Bold Therapeutics is a clinical-stage biopharmaceutical company that was founded in 2018 by a team of industry veterans to develop and commercialize novel metallotherapeutics. At Bold Therapeutics we leverage the unique Mechanism of Action and complex chemistry of metal-based complexes to address the unmet needs for the treatment of advanced cancers.
Metallotherapeutics, or metal-based small molecule therapeutics, are unquestionably some of the most effective anticancer agents available. Despite significant advances in biologic and gene therapies, metallotherapeutics like cisplatin, carboplatin and oxaliplatin continue to be included in the WHO Model List of Essential Medicines, and even today a majority of cancer patients receive a metallotherapeutic at some point in the course of their treatment.
Bold Therapeutics looks to leverage the extensive clinical benefit of metal-based therapeutics to create a robust pipeline of the next-generation of metallotherapeutics to treat the unmet needs in advanced cancers. Bold’s lead candidate, BOLD-100, has a unique mechanism-of-action with evident therapeutic potential in colorectal, bile duct, gastric and other gastrointestinal cancers. BOLD-100 causes DNA damage and cell cycle arrest -- but it also alters the unfolded protein response (UPR) through selective GRP78 inhibition, a mechanism that appears difficult to evade and particularly effective against heavily mutated or resistant cancer cell lines. As a result, extensive preclinical and, more recently, clinical data suggests that BOLD-100 could enhance the effectiveness of a wide range of existing cancer therapies and significantly improve patient outcomes. Building on promising efficacy and safety results from a Phase 2 clinical trial of BOLD-100 in late-line metastatic colorectal cancer (mCRC), gastric cancer (GC), and bile duct cancer (BTC), Bold Therapeutics is advancing to a first-line Phase 2 trial in mCRC, a pivotal Phase 3 trial in fourth-line mCRC, and a second-line Phase 2 trial in BTC. BOLD-100 has already received Orphan Drug Designations (ODDs) in gastric and pancreatic cancers, and will pursue Breakthrough Therapy Designation (BTD) in gastrointestinal cancer indications in the future.
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Realizing the untapped potential of metallotherapeutics and leveraging unparalleled development and manufacturing expertise in metallotherapeutics, Bold Therapeutics is focused on discovering and developing the next generation of metallotherapeutics with novel mechanisms-of-action, broad therapeutic potential, high potency, and low systemic toxicity.