Boryung Completes Phase 2 Trial Enrollment

Boryung has completed patient enrollment for Phase 2 clinical trials of 'Bersomolisib (BR101801),' a next-generation anticancer drug candidate that is the world's first to simultaneously inhibit PI3K gamma (γ), PI3K delta (δ), and DNA-PK, substances that cause hematologic malignancies. The company said on Oct. 19 that it had completed enrollment of the target 44 patients about seven months after dosing the first patient in March. The pace is unusually fast given the difficulty of securing eligible patients for clinical trials involving rare blood cancers. The trial is being conducted at 17 institutions in Korea to evaluate the antitumor effect and safety of monotherapy. Bersomolisib is a first-in-class drug that simultaneously targets three pathways involved in cancer cell growth and survival signaling and DNA damage repair. Its generic name combines the first syllable of Boryung, Superior small Molecule, and the suffix lisib used for the PI3K inhibitor class. In the earlier Phase 1 trial, objective responses were observed in six of 19 efficacy-evaluable patients, demonstrating the drug's potential. In particular, four of them showed complete responses, while some patients continued treatment for more than three years, confirming a long-term disease control effect. Bersomolisib has already received orphan drug designation from the U.S. Food and Drug Administration and Korea's Ministry of Food and Drug Safety. In Korea, it has been designated as a rare disease drug at the development stage, allowing the company to apply for conditional approval after completing Phase 2. Boryung plans to complete Phase 2 by 2028 after one year of follow-up observation and obtain marketing approval to accelerate commercialization. Through this trial, Boryung has set a strategy to expand the capabilities it has built in the cytotoxic anticancer drug segment into next-generation areas such as targeted anticancer therapies. If it secures conditional approval, the company expects to establish a bridgehead for a full-scale entry into the anticancer drug market led by global pharmaceutical companies, based on the advantages of early market entry. Kim Jeong-gyun, CEO of Boryung, said, "Bersomolisib is a new drug that embodies Boryung's research and development capabilities, and we will carry the potential confirmed in Phase 1 into Phase 2 results," adding, "We will focus our clinical capabilities so that we can quickly provide a treatment option to patients with peripheral T-cell lymphoma."