Early phase study of BPM31510 demonstrates BERG's Interrogative Biology® platform can identify the molecular basis of efficacy and adverse events, offering critical insights for drug late-stage development from analyses of longitudinal patient samples
FRAMINGHAM, Massachusetts, Sept. 28, 2019 /PRNewswire/ -- BERG, a clinical stage biopharmaceutical company that utilizes artificial intelligence (AI) and multi-omics to identify novel biology and disease modifying targets, today announced results from a predictive analysis of adverse events by the BERG platform, for a multi-center Phase 1 study evaluating BPM31510 (novel ubidecarenone formulation) in 104 patients with advanced relapsed/refractory solid tumors. The findings from the study were presented during a poster session at the European Society for Medical Oncology (ESMO) annual meeting in Barcelona.
"These data add to the growing body of evidence supporting the profound role that our proprietary Interrogative Biology® platform can play in drug development," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "Understanding a drug's comprehensive molecular and pharmacodynamic profile in the early stages of development will allow researchers to create a better risk-management profile of an investigational compound, which might positively impact timelines, development costs, and the potential success of a drug candidate.
The clinical study presented is the first to collect tissue samples and biofluids on a longitudinal basis for a pan-omic analyses at multiple time points on each patient in a solid tumor setting. The goal of the study was to validate that, with the use of systems biology and Bayesian AI platform, BERG would be able to derive biological insights into the mechanism of action of BPM31510 and assess the biological markers or features that may be a predictor to any adverse events and correlate them to the clinical outcome data. BERG's approach and mission to advance this as a model that will drive much more efficiency in the clinical trial process.
According to Dr. Vivek Subbiah, the primary investigator of the Phase 1 study at the MD Anderson Cancer Center, "Treatment-emergent events have the potential to derail the development of critical medicines as they can result in patients discontinuing study treatment or dropping out of trials. Insights into the biological basis for potential adverse events (AEs) may allow us to design better clinical trials by addressing the occurrence of these events, either by excluding patient subgroups or incorporating prophylactic interventions for these anticipated events into study design."
"The data presented indicated that BPM31510 is well tolerated, with safety established at all doses tested as a monotherapy or combination therapy. The antitumor responses presented in the poster point to the potential efficacy of the drug," said Dr. Linda Vahdat, Professor of Medicine at Weill Cornell Medicine. "The BERG Interrogative Biology® platform has not only provided insights into the molecular pathways elicited by BPM31510 exposure but also an actionable management plan for adverse events."
Details of the presentations include: Date: Saturday, September 28, 2019 Proteomic Profiling Identifies Molecular Basis of Adverse Event to BPM31510 Exposure: Rationale for Comprehensive Molecular Pharmacodynamics (PD) in Phase 1 Clinical Trial Design (ID 4615) Presentation Number - 498P Location - Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain Time - 12:00 - 13:00
In addition to the MD Anderson Cancer Institute, BERG collaborates with leading institutions like Stanford Medical Center (glioblastoma research and Phase 1 trial) and Harvard/Beth Israel Deaconess Medical Center (Project Survival/Pancreatic Cancer Phase 2 trial), among others, in its commitment to serve patients afflicted with cancer.
About BERG BERG LLC is a clinical-stage, artificial intelligence-powered biotech leveraging its proprietary platform, Interrogative Biology(®), to map disease and revolutionize treatments across oncology, neurology and rare diseases. By taking a Back to Biology((TM)) approach, BERG is able to identify critical biomarkers that can accelerate the discovery and development of treatments aimed at the most promising therapeutic targets and pathways. BERG has leveraged both Interrogative Biology(®) and traditional R&D methods to develop a robust pipeline of first-in-class product candidates and diagnostics that advance bold innovations that have the potential to improve patient lives.
We are grateful to our patient and family partners for their participation in these critical efforts to improve cancer care.
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