PenetriumBioScience is moving to enter a U.S. Phase 2a clinical trial of its anticancer drug candidate Penetrium.
According to a filing with the Financial Supervisory Service’s electronic disclosure system on Aug. 5, PenetriumBioScience submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial of Penetrium in patients with recurrent or refractory advanced solid tumors.
The trial aims to overcome so-called “pseudo-resistance,” in which anticancer drugs fail to reach cancer cells in sufficient concentrations because of the tumor microenvironment (TME), thereby enhancing the therapeutic effects of existing anticancer treatments. The company plans to evaluate a combination treatment strategy that simultaneously targets cancer cells and the tumor microenvironment.
The tumor microenvironment is a complex environment surrounding cancer cells that includes blood vessels, immune cells and connective tissue. It has recently emerged as a key target in the development of next-generation cancer treatments.
Penetrium will enter Phase 2a without a separate Phase 1 cancer trial under FDA regulations, as the company has already obtained human safety and pharmacokinetic (PK) data through previous clinical trials for COVID-19.
The trial will enroll 18 patients with advanced solid tumors at three U.S. medical institutions and evaluate the efficacy and safety of Penetrium in combination with standard-of-care treatments. A “master protocol” design covering multiple types of solid tumors will be used.
Meanwhile, Hyundai Bioscience holds the exclusive development and commercialization rights for Penetrium in pancreatic and prostate cancer indications under a licensing agreement with C&C Pharm.
Cho Won-dong, chairman of PenetriumBioScience, said, “We will accelerate development so that we can overcome pseudo-resistance, a major limitation of existing cancer treatments, and provide new treatment options for patients with difficult-to-treat cancers.”