Bexion Pharmaceuticals Publishes Phase 1 Data for BXQ-350 in Advanced Tumors

COVINGTON, Ky., Oct. 31, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced the publication of first-in-human data from a Phase 1 study of their experimental therapy, BXQ-350, in Clinical Cancer Research, a journal of the American Association of Clinical Research (AACR). The results indicate that BXQ-350 was well-tolerated with no dose-limiting toxicities noted. This promising therapy is currently being investigated as a first-line treatment for metastatic colorectal cancer (mCRC).

Dr. Robert Wesolowski, Clinical Professor of Internal Medicine at the James Cancer Hospital and the Ohio State University Comprehensive Cancer Center, remarked on the significance of the findings. He highlighted the remarkable outcome where two patients, who began treatment with BXQ-350, have survived without disease progression for seven years. This is particularly noteworthy given the advanced stage of their disease.

The publication outlines adverse event data and efficacy results, showcasing that multiple patients experienced more than six months without disease progression. The study enrolled 86 patients with over 20 different types of tumors, including those with advanced metastatic disease and high-grade glioma. Preliminary pharmacokinetic data revealed that BXQ-350 demonstrated linear exposure, successfully crossed the blood-brain barrier, and accumulated in relevant tissues.

Jim Beach, CEO and President of Bexion Pharmaceuticals, expressed excitement about the publication of their Phase 1 monotherapy data in Clinical Cancer Research. He emphasized that the data demonstrates the safety and tolerability of BXQ-350 in a sizable population suffering from advanced solid tumors and high-grade glioma. Bexion is also currently generating data on the use of BXQ-350 in metastatic colorectal cancer.

The ongoing Phase 1b/2 ASIST study (NCT05322590) is evaluating BXQ-350 in combination with the standard of care for newly diagnosed mCRC patients.

BXQ-350, Bexion's lead drug candidate, is a pioneering biologic therapy containing the multifunctional sphingolipid activator protein, Saposin C, along with a phospholipid. Clinical trials in both adults and pediatric patients with DIPG have shown a strong safety profile for BXQ-350 and demonstrated single-agent activity across various solid tumor types. Additionally, clinical and non-clinical data suggest that BXQ-350 exhibits activity in treating chemotherapy-induced peripheral neuropathy (CIPN), a significant unmet medical need for solid tumor patients undergoing treatment with oxaliplatin and other toxic chemotherapy agents. The therapy also shows potential for treating other neurological diseases.

Bexion Pharmaceuticals is focused on developing a new generation of biologic therapies to treat solid tumor cancers and CIPN, with potential opportunities for expanding their portfolio to include other cancers and broader neuropathic pain indications. The company has generated data in multiple solid tumor classes, such as high-grade gliomas, pediatric brain tumors, and colorectal cancer. Bexion has also completed enrollment for a proof-of-concept trial aimed at treating CIPN. The ongoing Phase 1b/2 study in mCRC is currently enrolling patients in the open-label portion of the study.