Boryung has completed patient enrollment for a Phase 2 trial of vosmolisib, a treatment it is developing for a rare blood cancer. The company plans to finish the trial and file for marketing approval in 2028, expanding its business into targeted cancer therapies.
Boryung said on the 19th that it had finished enrolling 44 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) for the Phase 2 study. The milestone comes about seven months after the first patient was dosed in March. The drug is being administered as a monotherapy at 17 medical institutions in South Korea, where researchers are assessing its efficacy and safety.
Vosmolisib is a drug candidate designed to simultaneously inhibit three proteins — PI3K gamma, PI3K delta and DNA-PK — that are involved in the growth and survival of cancer cells and in the repair of damaged DNA. It blocks signals that tumor cells need to grow and survive while also interfering with the repair of damaged DNA.
Peripheral T-cell lymphoma is a rare blood cancer that arises in T cells, a type of immune cell. It generally progresses quickly, and many patients relapse or fail to respond even after initial chemotherapy. Treatment options for relapsed and refractory patients are limited, making the disease one with substantial unmet need for new therapies.
In an earlier Phase 1 trial of vosmolisib, six of the 19 patients evaluated for efficacy showed tumor shrinkage. Of those, as of the latest follow-up assessment, four achieved a complete response, meaning no cancer was detected on examination, and two showed a partial response, with tumors shrinking beyond a defined threshold.
Boryung plans to complete the Phase 2 trial in 2028 after about a year of follow-up observation and then seek conditional approval in South Korea. Vosmolisib has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for certain subtypes of peripheral T-cell lymphoma and has also been designated a development-stage orphan drug in South Korea.
"We will concentrate our capabilities on future trials, carrying the potential confirmed in Phase 1 through to Phase 2 results so that this can become a treatment option for patients with peripheral T-cell lymphoma," Boryung Chief Executive Kim Jung-kyun said. "We will extend the competitiveness we have built in cytotoxic chemotherapy into next-generation areas such as targeted cancer drugs."