Bold Therapeutics Unveils Late-Breaking Findings on BOLD-100
On April 28, 2025,
Bold Therapeutics Inc. announced significant late-breaking data regarding its lead drug,
BOLD-100, aimed at mitigating the adverse effects of chemotherapy, specifically
oxaliplatin-induced peripheral neuropathy (OIPN). The company's Sr. Director of Preclinical Development,
Dr. Mark Bazett, will present this pivotal research at the
American Association for Cancer Research (AACR) Annual Meeting 2025 held from April 25-30 in
Chicago, Illinois.
Background on Oxaliplatin and OIPN
Oxaliplatin is widely used in treating metastatic colorectal cancer (mCRC) but is notorious for causing peripheral neuropathy in many patients. Research indicates that up to
85% of those receiving oxaliplatin experience some degree of neuropathy, with
30-50% suffering from chronic symptoms that hamper their quality of life. These symptoms include pain, tingling, and extreme cold sensitivity, primarily affecting patients' hands, feet, and oral cavity. Unfortunately, many oncologists face a challenging decision between effective chemotherapy and maintaining quality of life due to OIPN, as it often results in treatment dose reductions or premature discontinuation.
BOLD-100: A Potential Game-Changer
Given the urgent unmet medical need in managing OIPN, BOLD-100 presents a major breakthrough. Clinical trials have demonstrated that BOLD-100 not only has direct anticancer effects but also significantly reduces the severity and incidence of neuropathy in patients treated with oxaliplatin. This finding positions BOLD-100 on a promising trajectory for further clinical assessments, including a potential Phase 3 trial focusing on first-line mCRC treatment.
Key Findings from the Data Presentation
Dr. Bazett’s presentation, titled "Clinical-stage anticancer agent BOLD-100 demonstrates protective effects against oxaliplatin-induced peripheral neuropathy in an in-vivo rat model," outlines BOLD-100's unique mechanism of action as a selective
GRP78 inhibitor, capable of triggering apoptosis specifically under stress conditions induced by chemotherapy. The Phase 2 data revealed that:
- - BOLD-100 can improve therapeutic outcomes by allowing patients to undergo complete treatment cycles without dose modifications or interruptions.
- - Patients may retain functional independence, with an enhanced quality of life owing to reduced pain and sensory disturbances.
- - Long-term, permanent nerve damage, which frequently develops years after chemotherapy finishes, may be avoidable with BOLD-100.
The Clinical Study Ahead
Currently, Bold Therapeutics is in the process of enrolling
FOLFOX-naïve second-line mCRC patients for a randomized clinical study comparing the standard FOLFOX regimen against FOLFOX combined with BOLD-100. The efficacy, safety, and quality of life outcomes will be meticulously evaluated. Company executives express optimism that this study will illuminate BOLD-100's transformative capabilities in early-line colorectal and biliary tract cancers, alongside other solid tumors.
Future Collaborations and Investor Relations
Bold Therapeutics is enthusiastic about interacting with potential investors, strategic partners, and clinical experts during the AACR event to delve into the promising data and the future of its clinical development plans. The company aims to leverage insights and foster strategic collaborations to enhance therapeutic innovations.
For further inquiries or to schedule meetings with the Bold Therapeutics team, individuals can visit
Bold Therapeutics' website or reach out directly to CEO
E. Russell McAllister.
Conclusion
The strides being made by Bold Therapeutics in oncology therapeutics, especially with BOLD-100, could significantly reshape how patients experience treatment for metastatic colorectal cancer. As they prepare for further studies and collaborations, the medical community remains hopeful for advancements in addressing intolerable OIPN, ensuring enhanced patient care and outcomes.