PDS Biotechnology Corporation has announced that its Investigational New Drug application for the novel cancer immunotherapy agent PDS0101 has been granted by the FDA, allowing the agent to be evaluated in human patients. PDS0101 is based on the company’s Versamune nanotechnology vaccine platform.
Promising Safety Data
PDS0101 is a first-in-class immunotherapy being developed to treat cancers and diseases caused by infection with the human papillomavirus such as cervical cancer, head and neck cancer, and cervical intraepithelial neoplasia. Frank Bedu-Addo, PhD, President and CEO of PDS Biotechnology, presented the highly promising preclinical efficacy and safety data demonstrating eradication of the tumors without the safety drawbacks typical of the current immunotherapy technologies.
PDS0101 is designed to prime the immune system to recruit cells of the body’s own immune system to specifically recognize, target and kill the cancer cells. The agent is also designed to reduce the population of certain immune suppressive cells which prevent our immune systems from detecting and attacking the cancer cells. “Should the preclinical results be replicated in the clinical setting, this will be a giant leap forward in the development of safe and effective cancer therapies,” said Dr. Bedu-Addo. ■