Exercising the option

VANCOUVER, B.C.—Bold Therapeutics announced today that the company has executed an option agreement with Hana Pharm Co. Ltd. for exclusive rights to BOLD-100 in South Korea. BOLD-100 is a first-in-class anti-resistance ruthenium-based small molecule drug which selectively inhibits stress-induced upregulation of GRP78 — an important resistance, survival and proliferation pathway common across cancers.

BOLD-100 is an anti-resistance therapy, meant to work in combination with other existing anti-cancer therapies. According to Bold Therapeutics’ website, “BOLD-100 has demonstrated synergy in established preclinical models in combination with a wide variety of anti-cancer therapies, including both traditional chemotherapies and targeted therapies [and] tyrosine kinase inhibitors and checkpoint inhibitors. BOLD-100 successfully completed a Phase 1 monotherapy dose escalation study and was subsequently granted an Orphan Drug Designation in pancreatic cancer.”

“I am pleased to partner with Hana Pharm, one of the fastest growing and most successful pharmaceutical companies in South Korea, on the development of BOLD-100. This collaboration allows us to leverage Hana Pharm’s significant oncology development and commercialization expertise in Korea to accelerate development of BOLD-100,” said E. Russell McAllister, CEO of Bold Therapeutics. “Under this collaboration, we expect to both add clinical sites in South Korea to our planned Phase 1b/2a adaptive trial by early 2021, potentially accelerating enrollment and the resulting timing of interim efficacy data … the first of many win-win partnerships.”

Under the terms of the agreement, Bold Therapeutics and Hana Pharm will collaborate on Bold Therapeutics’ upcoming Phase 1b/2a adaptive trial in gastric, pancreatic, colorectal and bile duct (cholangiocarcinoma) cancers. The companies also plan to explore the potential development of BOLD-100 in TNBC.

“Hana Pharm previously identified oncology as an area of strategic opportunity, and is focusing on identifying and licensing novel drugs for oncology indications with significant unmet medical needs,” noted Dr. Younha Lee, CEO of Hana Pharm. “Bold Therapeutics’ BOLD-100 is a first-in-class compound that appears to broadly defeat resistance, a premise supported by a robust combination of nonclinical efficacy and clinical safety data. Therefore, we are thrilled and inspired by the opportunity to collaborate with Bold Therapeutics in the development of BOLD-100 as it moves into proof-of-concept studies and beyond.”

“The quality of clinical data from South Korea is viewed favorably throughout the world. This promising partnership speaks to BOLD-100’s remarkable potential and allows us to generate data in an Asian population earlier than would otherwise have been possible. I look forward to working with our new clinical and regulatory colleagues at Hana Pharm in the coming weeks,” added Jim Pankovich, EVP of Clinical Development at Bold Therapeutics.