• Mitochondrial mechanism of action leading to cancer cell death discovered by proprietary artificial intelligence platform
• Assessing additional US and UK clinical sites for potential participation

BPGbio, Inc., a leading AI-powered biopharma that focuses on oncology, neurology and rare diseases, today announced that patients have been initially dosed in its Phase 2 trial for BPM 31510 for Glioblastoma Multiforme (GBM), a fast-growing and aggressive form of brain cancer.

BPM 31510, the company’s lead drug candidate, acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death. BPM 31510 for GBM is one of the three oncology drug assets in clinical phase that BPGbio developed on its AI-driven Interrogative Biology® platform.

GBM is one of the most aggressive forms of brain cancer with survival times averaging only 15-18 months from diagnosis, the 5 year survival rate is under 10 percent. There are approximately 13,000 new cases of GBM-related tumors annually in the US, occuring more frequently in patients over 60.

In preclinical studies in orthotopic models of GBM, pre-treatment with BPM 31510 followed by radiation therapy was associated with significant long-term survival compared to radiation alone, while BPM 31510 showed an anti-cancer effect in GBM patients without damaging normal brain cells. A Phase 1 trial in advanced, refractory GBM patients completed at Stanford Medicine demonstrated a favorable safety profile of BPM 31510, supporting Phase 2 trial advancement.

“This milestone is a testament to the value of our Interrogative Biology® platform and its capability to develop drugs for the treatment of deadly diseases where patients desperately need better therapeutics,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “Advancing this candidate into Phase 2 human trials is a big step of progress for both the company and patients suffering from GBM.”

The open-label, multi-cohort Phase 2 study for BPM 31510 for treatment of GBM is led by Seema Nagpal, MD, Clinical Associate Professor, Division of Neuro-Oncology at Stanford Medicine. The study will include planned interim analyses primary, secondary and exploratory endpoints. Current clinical sites include lead site Stanford Medicine, Cedars-Sinai Medical Center in Los Angeles and Mt. Sinai Medical Center in New York. Additional sites are currently being assessed in the United States and the United Kingdom.

“The combined preclinical and phase 1 safety and tolerability data provided valuable insights into treatments for Glioblastoma Multiforme. Leveraging the results from the phase 1 clinical trial, we are looking forward to further advance our discoveries using neoadjuvant BPM 31510 in phase 2,” said Seema Nagpal, MD.

About BPGbio, Inc.

BPGbio, Inc., is a leading AI-powered, human-biology-centered biopharmaceutical company headquartered in the greater Boston, Massachusetts. With its intelligent Interrogative Biology^® platform and the largest clinically annotated non-governmental human sample biorepository in the world, BPGbio is reimagining how patient biology can be modeled using unbiased AI to accelerate and de-risk the process of drug discovery across oncology, neurology, and rare diseases. For BPGbio therapeutics and diagnostics pipeline, visit www.bpgbio.com

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