The US Food and Drug Administration (FDA) has granted clearance for Strand Therapeutics’ investigational new drug (IND) application to begin a Phase I clinical trial of STX-001 for solid tumours.
STX-001 is a programmable messenger ribonucleic acid (mRNA) therapy designed to enhance the efficacy of existing immunotherapies for solid tumours.
The first-in-human trial will evaluate STX-001, which uses synthetic self-replicating mRNA technology to express the interleukin-12 (IL-12) cytokine within the tumour microenvironment for longer periods.
STX-001 operates on a multi-mechanistic approach that kills immunogenic cancer cells and boosts the recruitment and activation of T cells and NK cells in the tumour microenvironment.
It is thought that this approach could improve clinical responses in solid tumour treatments.
Preclinical data suggest that STX-001 could overcome the limitations of current immunotherapy options.
The therapy has shown the potential to deliver therapeutic quantities of IL-12 more effectively than standard mRNA, as well as elicit a lasting anti-tumour response when given in conjunction with programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) checkpoint inhibitors.
STX-001 is the first therapy from Strand's solid tumour platform, which can express any protein therapeutics directly within the tumour cells, creating previously unachievable therapeutic indices.
Strand Therapeutics CEO and co-founder Jake Becraft said: “We are thrilled to receive IND clearance to advance our programme into patients, which represents an important milestone for our company.
“STX-001 represents a promising new approach for the treatment of solid tumours. We’re excited to continue evaluating our programmable mRNA technology across a number of therapeutic areas.”
Strand Therapeutics is a biotechnology company based in Boston, Massachusetts, and focuses on the development of first-in-class programmable mRNA therapeutics.
It plans to create enhanced treatment options for cancer and other life-threatening ailments, using mRNA technology to control the expression of therapeutic proteins within the body.
