Boryung Pharmaceutical said that the U.S. Food and Drug Administration has approved its phase 1 clinical trial of BR2002, an immunotherapy candidate.
With the approval, the company plans to administer the treatment in 90 patients with non-Hodgkin's lymphoma, while expecting to complete the trials by February 2024.
The company started to develop the candidate after it signed a technology transfer agreement with the Korea Research Institute of Chemical Technology in 2016. The treatment is the world's first drug candidate for non-Hodgkin's lymphoma that inhibits cancer cells' significant growth and regulation factors, phosphoinositide 3-kinase (PI3K) and DNA-dependent protein kinase (DNA-PK).
PI3K is an enzyme that regulates intracellular signaling, cell growth, proliferation, differentiation, migration, and survival.
Notably, overexpression of PI3K in malignant tumors can contribute to the proliferation or metastasis of cancer cells as PI3K regulates the surrounding environment of tumor cells in favor of cancer cell proliferation. DNA-PK is an enzyme that recognizes and repairs DNA damage in cells and is known to help cancer cells survive despite DNA damage.
The company also plans to expand BR2002's indications to solid cancers, starting with blood cancer.
"BR2002 differs from its competitors in that it has higher therapeutic efficacy and safety than existing PI3K inhibitors as it uses a dual-target inhibitory mechanism of PI3K inhibitors and DNA-PK," the company said. "Preclinical findings have confirmed that the treatment had fewer side effects of hepatotoxicity, a disadvantage of existing treatments."
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