BPGbio Presents Phase 2 Glioblastoma Data Update at ESMO Congress 2026, Highlighting Median Overall Survival of 19.9 Months in MGMT-Unmethylated Patients
Median overall survival of 19.9 months in patients with MGMT-unmethylated glioblastoma compares favorably with
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- Median overall survival of 19.9 months in patients with MGMT-unmethylated glioblastoma compares favorably with historical outcomes
- BPM31510 demonstrated a well-tolerated safety profile in combination with standard-of-care radiation therapy and temozolomide
- Findings support further clinical development of BPM31510, with planning for a future registrational trial underway
MADRID and BOSTON, Oct. 26, 2026 (GLOBE NEWSWIRE) — BPGbio, Inc., a clinical-stage biopharmaceutical company advancing mitochondrial-targeted therapeutics for patients, today announced encouraging updated results from its Phase 2 clinical trial evaluating BPM31510, an investigational mitochondrial modulator, in combination with standard-of-care radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed glioblastoma multiforme (GBM) patients. The findings were presented on October 24th at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
The multi-center Phase 2 study (NCT04752813) is evaluating BPM31510, a lipid nano dispersion of oxidized CoQ10 administered with vitamin K1, as a neo-adjuvant and concurrent therapy alongside RT and TMZ in newly diagnosed GBM patients who have not received prior treatment.
Key Findings from the Phase 2 Study
- Overall Survival: Median OS reached 19.6 months in the per-protocol population (N=44).
- MGMT- Unmethylated Patients: Median OS reached 19.9 months (N=28), comparing favorably with historical median OS of 12.7–15.5 months.
- Tumor Response: At 12 months, the overall response rate was 11.4% and disease control rate was 50.0%, increasing to 17.9% and 60.7%, respectively, in MGMT-unmethylated patients.
- Safety and Tolerability: BPM31510 was generally well tolerated, with investigators concluding that it did not appear to exacerbate the toxicity profile of standard-of-care RT and TMZ.
“These updated findings are particularly encouraging in patients with MGMT-unmethylated glioblastoma, who historically have had limited therapeutic options and poorer outcomes,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “The median overall survival approaching 20 months in this challenging patient population reinforces our belief in the potential of mitochondrial metabolic modulation as a new therapeutic approach in oncology. Together with the observed safety and tolerability profile, these results provide a strong rationale for advancing BPM31510 toward a registrational trial.”
“Glioblastoma is a highly aggressive disease, and there remains a significant need for treatments that work through mechanisms beyond conventional therapies,” said Seema Nagpal, MD, Clinical Professor of Neurology, Stanford University School of Medicine. “What makes BPM31510 interesting is its approach to targeting altered tumor metabolism. The findings from this study provide an important foundation for further clinical investigation to better understand the role of mitochondrial metabolic modulation in treating glioblastoma.”
BPM31510 is designed to target the tumor microenvironment and alter the mitochondrial metabolic machinery to modulate oxidative phosphorylation reactivation and ROS production, thereby restoring the apoptotic function in tumors. In cancer, altered mitochondrial metabolism supports tumor growth, therapeutic resistance and adaptation to oxidative stress. BPM31510 was designed to address these metabolic vulnerabilities while supporting efficient metabolism in non-tumorigenic tissues.
The Phase 2 study (NCT04752813) has completed enrollment, with 51 patients enrolled across leading U.S. cancer centers. BPGbio anticipates topline data from the final analysis of the study in early 2027 and is currently planning the registrational trial.
The ESMO presentation, titled “Results from Phase 2 Study of BPM31510 in Combination With Standard of Care (SOC) RT and TMZ in Newly Diagnosed Glioblastoma (GB)” (Abstract 727TiP), was presented by study investigator Brian Stocksdale, M.D., Assistant Professor of Neuro-Oncology, Department of Neurosurgery and Massey Comprehensive Cancer Center, Virginia Commonwealth University. The poster can be found here.
Media Contact:
Media@bpgbio.com
About BPGbio
BPGbio is a clinical-stage biopharmaceutical company advancing mitochondrial-targeted therapeutics for patients. The company’s lead investigational therapeutic, BPM31510, is designed to modulate mitochondrial function and address diseases associated with mitochondrial dysfunction and altered cellular metabolism. BPGbio is advancing a pipeline of mitochondrial therapies aimed at improving outcomes for patients with significant unmet medical needs.
Learn more at www.bpgbio.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2b0aa47a-e8d2-4edf-9f9a-f46e5d115aef
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