BPGbio Presents Phase 2 Glioblastoma Data on BPM31510 at ESMO 2025

• BPGbio has completed phase 2b enrollment in late August this year for treatment of GBM with BPM31510
• Data further validate the MOA of BPM31510’s direct targeting of mitochondrial redox machinery to re-potentiate apoptosis in highly aggressive tumor type

BOSTON, Oct. 16, 2025 (GLOBE NEWSWIRE) -- BPGbio Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced that it will present two posters on its lead investigational drug BPM31510 for Glioblastoma (GBM) in collaboration with Stanford University School of Medicine and other major US cancer centers at the European Society for Medical Oncology (ESMO) Congress 2025 held from October 17 – 20 in Berlin, Germany. BPGbio has completed the phase 2b enrollment of GBM trial late August this year.

Together, the presentations highlight new insights into the mitochondrial-targeting investigational therapy BPM31510, including both biomarker-driven pharmacodynamic analyses in patients with recurrent GBM and interim progress from an ongoing Phase 2 trial in newly diagnosed GBM patients.

“We are excited to share the latest data from our ongoing phase 2 GBM trial at ESMO, which highlight BPM31510’s unique mechanism of reprogramming tumor metabolism to potentially improve treatment outcomes in glioblastoma, one of the most aggressive tumors” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “We appreciate our world-class partners like Stanford and Aixial Group for their continued collaboration and support as we advance BPM31510 into late-stage development.”

Poster Presentations

1. Interim Analysis of a Phase 2 Study of BPM31510 with Vitamin K in Combination with Standard Chemoradiation in Newly Diagnosed GBM Patients

• Collaborators: BPGbio, Stanford University, Aixial Group
• Design: Phase 2, single-arm, open-label trial (BPM31510IV-11; NCT04752813) testing BPM31510 with Vitamin K alongside radiotherapy and temozolomide (TMZ) in newly diagnosed GBM.
• Endpoints: Primary endpoints are progression-free survival at 6 months (PFS6) and 12 months (PFS12); secondary endpoints include overall survival and safety.
• Update: Interim PFS6 landmark data from 25 patients will be presented, assessing whether mitochondrial reprogramming by BPM31510 enhances standard-of-care efficacy

2. Biomarker Analysis of BPM31510 in Recurrent, Bevacizumab-Refractory High-Grade Glioma Shows Effects on Metabolic and Tumor Progression Markers

• Collaborators: BPGbio, Stanford University
• Insights: Phase 1 pharmacodynamic data (BPM31510IV-06; NCT03020602)
  • Demonstrate the pharmacodynamic effect of BPM31510 on mitochondrial oxidative phosphorylation
  • Reveals alterations in proteins linked to glioma progression
  • Suggests a potential impact on tumor growth
    

About BPM31510

BPM31510IV is BPGbio’s lead candidate in late-stage development for aggressive solid tumors such as glioblastoma multiforme (GBM) and pancreatic cancer. Other topical and oral formulations of the investigational agent are also being developed as a potential treatment for several rare diseases including Primary CoQ10 Deficiency (PCQD). The compound has demonstrated a tolerable safety profile and is being studied for potential clinical benefits across multiple disease indications. Validated by BPGbio’s NAi Interrogative Biology platform, BPM31510 is designed to induce a hallmark shift in the tumor microenvironment (TME) by modulating mitochondrial oxidative phosphorylation in aggressive tumors, promoting programmed cell death (apoptosis). In many mitochondrial diseases, restoring CoQ₁₀ levels can overcome the effect of mutations in genes that lead to mitochondrial dysfunction. BPM31510 has been granted Orphan Drug Designation by the FDA for GBM, pancreatic cancer, and epidermolysis bullosa (EB), as well as Rare Pediatric Disease Designation for primary CoQ10 deficiency and EB.

Media contact: Media@bpgbio.com

About BPGbio:

BPGbio is a leading biology-first AI-powered clinical stage biopharma focused on mitochondrial biology and protein homeostasis. The company has a deep pipeline of AI-developed therapeutics spanning oncology, rare disease and neurology, including several in late-stage clinical trials. BPGbio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 500 US and international patents; one of the world’s largest clinically annotated non-governmental biobanks with longitudinal samples; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using bespoke Bayesian AI specifically designed for solving large-scale biology challenges. Headquartered in greater Boston, the company is at the forefront of a new era in medicine, combining biology, multi-modal data, and AI to transform the way we understand, diagnose, and treat disease. For more information, visit www.bpgbio.com.

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