific CD8+ T-cells, also known as cytotoxic T-cells or killer T-cells, are effector cells of the immune system responsible for detecting and destroying cells infected by pathogenic microorganisms or cancer cells. The Versamune™ technology promotes the expansion of populations of tumor-specific killer T-cells that can be mobilized to destroy cancer cells caused by HPV infection. The infiltration of these cancer-specific killer T-cells (green spots) into the tumor microenvironment (blue) following a single injection of PDS0101 is shown below.
The recruitment of activated populations of disease-specific killer T-cells to the tumor microenvironment leads to cancer cell death and tumor destruction. The initiation of apoptosis (cancer cell death, brown staining) in a cervical cancer tumor resulting from a single injection of PDS0101 is shown below.
