Results from the study were presented at the ASCO Gastrointestinal Cancers Symposium on 18 January. Credit: Jo Panuwat D via Shutterstock.

BPGBio has announced early data indicating where its small molecule drug BPM 31510 (ubidecarenone) doubled progression free survival (PFS) when combined with gemcitabine in participants with advanced pancreatic cancer. 

BPM 31510, a naturally occurring coenzyme structurally similar to vitamin K, works with mitochondria to restore cellular energy processes and induce cell death in cancer cells by mimicking the potential of the BCL-2 protein family. In the 19-patient cohort of the Phase IIa study (NCT02650804), those who received BPM 31510 intravenously alongside chemotherapy as a second and third-line treatment, the BPM 31510 group reported a median PFS of 7.2 months, compared to the observed median PFS of 3.6 months in the gemcitabine cohort.

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The results were presented at the ongoing 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, US on 18 January. As per the company, BPM 31510 also demonstrated a tolerable safety profile in preclinical studies. Its antioxidant properties contribute to cancer prevention by protecting cells against free radicals. 

The US Food and Drug Administration (FDA) granted orphan drug designation to the candidate back in 2018, when it was being developed by the biopharmaceutical company BERG. In February last year, BPGBio purchased BERG, acquiring the company’s investment artificial intelligence (AI) platform, which was built with an investment of $400m.  

BPGBio plans to initiate a Phase IIb study of BPM 31510 in pancreatic cancer as a first-line therapy in combination with gemcitabine. 

The company also has an ongoing Phase IIb trial (NCT04752813) investigating BPM 31510 in combination with vitamin K and chemoradiation therapy in glioblastoma multiforme (GBM) patients. Preclinical studies showed long-term survival and anti-cancer effects without damaging normal brain cells.  

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The study utilised BPGBio’s Bayesian AI platform, which optimises the integration of experimental data and prior knowledge in drug discovery. The Bayesian approach refines predictions about drug efficacy and mechanism of action, enhancing decision making by accounting for uncertainties and facilitating a nuanced understanding of potential outcomes in the drug development process. 

According to a report on GlobalData’s Pharma Intelligence Center, the AI sector is forecast to grow from $81.3bn in 2022 at a compound annual growth rate (CAGR) of 35.2% to $908.7bn in 2030, globally. AI has been identified as a key driver of future healthcare innovation. 

GlobalData is the parent company of Clinical Trials Arena. 

In the announcement accompanying the data, principal investigator of the study Madappa Kundranda said: “BPM 31510 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.”