On January 18, 2024 BPGbio, Inc. a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, reported new data from a phase 2a clinical trial of its lead candidate, BPM31510, in patients with advanced pancreatic cancers at the annual ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, being held January 18-20, 2024, in San Francisco, Calif (Press release, BPGbio, JAN 18, 2024, View Source [SID1234639344]). The multicenter, open-label, non-randomized study aimed to understand the safety and efficacy of BPM31510 delivered intravenously in conjunction with gemcitabine as a second- or third-line therapy for advanced pancreatic cancer.

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In the phase 2a trial (NCT02650804), 19 patients with refractory pancreatic cancer previously treated with other therapies were enrolled and treated with BPM31510 in combination with gemcitabine. Among study participants, median progression free survival was 7.2 months (range: 3.8 months – 10.5 months), twice the observed median progression free survival (3.6 months) reported in patients receiving treatment with gemcitabine alone.

"BPM31510 offers the potential to alter the microenvironment of pancreatic cancer tumors with very manageable side effects, making it an ideal partner to combine with other systemic therapies," said Madappa Kundranda, M.D., Ph.D., Chief of Division of Cancer Medicine, Banner MD Anderson Cancer Center, who was the principal investigator of the study. "Pancreatic cancer, because it is so often diagnosed at later stages, has proven difficult to treat with traditional approaches, which is what makes the sensitizing effects of BPM31510 so compelling."

"These data have validated the BPM31510 mechanism of action and once again show the success of our biology-first Bayesian AI approach to drug development in the clinic," said Niven Narain, Ph.D., CEO of BPGbio. "We see broad applicability for BPM31510 across many solid tumor cancers given its properties as a chemotherapy and radiation sensitizer, and remain committed to pursuing additional clinical studies in both pancreatic cancer and glioblastoma multiforme to address these critical areas of unmet patient need."

ASCO-GI Presentation Summary
Abstract #: 696
Abstract Title: Predictive Multi-omics Analysis of BPM31510 in Combination with Gemcitabine in a Phase 2 Study of Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
In-Person Session Name: Poster Session B
In-Person Poster Session Date: January 19, 2024 at 12:30-2 p.m.
Presenter: Madappa Kundranda, M.D., Ph.D.

BPM31510 as a treatment for pancreatic cancer has received Orphan Drug Designation from the U.S. Food and Drug Administration. BPM31510 is a proprietary nano-lipid molecule designed to target the tumor microenvironment and induce cancer cell death with minimal toxicity. It does this by modulating mitochondrial oxidative phosphorylation in highly aggressive solid tumors, with a direct effect on the BCL-2 protein family. It is believed to be a sensitizer to other chemotherapies, including gemcitabine, as was tested in this study, as well as radiation.

BPGbio plans to continue to study BPM31510 in pancreatic cancer with a phase 2b study looking at its effect as a first line therapy in combination with gemcitabine. In addition, the company has an ongoing phase 2b trial (NCT04752813) studying BPM31510 in combination with vitamin K and standard chemoradiation therapy in patients with glioblastoma multiforme (GBM).

Narain continued, "As a company, we see BPM31510 as offering promise in many other solid tumor cancers including gastric, esophageal, liver, bladder, and sarcoma, where innovation is critically needed."

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.