BPGbio has dosed the first patients in a Phase II clinical trial of BPM 31510 to treat Glioblastoma Multiforme (GBM), an aggressive form of brain cancer.

Stanford Medicine Neuro-Oncology Division clinical associate professor Seema Nagpal is leading the open-label, multi-cohort study.

The study will also be carried out at Mt Sinai Medical Center in New York and Cedars-Sinai Medical Center in Los Angeles.

In addition, BPGbio is assessing additional US and UK clinical sites for potential participation.

The Phase II study will have primary, secondary, and exploratory endpoints, as well as planned interim analyses.

Developed using the AI-driven Interrogative Biology platform of BPGbio, BPM 31510 targets mitochondrial machinery and the microenvironment of tumour cells and creates a metabolic shift, thereby leading to the death of cancer cells.

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Significant long-term survival was observed in preclinical orthotopic models of GBM pre-treated with BPM 31510 followed by radiation therapy, compared to radiation alone.

An anti-cancer effect in GBM patients without damage to the normal cells of the brain was also observed in preclinical studies.

A favourable safety profile of BPM 31510 was seen in a Phase I trial of advanced, refractory GBM patients conducted at Stanford Medicine.

BPGbio president and CEO Niven Narain said: “This milestone is a testament to the value of our Interrogative Biology platform and its capability to develop drugs for the treatment of deadly diseases, where patients desperately need better therapeutics.

“Advancing this candidate into Phase II human trials is a big step of progress for both the company and patients suffering from GBM.”