Bold Therapeutics' BOLD-100 is a first-in-class metallotherapeutic with a unique multimodal mechanism-of-action that targets a critical replication and survival pathway common across all cancers. Interim results presented at AACR (April 2023) and ASCO (June 2023) showed robustly positive efficacy and safety results in advanced colorectal, biliary tract and gastric cancer patients. As of an August 31, 2023 data cutoff, data from 36 patients with advanced metastatic colorectal cancer was presented in clinical poster format (abstract #143) entitled "BOLD-100-001 (TRIO039): A Phase 2 Study of BOLD-100 in Combination with FOLFOX in Advanced mCRC Patients Previously Treated with FOLFOX/CAPOX: Efficacy and Safety Analysis." Enrolled patients had a median of 4 [range 2-8] prior therapies including FOLFOX/CAPOX
67% of patients had progressive disease on prior FOLFOX/CAPOX
Median progression-free survival (PFS) was 3.9 months [CI 2.7, 5.7]
Median overall survival (OS) was 9.6 months [CI 6.0, 17]
In 29 evaluable patients for response, the objective response rate (ORR) was 7.0%, with 2 partial responses (PR) and 20 stable diseases (SD) resulting in a disease control rate (DCR) of 76%
BOLD-100 in combination with FOLFOX continued to be well-tolerated, with no new safety signals. For all treated patients, treatment-emergent adverse events (TEAEs) were observed in 33 (92%) of patients, with the most common TEAEs as follows: neutrophil count decreases (all grade 47%, grade ≥3 42%), nausea (42%, grade ≥3 0%), and fatigue (19%, grade ≥3 0%). "Not only are we encouraged with BOLD-100's efficacy, but we are excited about BOLD-100's unexpectedly favorable safety profile, which has allowed patients to remain on treatment considerably longer than originally expected and thus maximizes the impact of the treatment combination," noted Jim Pankovich, EVP of Clinical Development. "More specifically, relatively few patients in our study experienced neurotoxicity, despite all patients having been previously treated with neurotoxicity-inducing oxaliplatin." Phase 2 safety and efficacy results in biliary tract and gastric cancer are currently available under confidentiality and will be presented publicly at a major cancer conference later this year. "Bold Therapeutics was founded in 2018 to improve patient outcomes in some of the most difficult-to-treat cancer indications and has rapidly advanced since then" added E. Russell McAllister, CEO. "We look forward to advancing BOLD-100 into late-stage studies in the near-future, initially targeting a 2027 FDA approval in advanced metastatic colorectal cancer." For more information, please visit the Company's website at https://www.bold-therapeutics.com/
Contact: E. Russell McAllister, CEO