ASCO15 EXCLUSIVE: Berg’s Lead Cancer Drug May Shift Cancer Metabolism, Says CEO
June 3, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Biological research biopharma Berg’s data presented at this week’s meeting of the American Society of Clinical Oncology is a promising sign that the cancer metabolism as an exciting and viable approach to treating cancer, Niven R. Narain, co-founder, president and chief technology officer of Berg, told BioSpace exclusively on Wednesday
Berg presented clinical research from its trials using its experimental cancer drug BPM 31510 on Phase Ib solid tumors and preclinical data on triple negative breast cancer, at ASCO. That data from preclinical and human trials showed BPM 31510 as a single-agent treatment leads to tumor regression and clinical benefits and increases antitumor activity in combination with chemotherapy agents.
"The data from the on-going Phase Ib trial suggest that BPM 31510 has the ability to shift the metabolism of advanced, highly metabolic tumors back to that of ‘behaving like a normal cell,’” Berg told BioSpace. “It allows the tumor microenvironment to support the cell death processes necessary to induce an anti-cancer effect. Moreover, the drug is well tolerated in a very sick patient population with minimal side effects and combines well with chemotherapy which allows for potential use many cancer indications given the broad spectrum mechanism of action on high metabolic tumors."
BPM 31510 has garnered a lot of notice for being one of the first cancer drugs guided in development by artificial intelligence. Narain said it works by “reprogramming” the metabolism of cancer cells, or “reversing the Warburg effect, re-teaching them to undergo cell death.”
"The results thus far suggest more broad options in multiple tumor types given the mechanism. Moreover, the ability to combine with other therapies and approaches, allow us as industry to tackle cancer in a multi-prong approach,” said Narain. “More horsepower against the disease will lead to increase overall survival, which at the end of the day is the gold standard, and should be the goal of everyone involved. I applaud FDA for concentration on survival, there is no use in getting a ‘tumor effect’ with the patient surviving only months.”
BPM 31510 targets the microenvironment of the tumor and “normalizes” the molecular architecture allowing cancer to behave like a normal cell. “Keeping tumors localized, preventing metastases, and maintaining organ function will keep patients alive--that is the ultimate goal of Berg’s approach to cancer," said Narain.
In April the company said it hopes to roll its lead cancer drug, BPM 31510, into Phase II clinical trials for metastatic pancreatic cancer at more than 48 Pancreatic Cancer Research Team (PCRT) sites around the world.
"The real significance highlights cancer metabolism as an exciting and viable approach to treating cancer and we envision potential synergies with immunotherapies which may lead to potential cures and render cancer a chronic disease in some settings,” said Narain. “There is real hope for patients with these approaches and with the right collaborations between companies and groups, the appropriately designed trials may lead to much higher success rates clinically and further allow collaboration with regulators to advance treatments to patients in an expedient manner."
Berg’s Phase Ib trial is being performed under lead investigators Manish Shah, director of GI Oncology at Cornell Weill Medical Center, Ralph G. Zinner, associate professor at MD Anderson Cancer Center, and Peter Yu, investigator at Palo Alto Medical Foundation and president of ASCO.
"Berg is in the process of finalizing our Phase II development plan with leading institutions and oncologists around the U.S. and world, such as PCRT and others,” Narain told BioSpace. “We intend to launch Phase I/II and Phase II trials in multiple indications over the next year and seek breakthrough designation/accelerated approvals in some areas of unmet need and orphan designation. We will be enrolling in a diverse geographical context within the US so patients will have access across the country – this is important to us."
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?