ubidecarenone IV (BPM31510 IV) / BPGbio - LARVOL DELTA

BPM31510 engagement of the Warburg effect in GBM to therapeutically modulate tumor metabolism through ROS mediated processes preclinically and clinically (SNO 2025) - P1, P2 | "This analysis has revealed a clear impact of the ubiquinone biosynthesis pathway in cancer that can be therapeutically leveraged through the actions of BPM31510 to induce ROS leading to potentially improved clinical outcome in GBM patients."

Preclinical • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Trial in Progress (TiP): Interim analysis of a Phase 2 study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with Vitamin K in combination with Standard of Care (SOC) RT and TMZ in Glioblastoma Multiforme (GBM) patients without prior therapy (SNO 2025) - P2 | "A 90% power in rejecting the null hypothesis of PFS6 of ≤ 30% at the interim analysis will drive futility. This data will be available and presented."

Clinical • Combination therapy • P2 data • Brain Cancer • Glioblastoma • Solid Tumor

A novel therapeutic strategy using a single non-toxic agent that produces consistent long-term control of orthotopic experimental glioblastomas. (SNO 2025) - "These findings demonstrate that BPM31510 has the capacity to be an effective, non-toxic agent with great clinical potential. We hypothesize that unlike most conventional anticancer agents that much of its effect results from its capacity to restore tissue homeostasis and enhance healing."

Brain Cancer • Glioblastoma • Glioma • Solid Tumor

A novel therapeutic strategy using a single non-toxic agent that produces consistent long-term control of orthotopic experimental glioblastomas. (SNO 2025) - "These findings demonstrate that BPM31510 has the capacity to be an effective, non-toxic agent with great clinical potential. We hypothesize that unlike most conventional anticancer agents that much of its effect results from its capacity to restore tissue homeostasis and enhance healing."

Brain Cancer • Glioblastoma • Glioma • Solid Tumor

BPM31510 engagement of the Warburg effect in GBM to therapeutically modulate tumor metabolism through ROS mediated processes preclinically and clinically (WFNOS 2025) - P1, P2 | "This analysis has revealed a clear impact of the ubiquinone biosynthesis pathway in cancer that can be therapeutically leveraged through the actions of BPM31510 to induce ROS leading to potentially improved clinical outcome in GBM patients."

Preclinical • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Trial in Progress (TiP): Interim analysis of a Phase 2 study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with Vitamin K in combination with Standard of Care (SOC) RT and TMZ in Glioblastoma Multiforme (GBM) patients without prior therapy (WFNOS 2025) - P2 | "A 90% power in rejecting the null hypothesis of PFS6 of ≤ 30% at the interim analysis will drive futility. This data will be available and presented."

Clinical • Combination therapy • P2 data • Brain Cancer • Glioblastoma • Glioma • Solid Tumor

A novel therapeutic strategy using a single non-toxic agent that produces consistent long-term control of orthotopic experimental glioblastomas. (WFNOS 2025) - "These findings demonstrate that BPM31510 has the capacity to be an effective, non-toxic agent with great clinical potential. We hypothesize that unlike most conventional anticancer agents that much of its effect results from its capacity to restore tissue homeostasis and enhance healing."

Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A novel therapeutic strategy using a single non-toxic agent that produces consistent long-term control of orthotopic experimental glioblastomas. (WFNOS 2025) - "These findings demonstrate that BPM31510 has the capacity to be an effective, non-toxic agent with great clinical potential. We hypothesize that unlike most conventional anticancer agents that much of its effect results from its capacity to restore tissue homeostasis and enhance healing."

Brain Cancer • Glioblastoma • Glioma • Solid Tumor

Phase 1a/b Multi-Center Study of BPM31510IV Targeting Mitochondrial Metabolism/Warburg Effect as Monotherapy and Combination Chemotherapy in Solid Tumor Patients. (PubMed, Cancer Res Commun) - "BPM31510IV monotherapy and in combination with chemotherapy was safe, with preliminary evidence of anti-tumor activity. High plasma CoQ10 levels were achieved, inducing PD responses consistent with mitochondrial metabolic changes. These findings support continued clinical development of BPM31510IV."

