Boryung Pharmaceutical Co. announced on Aug. 27 that it has received approval for Phase 1 clinical studies on its anti-cancer therapy “BR2002” from the U.S. Food and Drug Administration (FDA). The Phase 1 clinical trial will be conducted on 90 patients with non-Hodgkin's lymphoma tumors. It is due to be completed in February 2024.
BR2002 represents the company’s efforts to push into the global anti-cancer treatment market. The therapy was initially developed by Korea Research Institute of Chemical Technology (KRICT), which transferred its technologies to Boryung Pharmaceutical in 2016. It is the world’s first non-Hodgkin's lymphoma treatment that hinders “PI3K” and “DNA-PK,” major growth regulators of cancer cells, at the same time.
Malignant lymphoma is divided into two main types – Hodgkin lymphoma, also known as Hodgkin disease, and non-Hodgkin's lymphoma. The most common one is non-Hodgkin's lymphoma, a lymphoproliferative disorder where lymphoma stems from B lymphocytes, T lymphocytes and natural killer cells. Currently, 4,300 people are diagnosed with non-Hodgkin's lymphoma in South Korea and 510,000 around the world every year, according to statistics from the National Cancer Information Center in 2015 and the World Health Organization in 2018.
The global malignant lymphoma market is worth 40 trillion won (US$32.95 billion) and the non-Hodgkin's lymphoma treatment market is expected to grow to US$9.20 billion (10 trillion won) in 2020.
Boryung Pharmaceutical is also planning to make BR2002 efficacious for solid tumors, which are cancers that occur in the organs within the body.
Until now, there are only three licensed PI3K inhibitors, including U.S.-based Gilead Sciences' Zydelig, Verastem’s Copiktra and Bayer AG’s Aliqopa. These medications received U.S. FDA approval for the treatments for relapsed chronic lymphocytic leukemia, relapsed follicular lymphoma and relapsed small lymphocytic lymphoma. However, there are no licensed DNA-PK inhibitors in the market yet.
A Boryung official said, “BR2002 has a higher level of efficacy and safety than existing PI3K inhibitors and it is distinguished among its competitors because it is both a PI3K inhibitor and a double targeted mechanism-based DNA-PK inhibitor. In fact, the drug has been proved to have less side effects of hepatotoxicity, which was one of the demerits of existing treatments, in all clinical trials.”