Boryeong Anticancer Drug Substance 'BR101801' Designated as Orphan Drug in Development Stage

Development of Peripheral T-cell Lymphoma Indication
Designated as Orphan Drug by US FDA in October Last Year

Boryung announced on the 7th that its anticancer drug candidate 'BR101801 (project name BR2002)' was designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety on the 2nd.

Boryeong headquarters building.
Photo by Boryeong

Boryung explained that this designation was made to address the unmet medical needs for the rare cancer 'Peripheral T-Cell Lymphoma (PTCL)'. PTCL is a type of malignant lymphoma characterized by rapid progression and low response rates to treatment. Despite a relapse rate of 68% and high mortality, treatment options have been limited until now.

BR101801 is a first-in-class anticancer drug candidate that simultaneously inhibits three key growth regulators of cancer cells: PI3K gamma (γ), PI3K delta (δ), and DNA-PK. It is being developed for the indication of relapsed or refractory peripheral T-cell lymphoma.

With no established second-line standard treatment for relapsed or refractory PTCL patients to date, Boryung expects the excellent clinical efficacy of BR101801 to serve as a new treatment option. In the Phase 1a clinical trial conducted in 2021, BR101801 demonstrated complete remission in 1 out of 9 PTCL patients and partial remission in 2 patients.

BR101801 is currently undergoing a Phase 1b clinical trial targeting relapsed or refractory patients, which is expected to be completed in the second half of this year. The company anticipates that the domestic orphan drug designation will accelerate its development. Orphan drug designation allows for conditional approval, enabling product approval after completion of Phase 2 clinical trials, thus facilitating early market launch. Previously, BR101801 was also designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in October last year.

Kim Bong-seok, head of Boryung’s New Drug Research Center, stated, "This orphan drug designation reconfirms the urgency of developing treatments for PTCL and the clinical excellence of BR101801. We will do our best to provide hope to PTCL patients suffering from limited treatment options through rapid follow-up clinical trials."

This content was produced with the assistance of AI translation services.