[Edaily Reporter YU JIN-HEE ] #PenetriumBio is accelerating the development of a treatment for intractable solid tumors as it enters U.S. clinical trials for its new anticancer drug candidate, “Penetrium.”

PenetriumBio announced on the 4th that it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a U.S. Phase 2a clinical trial of Penetrium in patients with recurrent or refractory advanced solid tumors.

This clinical trial tests a novel anticancer drug concept designed to dramatically improve the drug delivery efficiency of existing anticancer agents by addressing “pseudo-resistance”—a phenomenon caused by the physical barrier formed by the tumor microenvironment (TME). It aims to conduct full-scale clinical validation of a “combination therapy” system that simultaneously controls cancer cells (Seed) and the tumor microenvironment (Soil).

Penitrium is a pipeline that has already secured human safety and pharmacokinetic (PK) data through a previously conducted COVID-19 human clinical trial. Consequently, it will proceed directly to the Phase 2a clinical trial—which verifies drug efficacy in accordance with FDA regulations—without undergoing a separate Phase 1 trial for anticancer toxicity evaluation.

The Phase 2a clinical trial will be conducted using a “Master Protocol” approach targeting all types of advanced solid tumors. A total of 18 patients will be recruited from three major medical institutions in the United States to precisely evaluate the anticancer efficacy and safety of the drug when administered in combination with standard therapies.

This IND application was submitted under the leadership of PenetriumBio, the lead applicant. Meanwhile, HYUNDAI BIOSCIENCE CO., LTD. holds the exclusive development and commercialization rights for pancreatic and prostate cancers—two of the solid tumors targeted in this clinical trial—pursuant to a licensing agreement with C&Pharm.

Cho Won-dong, Chairman of PenetriumBio, emphasized, “Based on pre-validated safety in humans, we have entered the FDA Phase 2a clinical trial stage, which will significantly boost development efficiency.” He added, “We will focus our efforts on overcoming ‘pseudo-resistance’—a critical limitation of existing anticancer treatments—and on providing innovative treatment alternatives for patients with intractable cancers.”