Bexion Pharmaceuticals Completes Enrollment in Phase 1b/2 mCRC Study

COVINGTON, Ky., Nov. 18, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm focusing on innovative biologic therapies for solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), has successfully completed enrollment for the open-label segment of its Phase 1b/2 ASIST trial. This study involves BXQ-350 in conjunction with Standard-of-Care (SOC) for initial treatment of metastatic colorectal cancer (mCRC).

Dr. Reema A. Patel, Associate Professor of Medicine at the Markey Cancer Center, University of Kentucky, commented on the milestone, expressing her satisfaction with the significant achievements of her clinical site in the trial. She highlighted BXQ-350's promising mechanism which could benefit patients with metastatic colorectal cancer and those suffering from peripheral neuropathy. Severe neuropathy often forces patients to discontinue chemotherapy for colorectal cancer, but BXQ-350 has shown potential in mitigating neuropathic symptoms. Dr. Patel expressed optimism about the drug's capacity to alleviate or potentially reverse neuropathic pain in affected patients.

The ASIST trial aims to evaluate both the safety and effectiveness of combining BXQ-350 with SOC, specifically the modified FOLFOX7 (mFOLFOX7) regimen and bevacizumab, for patients newly diagnosed with mCRC. An additional focus of the study is to determine if administering BXQ-350 alongside mFOLFOX7 and bevacizumab can reduce CIPN, allowing patients to complete their prescribed treatment courses.

Jim Beach, CEO of Bexion, extended his gratitude to the patients, clinical investigators, and research staff involved in the study. He expressed enthusiasm about moving forward in the clinical development process and anticipated further discussions with the FDA regarding the study's design. Beach also committed to providing updates as they achieve significant milestones in 2025.

BXQ-350 is Bexion's leading drug candidate, a first-in-class biologic that includes the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Previous Phase 1 trials with both adult and pediatric participants have shown BXQ-350 to have a strong safety profile with indications of efficacy as a single agent across various solid tumors. Moreover, clinical and non-clinical data suggest that BXQ-350 might be effective against chemotherapy-induced peripheral neuropathy, addressing a significant unmet medical need for patients treated with oxaliplatin and other chemotoxic agents.

Bexion Pharmaceuticals, dedicated to developing a new class of biologic therapy, aims to treat solid tumors and chemotherapy-induced peripheral neuropathy, with the potential to expand into other cancer types and broader neuropathic pain treatments. The company has acquired promising results across different solid tumors, including colorectal cancer, high-grade gliomas, and pediatric brain tumors. Bexion has also concluded patient enrollment for a proof-of-concept study targeting CIPN.

More details about the clinical trial can be found on clinicaltrials.gov under the identifier NCT05322590.