Bold Therapeutics is a clinical-stage biopharmaceutical company that was founded in 2018 by a team of industry veterans to develop and commercialize novel therapeutics. The company’s lead asset is BOLD-100, a first-in-class metallotherapeutic being developed for the treatment of advanced cancers.
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 anticancer therapies ranging from traditional chemotherapies to targeted therapies to immuno-oncology agents. Learn More
A Phase 2 clinical trial of BOLD-100 in combination with FOLFOX for the treatment of advanced gastrointestinal (bile duct, colon, gastric, and pancreatic) cancers (NCT04421820) is ongoing.
Bold Therapeutics presented initial data from this Phase 2 trial at the 2022 American Society of Cancer Oncology (ASCO) Annual Meeting in June 2022. In addition to demonstrating that BOLD-100 was safe and generally well-tolerated, this data showed remarkable outcomes in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) in combination with FOLFOX – including in patients that had previously failed on FOLFOX alone. Subsequent data has both expanded and strengthened these advantages. Consequently, Bold Therapeutics expects to receive a Breakthrough Therapy Designation in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) and potentially other gastrointestinal cancer indications as well.
A previously completed Phase 1b trial in advanced gastrointestinal cancers indicated that BOLD-100 can be safely combined with FOLFOX chemotherapy, with no new Grade 3 or 4 treatment-emergent adverse events; and patients can safely remain on treatment for an extended number of treatment cycles. Learn More