BPGbio, an AI-powered biopharma that focuses on oncology, neurology, and rare diseases, has announced new data from a Phase IIa clinical trial of its lead candidate, BPM31510, in patients with advanced pancreatic cancers at the annual ASCO Gastrointestinal Cancers Symposium, being held 18-20 January 2024, in San Francisco.
The multicentre, open-label, non-randomised 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.
In the Phase IIa 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 tumours with very manageable side effects, making it an ideal partner to combine with other systemic therapies,” said Madappa Kundranda, 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 sensitising 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, CEO of BPGbio. “We see broad applicability for BPM31510 across many solid tumour cancers given its properties as a chemotherapy and radiation sensitiser, and remain committed to pursuing additional clinical studies in both pancreatic cancer and glioblastoma multiforme to address these critical areas of unmet patient need.”
Looking forward: BPM31510
BPM31510 as a treatment for pancreatic cancer has received Orphan Drug Designation from the US Food and Drug Administration. BPM31510 is a proprietary nano-lipid molecule designed to target the tumour microenvironment and induce cancer cell death with minimal toxicity. It does this by modulating mitochondrial oxidative phosphorylation in highly aggressive solid tumours, with a direct effect on the BCL-2 protein family. It is believed to be a sensitiser 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 IIb study looking at its effect as a first line therapy in combination with gemcitabine. In addition, the company has an ongoing Phase IIb 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 tumour cancers including gastric, esophageal, liver, bladder, and sarcoma, where innovation is critically needed.”