ubidecarenone IV (BPM31510 IV) / BPGbio - LARVOL DELTA

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

Preliminary Results from Phase 2 Study of BPM31510 in Combination with Standard of Care (SOC) RT and TMZ in Newly Diagnosed Glioblastoma (GBM) (ESMO 2026) - No abstract available

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

BPGbio Reports Encouraging Preliminary Data from Ongoing Phase 2 Study of BPM31510 in Newly Diagnosed Glioblastoma (GlobeNewswire) - "Unmethylated subgroup: In 24 patients with MGMT unmethylated tumors, a group associated with poor prognosis and efficacy to standard of care—BPGbio observed a preliminary median OS of 29.3 months, nearly doubling the historical control baseline of 12.7-15.5 months. Methylated subgroup: The median OS for the MGMT methylated patient cohort has not yet been reached due to high ongoing survival rates....The Phase 2 study has completed enrollment, with 51 patients enrolled across leading U.S. cancer centers. BPGbio anticipates topline data from the study in late fall 2026....BPGbio anticipates presenting more advanced data from the Phase 2 trial at the European Society of Medical Oncology (ESMO) Meeting in Madrid, Spain this Fall."

Enrollment closed • P2 data • Glioblastoma

BPM31510IV-11: A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: BPGbio | Trial primary completion date: Feb 2025 ➔ Sep 2025

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Progress report of a phase 2 study of BPM31510 (a lipid nano dispersion of oxidized CoQ10) with vitamin K in combination with standard of care (SOC) RT and TMZ in glioblastoma multiforme (GBM) patients without prior therapy. (ASCO 2026) - P2 | "All coagulation related issues were alleviated by coadministration of Vitamin K. The Phase 2 trial in newly diagnosed patients with glioblastoma tests whether treatment with BPM31510 results in improved efficacy of standard of care temozolomide (TMZ) and radiotherapy (RT). After two weeks, standard of care chemoradiation and TMZ are started in combination with weekly IV BPM31510 for 8 weeks, after which IV BPM31510 treatment and standard RT are discontinued with subjects continuing to receive maintenance TMZ treatment for up to 12 cycles as per standard of care. Of the approximately 50 patients enrolled and treated upon the recommendation of an independent safety monitoring committee, 25 will be available for PFS6 efficacy endpoint analysis and these data will be presented."

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

BPGbio…announced that new clinical progress from its ongoing Phase 2 study of BPM31510 in newly diagnosed glioblastoma multiforme (GBM) will be presented at the upcoming ASCO Annual Meeting (GlobeNewswire) - "The ongoing Phase 2 study is evaluating BPM31510, an investigational lipid nanodispersion formulation of oxidized Coenzyme Q10 (CoQ10), administered with vitamin K1 in combination with standard-of-care radiation therapy (RT) and temozolomide (TMZ) in patients with newly diagnosed GBM who have not received prior therapy....Both safety profile and efficacy data to be highlighted in methylated and unmethylated GBM tumors."

P2 data • Trial status • Glioblastoma

BPM 31510: Targeting the tumor microenvironment (TME) via mitochondrial-mediated ROS production (AACR 2024) - "Currently, an ongoing first-line phase 2b study of BPM 31510 in glioblastoma in combination with radiotherapy and temozolomide will assess the clinical efficacy and potential for mechanistic synergy of multiple ROS-inducing mitochondrial mediated regimens on this aggressive cancer phenotype. BPM 31510 will be assessed in this study to provide further evidence for the impact of ROS on immunomodulation. Taken together, BPM 31510 increases mitochondrial ROS/OXPHOS in cancer cells while impacting TME-related immune cell modulation."

Biomarker • Tumor microenvironment • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • CD4 • CD8

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 Receives FDA Orphan Drug Designation for BPM31510 for the Treatment of Primary CoQ10 Deficiency (GlobeNewswire) - "The designation was supported by data-driven insights generated through BPGbio’s proprietary NAi Interrogative Biology platform, which uniquely utilizes Bayesian AI to map thousands of human biological data points."

Orphan drug • Genetic Disorders • Rare Diseases

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

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