Bold Therapeutics has plans to expand a Phase Ib/IIa BOLD-100-001 clinical trial of its therapy, BOLD-100, along with 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) chemotherapy for advanced gastric, pancreatic, colorectal and bile duct cancer patients in the US.

The US Food and Drug Administration (FDA) has approved Bold Therapeutics’ investigational new drug (IND) application amendment for the trial, permitting the addition of US trial centres.

The BOLD-100-001 trial will initially commence at H Lee Moffitt Cancer Center & Research Institute in Tampa, Florida; and the University of California, Los Angeles.

A ruthenium-based small molecule treatment, BOLD-100 modifies the unfolded protein response by selectively hindering GRP78. It also stimulates reactive oxygen species which leads to deoxyribonucleic acid damage and halts the cell cycle.

These effects together cause cell death in sensitive and resistant cancers.

The mechanism offers BOLD-100 the potential to substantially enhance outcomes in various solid and liquid tumours when given with other cancer treatments such as standard chemotherapies, targeted therapies and immuno-oncology agents.

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The two-stage, open-label, multi-centre BOLD-100-001 study will assess the safety and efficacy of BOLD-100 in combination with FOLFOX chemotherapy.

The trial is currently recruiting subjects at six trial centres in Canada.

Bold Therapeutics Clinical Development executive vice-president Jim Pankovich said: “This FDA clearance is a major milestone for Bold Therapeutics as it allows us to more rapidly enrol patients and further diversify our patient population.

“Our corporate mission is to address significant unmet needs in oncology, and we are optimistic that BOLD-100 can meaningfully improve outcomes in patients with these difficult-to-treat cancers.”

The company concluded a Phase I monotherapy trial of the therapy in 46 subjects with advanced solid tumours.

Data from the trial showed a robust safety profile for BOLD-100, which was well-tolerated with less hematologic and neurologic side effects.

Bold Therapeutics has also partnered with Western University Schulich Medicine & Dentistry associate professor Dr Stephen Barr to analyse BOLD-100 against SARS-CoV-2 variants of concern.

In April 2021, Bold Therapeutics reported that BOLD-100 consistently reduced viral concentrations in several variants of Covid-19, including the B.1.1.7 variant originally identified in the UK.