Bexion Pharmaceuticals, Inc. Announces Publication of Phase 1 Data for BXQ-350 in Advanced Solid Tumors

COVINGTON, Ky., Oct. 31, 2024 /PRNewswire/ -- 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), today announced 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.

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.

About Bexion Pharmaceuticals
Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion has generated data in multiple classes of solid tumors, including high-grade gliomas, pediatric brain tumors, and colorectal cancer. The Company has also competed enrollment in a proof-of-concept trial for the treatment of CIPN. The Phase 1b/2 study in mCRC is enrolling patients in the open label portion of the study.

Investor Contact:
William Windham
Solebury Strategic Communications
646-378-2946
[email protected]

Media Contact:
Joyce LaViscount
Bexion Pharmaceuticals
859-446-7386
[email protected]

SOURCE Bexion Pharmaceuticals, Inc.