Bold Therapeutics is a clinical-stage biopharma company based in Vancouver, British Columbia founded in 2018 to develop and commercialize BOLD-100, a first-in-class small molecule therapeutic with applications in both oncology (cancer) and infectious disease (COVID-19).
BOLD-100 has a unique multimodal pro-apoptotic mechanism-of-action (MoA). In oncology, BOLD-100 (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 caspase-8 cell death (apoptosis) in both sensitive and resistant cancers. As an antiviral, BOLD-100 interferes with viral replication – and has been shown to be effective at low micromolar concentrations. Importantly, the results from our nonclinical and clinical work to date suggest that BOLD-100 is selective for cancer cells, accomplishing these goals with minimal toxicity.
Based on compelling preclinical and early clinical results, Bold Therapeutics is focusing its clinical development efforts on some of the most challenging indications where existing therapies are largely ineffective, resulting in a significant unmet medical need.
Bold Therapeutics is focused on efficient, early- and mid-stage clinical development. Bold Therapeutics’ management team leverages deep strategic, development and manufacturing expertise to advance compelling but unproven therapeutics into and through Phase 1/2 clinical trials with the goal of licensing these now-proven products to established biopharmaceutical companies. In May 2020, Bold Therapeutics executed an option agreement with Hana Pharm Co of South Korea.
Oncology. Bold Therapeutics is developing BOLD-100 as a novel anti-cancer therapeutic. Bold Therapeutics is currently enrolling patients into a Phase 1/2 clinical study in advanced gastrointestinal cancers (2nd line gastric, pancreatic, colorectal and bile duct cancers) in combination with FOLFOX at six sites in Canada, with additional sites to be added in the United States and South Korea in late 2021 and early 2022. In established preclinical models, BOLD-100 significantly improved outcomes in a wide range of indications in combination with both traditional chemotherapies and targeted therapies. A previously completed Phase 1 monotherapy dose-escalation study showed that BOLD-100 was generally safe and well-tolerated with a safety profile suggesting that it could be combined with other anti-cancer therapies.
Infectious Disease (COVID-19). Bold Therapeutics has collaborated with infectious disease experts across Canada to develop BOLD-100 as a novel broad-spectrum antiviral. Initial results far exceeded expectations, with BOLD-100 demonstrating efficacy against not just SARS-CoV-2 (COVID-19), but a range of other viruses. In December 2020, Bold Therapeutics was one of only four therapeutics companies selected to receive COVID-19 funding and support from the Canadian government through NRC-IRAP. BOLD-100 is currently being tested in animal models of COVID-19 and expects to initiate clinical trials in COVID-19 later in 2021.
Bold Therapeutics' lead development candidate is BOLD-100, a novel first-in-class anti-resistance therapy for the treatment of gastric, pancreatic, colorectal and other cancers in combination with existing anti-cancer therapies. 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 including 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 (ODD) in pancreatic cancer. Bold Therapeutics’ next clinical trial with BOLD-100 has been initiated. This Phase 1b trial will investigate BOLD-100 in combination with FOLFOX in patients with advanced gastric, pancreatic, bile duct and colon cancer. Bold Therapeutics will be starting recruitment of patients at various sites in Canada and the United States shortly.Learn More