Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, is pleased to announce an extension of the option agreement with an undisclosed publicly traded South Korean biopharmaceutical company, originally executed in May 2020, for development and commercialization rights to BOLD-100 in South Korea. The extension is expected to further solidify cooperation between these companies, as well as support the addition of five clinical trial sites in South Korea: Seoul National University Hospital (PI: Do-Youn Oh); Samsung Medical Center (PI: Joon Oh Park); Severance Hospital (PI: Sun Young Rha); National Cancer Center (PI: Yongjun Cha); and Kangbuk Samsung Hospital (KBSMC) (PI: Dong-Hoe Koo).
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Bold Therapeutics’ BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anti-cancer therapies ranging from traditional chemotherapies to targeted therapies to immuno-oncology agents. BOLD-100 has been granted Orphan Drug Designations (ODDs) by the FDA in both gastric (stomach) and pancreatic cancers, and Bold Therapeutics expects to receive one or more Breakthrough Therapy Designations (BTDs) for BOLD-100 in 2022. Preclinical experiments have repeatedly shown that BOLD-100 improves outcomes in combination with a wide range of existing anti-cancer therapies, with particular synergy evident in drug-resistant cell lines.
“As our partner is one of the fastest growing and most respected pharmaceutical companies in South Korea, we are honored to extend this option agreement that allows us to further leverage their substantial expertise in oncology development,” said E. Russell McAllister, CEO of Bold Therapeutics. “We expect to complete our Phase 1b trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers imminently and immediately transition into a Phase 2a study at six sites in Canada, two sites in the U.S., and now five sites in South Korea. We look forward to continuing to work with our partner’s team to advance this revolutionary cancer therapy.”