Journal • Monotherapy • P1 data • Oncology • Solid Tumor

BPM31510, a CoQ10-lipid nanoparticle, remodels the tumor microenvironment through immuno-metabolic reprogramming in syngeneic models (SITC 2025) - "Through enhanced T cell recruitment and reduced inhibitory checkpoint expression, BPM31510 creates conditions favorable for ICI response, positioning it for further investigation as a potential candidate for combination immunotherapy regimens. Ongoing investigations focus on identifying the cellular origins of observed metabolic alterations and further characterizing BPM31510's potential to synergize with established checkpoint therapies to overcome treatment resistance."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • CD4 • CD8 • LAG3 • PD-1 • PD-L1

Biomarker analysis of BPM31510 in recurrent bevacizumab-refractory high-grade glioma shows effects on metabolic- and tumor-progression markers (ESMO 2025) - P1 | "Conclusions Analysis of circulating biomarkers in glioma patients demonstrates the pharmacodynamic effect of BPM31510 on mitochondrial oxidative phosphorylation. Additionally, the biomarker profile reveals alterations in proteins linked to glioma progression, suggesting a potential impact on tumor growth."

Biomarker • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • AKT2 • PI3K • SRC

Interim analysis of a phase II study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with vitamin K in combination with Standard of care (SOC) RT and TMZ in glioblastoma multiforme (GBM) patients without prior therapy (ESMO 2025) - P2 | "A 90% power in rejecting the null hypothesis of PFS6 of ≤ 30% at the interim analysis will drive futility. This data will be available and presented."

Clinical • Combination therapy • P2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

BPGbio…announced that it will present two posters on its lead investigational drug BPM31510 for Glioblastoma (GBM)…at the European Society for Medical Oncology (ESMO) Congress 2025 (GlobeNewswire) - "BPGbio has completed the phase 2b enrollment of GBM trial late August this year....Interim PFS6 landmark data from 25 patients will be presented, assessing whether mitochondrial reprogramming by BPM31510 enhances standard-of-care efficacy....Phase 1 pharmacodynamic data (BPM31510IV-06; NCT03020602) demonstrate the pharmacodynamic effect of BPM31510 on mitochondrial oxidative phosphorylation."

Clinical data • Enrollment status • Glioblastoma

The role of progenitor cells and telocytes in the ameliorative effect of Coenzyme Q10 on isoproterenol-induced cardiotoxicity in rats. (PubMed, Histochem Cell Biol) - "A total of 60 Sprague-Dawley rats were divided into six groups (n = 10): Group I: control, Group II: saline control, Group III: oil control, Group IV: ISO, Group V: CoQ10, Group VI: ISO and CoQ10...The presence of telocytes, which play an important role in cardiac regeneration, was visualised by double CD34-c-Kit and CD34-vimentin immunofluorescence staining. The results indicate that CoQ10, through its antioxidant effect, ameliorates cardiac lesions caused by ISO, induces a limited number of cell cycle activators in cardiomyocytes and interstitial cells and has a positive effect on the increase of progenitor cells in the heart."

Journal • Preclinical • Cardiovascular • Fibrosis • Immunology • CD34 • KIT • PCNA • VIM

BPM31510IV-11: A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: BPGbio | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Aug 2030 | Trial primary completion date: Sep 2025 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

BPGbio Announces Completion of Enrollment for Phase 2b Trial of BPM31510 for Glioblastoma (GBM) (GlobeNewswire) - "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."

Enrollment closed • P2b data • Glioblastoma

Antineovascular Effects of Coenzyme Q10 and Vitamin E Combination in Corneal Neovascularization: A Pilot Study. (PubMed, J Ocul Pharmacol Ther) - "Purpose: To evaluate and compare the effects of subconjunctival injection of coenzyme Q10 (CoQ10) and vitamin E (Vit E) ophthalmic solution (Coqun®) with subconjunctival bevacizumab in a suture-induced corneal neovascularization (CoNV) rabbit model. Although it is not less effective than bevacizumab, its neuroprotective properties suggest potential value in cases where CoNV and glaucoma coexist. Further clinical studies are warranted to confirm these findings and to better define its therapeutic role."

