NKP-1339

VANCOUVER, BC, April 16, 2026 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company that was founded to develop and commercialize novel metallotherapeutics, has shared new data highlighting the ability of its lead asset, BOLD-100, to demonstrate protective effects against chemotherapy-induced peripheral neuropathy. BOLD-100 is a first-in-class, ruthenium-based anticancer agent in Phase 2 clinical development for advanced gastrointestinal (GI) cancers in combination with the chemotherapy regimen FOLFOX. BOLD-100 plus FOLFOX improves overall survival and progression-free survival in patients, including advanced colon (mCRC), gastric (GC), and bile duct cancers (BTC). While FOLFOX is a standard-of-care therapy for GI cancers, its clinical utility is limited by acute and chronic peripheral neuropathies which present in the majority of patients. Remarkably, in the ongoing Phase 2 development of BOLD-100, significantly lower than expected incidence of oxaliplatin-induced peripheral neuropathy (OIPN) was observed in patients treated with BOLD-100 plus FOLFOX. Compared to FOLFOX alone historical benchmarks, BOLD-100 plus FOLFOX any-grade neuropathy was: Colorectal Cancer; 14% vs 53% benchmark Biliary tract cancer; 35% vs 58% benchmark Gastric Cancer; 19% vs 63% benchmark "These clinical findings are promising given the prevalence of peripheral neuropathy among patients undergoing chemotherapy," said Mark Bazett, PhD, Senior Director of Preclinical Development. "The potential to improve patient outcomes while simultaneously improving quality of life is a key differentiating characteristic of BOLD-100. Our upcoming AACR presentation validates these important results in a range of preclinical models, and provides mechanistic understanding." Bold Therapeutics will be attending the American Association for Cancer Research (AACR) Annual meeting later this month in San Diego from April 17-22, where they will present advanced in vivo and in vitro preclinical modelling of BOLD-100's neuroprotection, along with mechanism of action data. Abstract Title: Clinical-stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy Session Time: April 21, 2:00 PM - 5:00 PM Location: Poster Section 14; Poster Board 11 Presentation Number: 5753 Abstract link: Bold Therapeutics is currently advancing BOLD-100 through a global Phase 2 randomized controlled trial across sites in Canada, European Union, and South Korea. This trial is investigating BOLD-100's anticancer efficacy but also includes important quality of life questionnaires focused on its neuroprotective potential. Please visit ClinicalTrials.gov for more information (NCT04421820). For more information or for interest in investing, please visit the Company's website at Contact: Jim Pankovich, EVP (604)262-9899 [email protected] SOURCE Bold Therapeutics Inc. 21% more press release views with Request a Demo

Bold Therapeutics reported that BOLD-100, its ruthenium-based anticancer agent, was associated with substantially lower rates of oxaliplatin-induced peripheral neuropathy in patients receiving FOLFOX chemotherapy across three advanced gastrointestinal cancer types, adding a potential tolerability dimension to a drug already in Phase II development for efficacy. The BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours trial (NCT04421820) is a global Phase I/II randomized controlled study enrolling patients with advanced gastrointestinal cancers across sites in Canada, the EU, and South Korea. Compared to historical benchmarks for FOLFOX alone, any-grade neuropathy rates in patients receiving BOLD-100 plus FOLFOX were 14% versus a 53% benchmark in metastatic colorectal cancer, 19% versus 63% in gastric cancer, and 35% versus 58% in biliary tract cancer. The company did not disclose patient numbers for each subgroup, and the comparisons are against historical controls rather than a concurrent randomized arm, which limits interpretation. No formal safety analysis was presented alongside these figures. The neuropathy data are being presented at the American Association for Cancer Research Annual Meeting on April 21 alongside in vivo and in vitro preclinical modelling intended to provide mechanistic context for the observed clinical signal. BOLD-100 is a first-in-class ruthenium-based small molecule, distinct from platinum-based agents such as oxaliplatin. Trial evidence links it to downregulation of GRP78, a protein associated with endoplasmic reticulum stress responses in tumor cells, though that target assignment remains incompletely validated. Oxaliplatin, the platinum component of FOLFOX, causes peripheral neuropathy through DNA adduct formation and crosslinking; the mechanism by which a ruthenium compound might attenuate this toxicity is not established from the press release alone and will be addressed in the AACR preclinical presentation. Cross-trial comparisons are limited by differences in patient populations, follow-up duration, and grading criteria, and the neuropathy figures reported here should not be interpreted as equivalent to prospectively powered endpoint data. The ongoing Phase II randomized trial includes quality-of-life questionnaires focused on neuroprotective outcomes alongside its primary anticancer endpoints, which suggests the company is building a prospective dataset to support the clinical observation reported here. Full data from that trial, including formal efficacy readouts and patient-reported neuropathy assessments, have not yet been disclosed. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website