Bexion Pharmaceuticals, Inc. Announces Publication of Pediatric Phase 1 (KOURAGE) Results
Study achieved planned maximum dose of BXQ-350 with strong safety profile FOR IMMEDIATE RELEASE Covington, KY, February 23, 2022 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, announced today results from their clinical trial entitled, “An open-label multi-center phase 1 safety study of BXQ-350 in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors (KOURAGE)” have been published in [...]
Cincinnati Enquirer: 8 Cincinnati biotech companies with big steps to watch in 2020
Excerpt: Cincinnati has become a nurturing place for bright ideas in biotechnology, and 2020 could bring big advancements. The Cincinnati USA Regional Chamber of Commerce estimates the industry contributes more than $3 billion to the area economy. Nearly 800 locations employ more than 13,000 workers who are making average salaries of about $100,000 a year. In alphabetical order, here are eight Cincinnati biotechs aiming for milestones in 2020. Bexion Pharmaceuticals [...]
Absence of Indicators of Hypercoagulability and Anti-phospholipid Syndrome in BXQ-350 First in Human Study.
Allometric Scaling of Preclinical Pharmacokinetic and Toxicokinetic Parameters to Predict Clinical Pharmacokinetics of BXQ-350 Saposin C Protein-Phosphatidylserine Nanovesicles.
Combined Effect of Gemcitabine (GEM) and SapC-DOPS Nanovesicles on Pancreatic Ductal Adenocarcinoma (PDAC) in Mice.
Safety and Pharmacokinetics of BXQ-350 in a Phase 1a and 1b Trial of Solid Tumors and High-grade Glioma.
Trial in Progress: A Phase 1 Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of BXQ-350 in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)with H3K27M alteration
A Pediatric and Young Adult Phase I Dose Escalation Safety Study of BXQ-350 for Refractory Solid and Central Nervous System Tumors
BXQ-350 targets to the lysosome and kills glioblastoma (GBM) cells via activation of apoptotic caspases in vitro.
Outcomes of High-Grade Glioma Patients in a Phase 1 Trial of BXQ-350, Cancer-selective SapC-DOPS Nanovesicles
Phase 1 Patient 1080-001:
Long Lasting Benefit in mCRC >5 years
PET/CT before BXQ-350
PET/CT after 18 months on BXQ-350
- 40-yr old female with stage 4 metastatic colorectal carcinoma
- Diagnosed in Nov 2015, previously treated with surgery, chemotherapy and radiation (>3 lines)
- Rapid progression (5 months) prior to starting BXQ-350
- Target lesion (1.5 cm) remained unchanged per Recist
- Still Stable Disease over 5 years on study
Phase 1 Patient 1008-701:
Long Lasting Benefit in GBM > 5 years!
- Red Arrows indicate the initial target lesion that decreased in size while on study
- Blue Arrows indicate new area of enhancement
- Note: Surgery in May, 2018 revealed significant treatment effect with only trace tumor cells present. As of September, 2019 patient continues on study having completed 3 years in the trial.
Case Data: Glioblastoma (GBM)
- Axial T1-post contrast (Ax SE T1 POST FC) 1.5T MRI of the brain of a 64-yr old male patient with glioblastoma (GBM) treated with BXQ-350. GBM was first diagnosed in 2013 and previously treated with surgery, chemotherapy and radiation. Measurable lesion reduction over time is apparent in the anterior corpus callosum and frontal lobe, with those bordering the ventricle.
Phase 1 Patient 1075-213:
Partial Response in Glioblastoma (-74%)
- 65-yr old female with rGBM
- GBM diagnosed in March 2017 (stage IV) previously treated with surgery, chemotherapy and radiation
- Rapid progression (2M) prior to starting BXQ-350 in May 2018
- 1 target lesion (L parietal) 1.4 cm at Screening down to 0.36 cm at Day 56 (-74%)
- Progressed after 948 days on BXQ-350