COVINGTON, KY - Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat advanced solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), announces the publication of first-in-human data from a Phase 1 study of BXQ-350 in Clinical Cancer Research, an American Association of Clinical Research (AACR) journal. The study showed that BXQ-350 was well-tolerated with no dose-limiting toxicities. BXQ-350 is currently being studied for the first line treatment of metastatic colorectal cancer (mCRC).

"These data provide a large body of work on the use of BXQ-350 in patients," said Robert Wesolowski, MD, Clinical Professor of Internal Medicine at the James Cancer hospital and the Ohio State University Comprehensive Cancer Center. "In a population with such advanced disease, the fact that two patients are alive without disease progression seven years after initiating BXQ-350 treatment is remarkable."

The publication highlights adverse event and efficacy data, including multiple patients who survived more than six months without disease progression. The study enrolled 86 patients across over 20 different tumor types, including advanced metastatic disease and high-grade glioma. Preliminary PK data showed that BXQ-350 exhibited linear exposure, crossing the blood–brain barrier and accumulating in relevant tissues.

"We are excited to have our Phase 1 monotherapy data published in Clinical Cancer Research," said Jim Beach, CEO and President of Bexion Pharmaceuticals. "These data demonstrate the safety and tolerability of BXQ-350 in a large population with advanced solid tumor disease and high-grade glioma. We are now generating data on the use of BXQ-350 in metastatic colorectal cancer."

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