Journal • Glaucoma • Ophthalmology

Protective role of coenzyme Q10 against trihexyphenidyl-induced pulmonary toxicity in Wistar rats. (PubMed, BMC Pharmacol Toxicol) - "CoQ10 demonstrated significant protective effects against THP-induced oxidative stress, metabolic disturbances, and apoptosis, likely due to its antioxidant and anti-inflammatory properties. These findings suggest CoQ10 as a potential therapeutic agent for THP-induced pulmonary toxicity, warranting further research."

Journal • Preclinical • CNS Disorders • Dystonia • Metabolic Disorders • Movement Disorders • Parkinson's Disease • CASP3 • CAT

BPGbio Presents Advances in Spatial Omics Technology and Targeted Protein Degradation Insights at ASMS 2025 (GlobeNewswire) - "Presentations highlight cutting-edge research in mitochondrial and neurodegeneration medicine, neurodegeneration, immuno-oncology, and E2-targeted protein degradation using next-generation mass spectrometry."

Preclinical • Oncology

To explore whether a modified myocardial protection solution containing coenzyme Q10 can improve cardiac function in patients with cyanotic congenital heart disease after cardiac surgery. (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine; Shanghai Children's Medical Center, Shanghai Jiaotong Universit

New P4 trial • Cardiovascular • Heart Failure

A phase 2 study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with vitamin K in combination with standard of care (SOC) RT and TMZ in glioblastoma multiforme (GBM) patients without prior therapy (AACR 2025) - P2 | "A 90% power in rejecting the null hypothesis of PFS6 of ≤ 30%. The study is currently open at 8 US sites and has enrolled 20 patients."

Clinical • Combination therapy • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • PGCP • SRC

Investigating the link between metabolic reprogramming and immune modulation in tumors: exploring the therapeutic potential of BPM31510 (AACR 2025) - "Ultimately, this study aims to provide new insights into optimizing BPM31510 treatment strategies, potentially enhancing the effectiveness of immune-based therapies for these difficult-to-treat cancers. By understanding how BPM31510 influences both the immune landscape and metabolic reprogramming of tumors, we hope to develop more effective therapeutic approaches for 'cold' tumors like GBM and pancreatic cancer."

Brain Cancer • CNS Tumor • Glioblastoma • Hematological Malignancies • Oncology • Pancreatic Cancer • Solid Tumor

Reversal of the Warburg Effect with BPM31510 treatment in a quinone deficient C6 Glioma resulting in efficacy (AACR 2025) - "These data definitely demonstrate that BPM31510 is capable of entering the brain and tumor, reengineering mitochondrial metabolism resulting in a resolution of the glioma which impacts survival. Both dosing and sequencing of doses impact outcome and metabolic response."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Mechanisms of BPM31510-induced cell death in cancer: lipid peroxidation and apoptosis pathways (AACR 2025) - "Cells were treated with BPM31510 and Erastin (a ferroptosis inducer) for 3 hours, and fluorescence intensity was measured to assess lipid peroxidation levels. Our findings demonstrate that BPM31510 differentially induces lipid peroxidation in cancer cells through a mechanism independent of ferroptosis, instead activating apoptosis as the primary pathway of cell death. The ferroptosis-independent cytotoxicity of BPM31510, combined with its selective targeting of cancer cells, highlights its potential as a unique therapeutic agent in glioblastoma."

Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • ANXA5

BPGbio Presents New Research on Tumor Metabolism, Immunotherapy, and Diagnostics at AACR Annual Meeting 2025 (GlobeNewswire) - "The featured research spans BPGbio’s oncology pipeline and precision medicine efforts, including mechanistic and clinical insights into BPM31510, a first-in-class oxidized CoQ10 nanodispersion that has demonstrated encouraging results in multiple clinical trials in oncology and other mitochondrial disease areas, and BRG399, a novel microtubule-binding agent that induces immunogenic cell death (ICD). These presentations reinforce BPGbio’s leadership in reprogramming cancer metabolism and targeting mitochondrial dysfunction to drive therapeutic advancement."

Clinical data • Diagnostic • Glioblastoma • Glioma • Oncology