On October 31, 2024 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), reported 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) (Free AACR Whitepaper) journal (Press release, Bexion, OCT 31, 2024, View Source [SID1234647615]). 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).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. Clinically, two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in solid tumor patients treated with oxaliplatin and other chemo-toxic agents, as well as other neurological diseases.