[Edaily Reporter YU JIN-HEE ] #HYUNDAI BIOSCIENCE CO., LTD. announced on the 13th that it has begun administering the first dose to a patient in the low-dose group of its Phase 1 clinical trial for “Penitrium,” a new anticancer drug. This marks the start of the world’s first clinical trial to directly verify in humans the “pseudo-resistance” problem—a challenge that the global oncology community has been unable to solve for 80 years.

Led by Professor Chang-wook Jeong of the Department of Urology at Seoul National University Hospital as the principal investigator, the first patient to receive the drug in this trial is a prostate cancer patient whose prostate-specific antigen (PSA) levels have surged and whose response to treatment has waned despite repeated administration of conventional hormone therapy.

This clinical trial will be conducted in three groups: low-dose, medium-dose, and high-dose. Starting with the low-dose group, each patient will receive Penitrium in combination with their existing hormone therapy for three months, during which researchers will monitor “whether the efficacy of the existing hormone therapy is restored” and “safety.”

This clinical trial was designed based on the “Seed & Soil” concept, a classic theory in oncology. Until now, the medical community has focused on directly killing cancer cells (the “seed”). In the early stages of anticancer drug administration, a lethal dose capable of killing cancer cells is delivered; however, as treatment is repeated, a physical barrier forms in the tumor microenvironment (soil). Ultimately, blocked by this barrier, the amount of drug reaching the cancer cells plummets to “sub-lethal doses”—levels insufficient to kill the cells.

C&Pharm, the parent company of HYUNDAI BIOSCIENCE CO., LTD., was the first to elucidate through in vivo experiments on dogs with naturally occurring cancer that “pseudo-resistance”—a phenomenon where drugs lose their efficacy because they are delivered only at sub-lethal doses due to a physical barrier, rather than the cancer cells acquiring resistance on their own—is the true nature of this phenomenon.

Penitrium works to dismantle the physical barrier formed in the tumor microenvironment. As a result, the delivery rate of existing anticancer drugs (such as hormone therapies), which had dropped to sub-lethal levels, is restored to lethal levels, thereby reactivating the previously stalled anticancer efficacy.

If this mechanism is validated in this clinical trial, the need to switch to chemotherapy—which carries side effects—could be delayed or even avoided. If this becomes a reality, it is expected to significantly reduce the risk of cancer metastasis.

In March 2023, NC& Co., Ltd. proactively launched a dedicated intellectual property team, comprising an artificial intelligence (AI) new drug research team and a major law firm. The company has now completed the filing and registration of related patents in 23 countries worldwide, thereby establishing a solid barrier to entry.

HYUNDAI BIOSCIENCE CO., LTD. plans to launch a pancreatic cancer clinical trial as soon as the efficacy of the pseudo-resistance treatment (such as a reduction in prostate-specific antigen levels) is confirmed during the interim analysis of the ongoing Phase 1 prostate cancer trial. In particular, since pancreatic cancer is an area of intense global interest, the company plans to proceed directly to a global Phase 2 clinical trial.

On September 14, PenetriumBio—the company responsible for the industrialization of the Penitrium platform—will host an official event to announce the launch of the global Phase 2 clinical trial.

At this event, the “innovative mechanism of action whereby a single drug simultaneously treats multiple intractable diseases” will be unveiled for the first time worldwide, and the “PenetriumBio Global Phase 2 Clinical Trial Comprehensive Plan (Master Roadmap),” which includes both the prostate cancer and pancreatic cancer Phase 2 clinical trials for which HYUNDAI BIOSCIENCE CO., LTD. has secured exclusive patent rights, will be officially announced.