Dime Bio "2nd Generation PARP Anticancer Drug Phase 1 Clinical Trial Approval"

Bio-venture Dime Bio is commencing clinical trials for new drug candidates targeting solid tumors and brain cancer.

Dime Bio announced on the 12th that the Ministry of Food and Drug Safety has approved the Phase 1 clinical trial plan for the second-generation PARP anticancer drug (PARP-1 selective inhibitor) DM5167.

DM5167 is a PARP-1 selective inhibitor that minimizes hematologic toxicity compared to existing first-generation PARP anticancer drugs. It is a candidate drug for treating solid tumors such as breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer. Notably, DM5167 has excellent brain permeability, making it applicable for brain metastases and brain cancer.

The Phase 1 clinical trial will be conducted orally on approximately 30 to 40 patients with triple-negative breast cancer, ovarian cancer, kidney cancer, pancreatic cancer, head and neck cancer, and brain metastases at three hospitals, including Seoul National University Hospital.

Jungmin Kim, CEO of Dime Bio, said, "We received official approval from the Ministry of Food and Drug Safety without any special modifications to the clinical drug," adding, "Having demonstrated excellent antitumor efficacy in various animal models, we expect safety and efficacy in the Phase 1 clinical trial involving patients."

Dime Bio disclosed nonclinical data of DM5167, which confirmed excellent efficacy and high safety, at the 2023 AACR (American Association for Cancer Research). At that time, CEO Jungmin Kim stated, "PARP inhibitors are expected to grow into a market exceeding 10 trillion KRW by 2026," and added, "The existing first-generation PARP inhibitors have been criticized for toxicity due to PARP-2 inhibition, causing infections, bleeding, or anemia resulting from reductions in bone marrow or blood cells."

The next-generation PARP inhibitor anticancer drugs are second-generation drugs that selectively inhibit only PARP-1. Dime Bio's nonclinical research was jointly conducted with Professor Eunhee Kim's research team at Chungnam National University and Kainos Med.