Penetrium BioScience has initiated its first global clinical trial for the novel drug candidate Penetrium, launching a Phase 2 study in the U.S.
Industry sources reported on Monday that Penetrium is being developed as a candidate drug that targets the tumor microenvironment surrounding cancer cells. In April, Penetrium BioScience presented guidelines for U.S. Phase 2 clinical trials at the American Association for Cancer Research (AACR) annual meeting, highlighting the drug’s potential across various cancer types and targeted therapies.
Subsequently, the company collaborated with Professor Sandip Patel and Professor Gary S. Firestein from the University of California, San Diego to review Penetrium’s preclinical data. This process led to the finalization of a revised clinical plan that now includes combination therapy with immunotherapy.
The revised clinical plan’s core strength lies in how the two immune cell-targeting drugs complement each other. While existing immunotherapies aim to reinvigorate immune cells suppressed by cancer, Penetrium works to break down barriers that prevent these immune cells from infiltrating tumors effectively.
Penetrium BioScience’s decision to bypass Phase 1 and move directly to Phase 2 trials in the U.S. is based on the extensive safety data already available from human administration of the same formulation as Penetrium.
Given that a drug with an identical formulation has already demonstrated safety in humans for infectious diseases, the cancer clinical trial design could significantly shorten the initial safety verification stage. Meanwhile, a Phase 1 clinical trial for cancer indications is currently underway in South Korea.
Jo Won-dong, Chairman of Penetrium BioScience, emphasized that while immunotherapies have revolutionized cancer treatment over the past decade, many patients still can’t benefit due to barriers surrounding cancer cells. If Penetrium can break through these barriers, immunotherapies could reach a broader patient population. The synergy between these two immune cell-based treatments could usher in the next era of cancer immunotherapy.