ASCO 2015: Berg presents data from BPM 31510 Phase Ib trial for solid tumors

Jun 2 2015

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological approach, presented clinical research from its trials using its cancer drug BPM 31510 on Phase Ib solid tumors and preclinical data on triple negative breast cancer, at the 51^st Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29 – June 2 in Chicago.

BPM 31510 is one of the first cancer drugs guided in development by artificial intelligence. It works by reprogramming the metabolism of cancer cells, or reversing the Warburg effect, re-teaching them to undergo cell death. Data from preclinical and human trials indicate BPM 31510 as a single-agent treatment leads to tumor regression and clinical benefits and increases antitumor activity in combination with chemotherapy agents.

The Phase Ib trial is being performed under lead investigators Manish Shah, MD, Director of GI Oncology at Cornell Weill Medical Center, Ralph G. Zinner, MD, Investigator, Associate Professor at MD Anderson Cancer Center, and Peter Yu, MD, Investigator at Palo Alto Medical Foundation and President of ASCO.

"BPM31510 used alone and in combination with chemotherapy in an ongoing dose escalation Phase Ib trial has been well tolerated with minimal toxicity across multiple dose levels," said Dr. Ralph G. Zinner, Associate Professor, Investigator, MD Anderson Cancer Center. "We have also seen antitumor activity alone and in combination with chemotherapy. PET scan and CT scan findings are matched against voluminous omics done in matched pre- and -post tumor and blood samples. We have preliminary evidence that BPM31510 modulates patterns of markers in predictable and mechanistically plausible ways. This encourages further ongoing efforts to develop this highly elaborate artificial intelligence driven set of analyses of omics with the hope we can one day use it as a powerful tool to detect early response progression and toxicity. The study has not yet reached an MTD and continues to accrue patients."

Berg, the namesake of Chairman and Co-founder Carl E. Berg, merges biology with Bayesian artificial intelligence to understand patient populations as a foundation to creating the next generation of drugs and diagnostics. At ASCO, Berg Co-Founder, President and Chief Technology Officer, demonstrated the company's approach to drug discovery and capabilities, including its proprietary Interrogative Biology™ Platform, which engages the biology and targets disease at the cellular level while also uncovering a deeper understanding of the disease.

"Berg's revolutionary drug BPM31510 has been engineered to battle some of the most deadly cancers, including highly metabolic tumors where our goal is long-term survival," said Niven R. Narain. "Using the Interrogative Biology™ platform, we are focused on a new drug development paradigm where patients can be treated with therapies that match the biology of their disease rather than the current one-size-fits-all approach. By continuing to take a precision medicine approach to drug development, Berg is poised to lead the effort in creating the right treatment for a specific patient a reality."

Berg will assess on-going data from the Phase Ib trial and use the stratified patient outcome data to plan for multiple Phase II trials in highly metabolic tumors within the next year.