Clinical trial testing BPM31510 for glioblastoma now fully enrolled
Therapy aims to 'reprogram tumor metabolism' in fast-progressing glioma
Enrollment is now complete in a Phase 2b clinical trial testing Bpgbio’s BPM31510, a treatment candidate for glioblastoma multiforme (GBM), a rapidly progressing type of glioma, the developer has announced.
The clinical trial (NCT04752813) is evaluating the safety and tolerability, as well as the effectiveness, of BPM31510 combined with vitamin K1 in adults newly diagnosed with GBM. It’s now enrolled 50 people across 11 study sites in the U.S., according to a company press release.
“This milestone represents not just the completion of enrollment, but real progress in advancing a therapy designed to reprogram tumor metabolism,” said Niven R. Narain, PhD, president and CEO of Bpgbio. Tumor metabolism refers to the way cancerous cells produce energy and eliminate toxic substances.
While the company awaits top-line data in the first half of 2026, it plans to present interim data at two medical meetings later this year, per the release.
For Vijay Modur, MD, PhD, chief medical officer of Bpgbio, the trial’s full enrollment is “a testament to the strong collaboration with our clinical sites and the enthusiasm within the community for advances in GBM, an area of research that has not seen major therapeutic innovation in decades.”
GBM is an aggressive type of glioma, a cancer that forms when glial, or supportive, cells of the brain begin to grow uncontrollably. Treatment usually involves surgery to remove as much of the tumor as possible, followed by radiation therapy and chemotherapy.
However, even after these lines of treatment, many patients see their cancer return.
US trial has enrolled 50 people with glioblastoma multiforme
BPM31510 contains ubidecarenone — also known as coenzyme Q10, it’s a vitamin-like molecule that is part of the body’s energy-producing machinery in mitochondria, which serve as the powerhouses of cells. The ubidecarenone is packaged into very small particles called nanoliposomes, which are evenly dispersed in a fluid solution
Cancer cells typically rely more on aerobic glycolysis — a fast but less efficient way of producing energy — and are often resistant to apoptosis, a form of controlled cell death. BPM31510 is designed to deliver high amounts of coenzyme Q10 into tumor mitochondria, increasing reactive oxygen species, or highly toxic molecules, and driving cancer cells toward apoptosis.
In a preclinical study, rats with glioma grown from human cancer cells lived longer when treated with BPM31510 compared with a placebo.
“BPM31510 has shown the ability to prolong survival in animal models,” Modur said, also noting activity seen in human GBM cell systems.
“These findings provide strong scientific rationale as we move forward in evaluating [BPM31510’s] potential,” Modur said.
BPM31510 has shown the ability to prolong survival in animal models. … These findings provide strong scientific rationale as we move forward in evaluating its potential.
In a Phase 1 clinical trial (NCT03020602) involving 12 patients with difficult-to-treat glioma, the therapy was shown to be safe and well tolerated when used alongside vitamin K1.
Now, the company is investigating whether reprogramming tumor metabolism can make GBM more responsive to radiation and chemotherapy.
BPM31510 granted orphan drug status for treatment of GBM
The main goal of the already underway, open-label, Phase 2b clinical trial is to measure progression-free survival at six months in newly diagnosed patients. Progression-free survival refers to how long patients live without their cancer getting worse.
Participants will receive BPM31510 as a once-weekly, intravenous, or into-the-vein, infusion for eight weeks.
Vitamin K1 will be given as an injection subcutaneously, or under the skin, before each infusion. After two weeks, patients will start standard radiation therapy and daily chemotherapy with temozolomide for 42 days, followed by up to 12 cycles of temozolomide after treatment with BPM31510.
“We are grateful to the patients and families who have participated in our clinical trial,” Narain said. “We are eager to see how BPM31510 can translate into meaningful benefit for patients with GBM.”
BPM31510 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of GBM. This designation offers benefits, such as tax incentives and potential market exclusivity, to encourage development of potential treatments for rare diseases.
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