• Clinical researchers from Stanford Medicine to present update on ongoing GBM trial
• Quinomics assessment visualizes in detail how BPM31510 treatment works inside the brain and patient

BPGbio Presents Phase 2b BPM31510 Glioblastoma Trial-in-Progress Update and Pioneering Comprehensive Quinomics Assessment at the ESMO Congress 2024

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BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced that researchers will present two posters on the ongoing phase 2 trial (NCT04752813) of BPGbio lead candidate, BPM31510, in patients with newly diagnosed glioblastoma multiforme (GBM) at the European Society for Medical Oncology (ESMO) Congress 2024, taking place September 13-17 in Barcelona.

Seema Nagpal, MD, Clinical Professor of Neurology at Stanford Medicine and principal investigator of the trial, will be presenting the latest data from the ongoing trial which has enrolled sixteen (16) patients and seven (7) completed the study. Dr. Nagpal and her colleagues at Stanford will also present the cutting-edge quinomics assessment of BPM31510 which shows visualized in vivo effect of the drug on an experimental glioma model and in the brain and provides data validating metabolic activity.

“We are excited to present the latest data from the BPM31510 GBM phase 2 trial at the ESMO Congress,” said Dr. Seema Nagpal, Clinical Professor of Neurology at Stanford Medicine and principal investigator of the trial. “GBM remains one of the most aggressive and lethal forms of brain cancer and the new data obtained from our clinical research have provided significant insights into its treatment.”

“Being able to visually see exactly how a drug is working metabolically on an aggressive experimental brain tumor and in the brain uncovered new findings related to brain cancer therapeutic development,” said Lawrence Recht, MD, Professor of Neurology and of Neurosurgery at Stanford Medicine. “We look forward to sharing this exciting data with industry peers and fellow researchers.”

BPM31510, combined with Vitamin K and standard chemoradiation, is being tested in a single-arm Phase 2b trial across four U.S. sites, with a total target enrollment of 50 patients.

“The preliminary results from the ongoing clinical trial support our biology-first, AI-driven approach, optimizing patient selection and streamlining drug development,” said Niven R. Narain, Ph.D., President and CEO of BPGbio, Inc. “We are eager to continue work with the Stanford team and to collaborate with researchers at other top medical centers to complete enrollment in the trial.”

Poster Presentation Details:

Title: Trial in Progress (TiP): 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

Date and Time: Monday, September 16, 2024, 9:00-17:00 CEST

Presentation Number: 499TiP

Speaker: Dr. Seema Nagpal

Title: Comprehensive Quinomics Assessment of BPM31510IV Treatment in Advanced Glioblastoma Multiforme Patients

Date and Time: Monday, September 16, 2024, 9:00-17:00 CEST

Presentation Number: 472P

Speaker: Dr. Seema Nagpal

These posters will be available on BPGbio.com following the ESMO meeting.

About BPM31510

BPM31510 is BPGbio’s lead candidate in late-stage development for glioblastoma multiforme (GBM) and pancreatic cancer. The compound has demonstrated a tolerable safety profile and shown potential clinical benefit in both populations. The mechanism of action of BPM31510 was first validated by data from BPGbio’s NAi Interrogative Biology platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) induced by BPM31510 which modulates mitochondrial oxidative phosphorylation in highly aggressive tumors. BPM31510 has been granted Orphan Drug Designation by the FDA for both GBM and pancreatic cancer indications.

About Quinomics

Quinomics is the comprehensive measurement of quinone metabolites predominantly characterized by the classical phenolic ring structure and can represent synthesis or metabolites of CoQ10. Quinones have critical roles in antioxidant status, mitochondrial function, redox balance, and coagulation status.

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 400 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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