On September 30, 2019 BERG, a biopharmaceutical company active in the clinical stage, that uses artificial intelligence (AI) and multi-omics to identify novel biological bases and disease-modifying targets, reported that it has a predictive outcome Analysis of adverse events published using the BERG platform (Press release, Berg, SEP 30, 2019, View Source [SID1234539956]). The underlying multicentre Phase 1 trial will examine BPM31510 (novel ubidecarenone formulation) in 104 patients with advanced relapsed / refractory solid tumors. The results of the study were presented during a poster session during the annual meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Barcelona .
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"These data corroborate the growing evidence base in favor of the tremendous contribution that our Interrogative Biology platform can make to drug development," said Dr. Niven R. Narain , co-founder, president and chief executive officer of BERG . "With insights into the exact The molecular and pharmacodynamic profile of an early-stage drug enables researchers to create a better risk assessment profile for an investigational medicinal product, which can have a positive impact on the timing, development costs and success of a drug candidate.
This is the first clinical study to extract tissue specimens and biofluids from individual patients with solid tumors on a longitudinal basis for panomic analysis at various times. The aim of the study was to validate that BERG, based on systems biology and a Bayesian AI platform, is able to provide biological insights into the mechanism of action of BPM31510, to interpret the biological markers and / or features for the prediction of adverse events correlate clinical success data. BERG is intended to create a model that makes the clinical examination process significantly more efficient. "
Dr. Vivek Subbiah , principal investigator of the Phase 1 study at the MD Anderson Cancer Center, said: "Therapy-related events can potentially bring down the development of critical agents when patients drop out of or opt-out of study treatment. With insights into the biological foundations of potential adverse events (AEs), we can generate better clinical trials by addressing these events – for example, by excluding patient subgroups or integrating prophylactic interventions for these expected events into the study design. "
"The data presented suggest a good tolerability of BPM31510, with safety being confirmed at all dose levels as monotherapy or combination therapy. The anti-tumor response shown in the poster suggests the potential potency of the drug, "said Dr. Linda Vahdat , Professor of Medicine at Weill Cornell Medicine." The BERG Interrogative Biology platform has provided insights into the molecular mechanisms involved BPM31510 on the other hand, and an action-relevant management plan for adverse events allows. "
Details of Presentation:
Date: Saturday, September
28 , 2019 Proteomic Profiling Identifies Molecular Basis of Adverse Event to BPM31510 Exposure: Rational for Comprehensive Molecular Pharmacodynamics (PD) in Phase 1 Clinical Trial Design (ID 4615) Presentational ID : 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 is collaborating with leading institutions such as the Stanford Medical Center (Glioblastoma Research and Phase 1 Trial) and Harvard / Beth Israel Deaconess Medical Center (Project Survival / Pancreatic Cancer, Phase 2 Trial) on research to complete the To improve the lives of cancer patients.