- Topline Phase 2b Clinical Data Expected in 1H 2026
- Trial-in-Progress Presentations Scheduled for ESMO and SNO in Fall 2025
- BPM31510 has Received Orphan Drug Designation from the U.S. FDA for the Treatment of GBM
BOSTON, MA., – BPGbio Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced the completion of enrollment in its Phase IIb trial of BPM31510-IV, in combination with Vitamin K1, for patients with newly diagnosed glioblastoma multiforme (GBM).
Following a Phase 1 study in GBM, demonstrating acceptable tolerability and safety, the Phase 2b study enrolled 50 eligible patients aged 18 to 75 across multiple U.S. sites, reflecting strong interest from both patients and investigators in BPM31510. The study is led by Seema Nagpal, MD, Clinical Professor of Neurology and Neurological Sciences, Stanford Medicine.
Trial-in-progress data will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in October, followed by Society of Neuro-Oncology (SNO) Annual Meeting 2025 in November, with topline results from the trial expected in Q2 2026.
The trial (NCT04752813) is a single-arm, multicenter, open-label Phase IIb study designed to evaluate the safety, efficacy and tolerability of adding BPM31510- IV and vitamin K1 delivered in a front-line setting prior to standard of care radiation therapy and temozolomide (TMZ) treatment in patients with newly diagnosed GBM. The primary end point of the trial is progression free survival (PFS) at 6 months.
Glioblastoma remains one of the most aggressive malignancies, with five-year survival below 10%. Nearly all patients relapse following standard-of-care therapy, which includes surgical resection, radiation therapy and/or chemotherapy with TMZ. The poor prognosis highlights the need for novel approaches that address the fundamental biology of the disease. GBM is characterized and driven by certain mitochondrial alterations, most notably metabolic reprogramming (the Warburg effect) and a decreased capacity to undergo apoptosis, leading to its highly aggressive phenotypes.
“Completing enrollment in our Phase 2b GBM trial is a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in GBM, an area of research that has not seen major therapeutic innovation in decades,” said Vijay Modur, MD, Ph.D., Chief Medical Officer, BPGbio. “BPM31510 has shown the ability to prolong survival in animal models and demonstrated activity in both human GBM cell systems and orthotopic glioma models. These findings provide strong scientific rationale as we move forward in evaluating its potential in this devastating disease.”
BPM31510 is a ubidecarenone (CoQ10) containing nanoliposome dispersion positioned to target the mitochondrial tumor microenvironment (TME) to increase ROS and restore the apoptotic potential in GBM. The nanotechnology is designed to deliver supraphysiological levels of oxidized CoQ10 directly to the inner mitochondrial membrane, which can trigger programmed cell death pathways and reverse Warburg-like metabolic phenotypes in tumor cells. BPGbio employed the full power of its biology-first AI platform, the NAi Interrogative BiologyÒ platform to unravel the molecular mechanism of action of BPM31510, assess clinical safety and toxicity signals, and guide clinical development of BPM 31510 for GBM.
“We are grateful to the patients and families who have participated in our clinical trial,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “This milestone represents not just the completion of enrollment, but real progress in advancing a therapy designed to reprogram tumor metabolism. With upcoming presentations at ESMO and SNO and a topline data readout expected in 2026, we are eager to see how BPM31510 can translate into meaningful benefit for patients with GBM.”
Contact: media@bpgbio.com
