STX-001 is a programmable mRNA therapy designed to treat patients with solid tumours. Credit: Pixel-Shot / Shutterstock.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

Preclinical data suggest that STX-001 could overcome the limitations of current immunotherapy options.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. 

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.