On April 30, 2025 Bold Therapeutics Inc., a clinical-stage biopharmaceutical company pioneering novel oncology treatments, reported that its Sr. Director of Preclinical Development, Mark Bazett, PhD, is presenting a late-breaking poster on BOLD-100’s potent neuroprotective properties later today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Bold Therapeutics, APR 30, 2025, View Source [SID1234652397]).
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Session: Late-Breaking Research: Experimental and Molecular Therapeutics 4
Neuropathy Rates from BOLD-100-001 vs. Historical Controls
Neuropathy Rates from BOLD-100-001 vs. Historical Controls
Bold Therapeutics’ Data in a Model of Cold Allodynia
Bold Therapeutics’ Data in a Model of Cold Allodynia
Date & Time: April 30, 2025, from 9:00 AM to 12:00 PM
Location: Poster Section 51, Poster Board #14
Poster Code: #LB432
Poster Title: "Clinical-stage anticancer agent BOLD-100 demonstrates protective effects against oxaliplatin-induced peripheral neuropathy in an in-vivo rat model"
Addressing a Critical Unmet Need: Oxaliplatin-Induced Peripheral Neuropathy
In Bold Therapeutics’ global Phase 1b/2a trial (BOLD-100-001, NCT04421820), patients with advanced gastrointestinal cancers — including colorectal (mCRC), gastric (GC), biliary tract (BTC), and pancreatic cancer (PDAC) — were treated with BOLD-100 in combination with FOLFOX (5-fluorouracil, oxaliplatin, leucovorin). Across 109 patients in six treatment arms, the study showed encouraging efficacy data, which was previously presented at ESMO (Free ESMO Whitepaper) GI and ASCO (Free ASCO Whitepaper) in 2024.
A surprising finding from this trial was a profound reduction in both the frequency and severity of oxaliplatin-induced peripheral neuropathy (OIPN), a relatively common and debilitating side effect of chemotherapy. In each patient cohort, rates of neuropathy were dramatically lower than those typically seen in historical benchmarks for FOLFOX alone:
These results were supported by feedback from trial investigators, many of whom noted the unexpectedly low incidence of neuropathy in their patients treated with BOLD-100 — particularly those who were heavily pretreated and/or receiving FOLFOX again where one would expect both a high incidence and severity of neuropathy.
To better understand this effect, Bold Therapeutics developed a preclinical rat model of cold allodynia, a common symptom of OIPN. Rats were treated with either high or low doses of oxaliplatin and then given BOLD-100 every three days for 17 days. The results confirmed the clinical findings: rats receiving BOLD-100 showed significantly less neuropathic pain. Once treatment with BOLD-100 stopped, neuropathy symptoms rapidly returned, further supporting its protective effect.
These findings prompted further efforts to elucidate BOLD-100’s neuroprotective mechanism and investigation into whether BOLD-100 can prevent or reduce neuropathy from other neuropathy-inducing agents, such as the taxanes. BOLD-100’s unique ability to both directly impact cancer while simultaneously preventing or reducing OIPN could redefine first-line treatment by helping patients:
Improve overall outcomes through direct anti-cancer activity and completing full chemotherapy cycles.
Stay on therapy longer without dose reductions or early discontinuation.
Experience less pain, tingling, and sensory issues that impact daily life.
Avoid long-term nerve damage that can persist long after treatment ends.
Ongoing Clinical Study and Future Outlook
Bold Therapeutics is currently enrolling FOLFOX-naïve second-line mCRC patients in a multinational randomized clinical study comparing FOLFOX vs. FOLFOX + BOLD-100 in various efficacy, safety, and quality-of-life endpoints. Bold Therapeutics anticipates this trial will further demonstrate BOLD-100’s potential as a transformative therapy in early-line colorectal cancer, biliary tract cancer and other solid tumor indications.
Bold Therapeutics invites investors, strategic partners, clinical investigators and key opinion leaders to connect with the team at AACR (Free AACR Whitepaper) to discuss these latest findings, the company’s ongoing clinical development plans, and potential strategic collaborations.