• Researchers from clinical trial site present trial data at the SNO Meeting
• BPGbio’s biology-first AI approach to drug discovery employed in BPM31510

BPGbio, Inc., a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, today announced that researchers will present data from an ongoing phase 2 trial study of BPGbio lead candidate, BPM31510, in patients with newly diagnosed glioblastoma multiforme (GBM), at the Society for Neuro-Oncology Annual Meeting being held November 16-19, 2023 in Vancouver, Canada.

"We are delighted to share the developments of the BPM31510 GBM trial with the neuro-oncology community," stated Seema Nagpal, MD, Clinical Professor of Neurology at Stanford Medicine and the trial's principal investigator. "The information gathered from preclinical and clinical research has offered valuable insights into treatment for GBM, and we eagerly anticipate continuing to advance our discoveries with neoadjuvant BPM31510."

GBM is one of the most aggressive forms of brain cancer with survival times averaging only 15-18 months from diagnosis, and a five year survival rate under 10 percent. There are approximately 13,000 new cases of GBM-related tumors annually in the U.S., occurring more frequently in patients over age 60. BPM31510 as a treatment for GBM has received Orphan Drug Designation from the U.S. Food and Drug Administration.

The ongoing first-line Phase 2b trial (NCT04752813) follows a successful 104-patient Phase 1a/b clinical trial, which demonstrated both the safety and efficacy of BPM31510. The results from that trial enabled BPGbio to build a dynamic patient-based AI model to better understand the compound’s mechanism of action and predict who may be most likely to respond to the therapy. The Phase 1a/b data, which were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2019, helped the BPGbio team plan for a Phase 1b trial in advanced GBM patients, where BPM31510 was well tolerated.

“The initial data from our ongoing clinical development of BPM31510 suggests early promise and brings new hope to patients with some of the most aggressive and difficult-to-treat cancers of the brain and pancreas. It also validates our biology-first AI approach to making clinical development more efficient,” said Niven R. Narain, Ph.D., President and CEO, BPGbio, Inc. “Our NAi Interrogative Biology platform guided our development team throughout the process, helping us optimize our clinical trials with the appropriate patient cohorts. We look forward to advancing the trial with the Stanford team and other leading medical centers.”

The ongoing trial, which plans to enroll 50 patients, is a single arm dose-confirmation trial where patients are dosed with BPM31510 in combination with Vitamin K and standard chemoradiation therapy. BPGbio is planning to expand the Phase 2b trial to new clinical sites in the United States and the United Kingdom.

Presentation Summary

Abstract #: CTNI-27

Abstract Title: Trial In Progress: A phase 2 study of BPM31510 (an oxidized CoQ10-lipid conjugate nanodispersion) with vitamin K and standard chemoradiation in newly diagnosed glioblastoma

In-Person Session Name: Poster Session

In-Person Poster Session Date: Friday, November 17, 2023

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.

About BPGbio, Inc.

BPGbio is a leading AI-powered clinical stage biopharma and diagnostics company focused on oncology, neurology, and rare diseases. The company has a deep portfolio of AI-developed pipeline of therapeutics, including several in late-stage development. BPGBio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 400 US and international patents; the world’s largest clinically annotated non-governmental biobank; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using unbiased AI. Headquartered in Boston, the company is at the forefront of a new era in medicine, combining biology, data, and AI to transform the way we understand aging, human performance, and diagnose and treat disease. For more information, visit bpgbio.com.

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