BOSTON, June 4, 2018 /PRNewswire/ -- BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today presented in a poster session at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 1-5, 2018 in Chicago, the findings from a Phase 1 study of its lead product candidate, BPM 31510.
The study evaluated an intravenous (IV) formulation of BPM 31510 alone, or in combination with standard chemotherapy (gemcitabine, 5-FU or docetaxel), for the treatment of advanced solid tumors in patients whose cancer had relapsed or was refractory to standard chemotherapy. The data demonstrate the safety and tolerability of BPM 31510-IV as a monotherapy and in combination with chemotherapy. In addition to the traditional Phase 1 endpoints, the poster featured the development of predictive capability for potential patient response and adverse events through biomarker profiling that will guide Phase 2/3 clinical development.
"These study findings reinforce the power of our Interrogative Biology® and the potential of BPM 31510 to improve cancer treatment for patients as a stand-alone agent or in combination with chemotherapy," said Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "Our biological approach to mapping disease has identified potential predictive biomarkers that will enable us to identify the patients most likely to achieve a treatment response and benefit."
"Relapsed and refractory patients often lack effective treatment options and these results demonstrate BPM 31510 was well-tolerated across tumor types whether used as a monotherapy, or in conjunction with standard chemotherapy," said Vivek Subbiah, M.D., Principal Study Investigator and Assistant Professor, Department of Investigational Cancer Therapies as well as Associate Medical Director of the Clinical Center for Targeted Therapy, University of Texas MD Anderson Cancer Center. "Our analysis also identified potentially predictive biomarkers correlating with favorable clinical response and treatment safety, independent of tumor type and prior therapy."
The poster, titled, "A Phase I Molecular Adaptive Clinical Study to Evaluate Safety and Tolerability of BPM31510-IV in Advanced Solid Tumors: Final Study Results," was presented on Monday, June 4, 2018, 8:00 a.m. – 11:30 a.m. CT during the Developmental Therapeutics — Clinical Pharmacology and Experimental Therapeutics session in Hall A (Abstract #2541).
For more information, please visit the ASCO meeting website at www.abstract.asco.org. Additional information on this clinical trial can be found on www.clinicaltrials.gov using the identifier NCT01957735.
About BPM 31510
Cancer cells alter metabolism to generate energy from non-mitochondrial pathways to support uncontrolled growth. This allows the cancer cells to escape molecular mechanisms controlling cell death. BPM 31510 is a first in class molecule that specifically targets the dysregulated metabolism observed in cancer. BPM 31510, by targeting metabolism in cancer cells, re-engages the mitochondria to generate energy, shifting metabolism to that observed in the normal cell. The effect of BPM 31510 on metabolism results in the reactivation of pathways that detect cell damage, triggering apoptosis or programmed cell death.
BERG, LLC, is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. The platform identifies therapies and biomarkers by applying the algorithm and probability-based artificial intelligence to analyze large numbers of patients' genotypic, phenotypic and other characteristics. BERG's platform operates at the intersection of biology, technology and artificial intelligence analytics, integrating many data characteristics regarding patients' lifestyles, demographics, and biology. The platform aids in understanding patients' disease profiles and consequently, identifying and revealing molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG has the potential to determine novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology. BERG's Interrogative Biology® platform uses bAIcis® artificial intelligence for data-driven analysis of high throughput molecular and clinical information. It is a methodology in extracting actionable insights from disparate and unmanageably large data sets. As an innovator in precision medicine, BERG has been employing AI in its work towards the discovery of novel predictive and prognostic biomarkers in oncology and neurology.
For additional information, please visit http://www.berghealth.com.