BOSTON--(BUSINESS WIRE)--BPGbio, Inc., a leading AI-powered biopharma that focuses on oncology, neurology, and rare diseases, today announced that review of the Phase 2a trial in advanced, refractory pancreatic cancer patients by a Medical Advisory Board for its BPM 31510IV for Pancreatic Cancer recommends advancing the asset into a Phase 2b trial following a comprehensive analysis of data observed from a Phase 1 and completed Phase 2a clinical studies.
As a result, the Advisory Board recommends the drug candidate be further assessed as a potential first-line therapy in advanced pancreatic cancer patients in the Phase 2b trial design. BPGbio submitted their findings for presentation to a major cancer meeting in January 2024 and embarked on the necessary diligence to assess the most appropriate next steps for development.
In the Phase 2a clinical trial, BPM 31510 IV demonstrated a tolerable safety profile in advanced refractory pancreatic cancer patients with an early indication for potential clinical benefit. Prior to commencement of the Phase 2a trial, the mechanism of action of BPM 31510 was first validated by data from BPGbio’s NAi Interrogative Biology® multi omics AI platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) wherein a Warburg shift is induced by BPM 31510 to modulate mitochondrial oxidative phosphorylation in highly aggressive tumors, with a direct effect on the BCL-2 protein family.
“We are extremely encouraged to observe that BPM 31510 has demonstrated an early indication of potential clinical benefit for patients with advanced refractory pancreatic cancer,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “Pancreatic cancer is the fourth leading cause of death of all cancers with only a 10% survival rate, we are focused on assessing further development of this drug for patients and their families affected by this devastating disease.”
“Advanced pancreatic cancer patients have limited treatment options and lack of early detection often leads to advanced diagnosis in most cases, resulting in devastating impacts on the family unit,” said Madappa Kundranda, M.D., Ph.D., Chief of Division of Cancer Medicine, Banner MD Anderson Cancer Center. “Early indication from BPM 31510 data, which targets the tumor microenvironment (TME), thus far supports further study in late-stage trials with the goal of offering hope for more effective treatment for the pancreatic patient community."
Moreover, in an ambitious commitment to changing the treatment paradigm of pancreatic cancer, BPGbio has identified biomarkers for early disease diagnoses in pancreatic cancer through Project Survival®, a bold seven-year study led in collaboration with Beth Israel Medical Center/Harvard Medical School, among others. This initiative holds the promise of earlier disease diagnoses which may result in better outcomes, thereby potentially saving more lives. Project Survival® has been supported by the Alliance for Families Fighting Pancreatic Cancer (AFFPC).
About BPGbio, Inc.
BPGbio is a leading AI-powered clinical stage biopharma and diagnostics company focused on oncology, neurology, and rare diseases. The company has a deep portfolio of AI-developed pipeline of therapeutics, including several in late-stage development. BPGBio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology® Platform, protected by over 400 US and international patents; the world's largest clinically annotated non-governmental biobank; and access to the most powerful supercomputing in the world. With these tools, BPGbio is redefining how patient biology can be modeled using unbiased AI. Headquartered in Boston, the company is at the forefront of a new era in medicine, combining biology, data, and AI to transform the way we understand aging, human performance, and diagnose and treat disease. For more information, visit bpgbio.com.
