The asset is engineered to act on the EGFRvIII protein, which is commonly associated with aggressive brain tumours. Credit: Gorodenkoff / Shutterstock.

The US Food and Drug Administration (FDA) has granted clearance for an Investigational New Drug (IND) application of Adaptin Bio, to commence a Phase I trial of APTN-101 for glioblastoma (GBM).

This first-in-human trial will evaluate the safety and efficacy of APTN-101.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

It will enrol patients diagnosed with World Health Organization (WHO) Grade IV Malignant Glioma (GBM).

A new brain bispecific T cell engager (BRiTE) therapy, APTN-101 is engineered to act on the EGFRvIII protein, which is commonly associated with aggressive brain tumours.

Preclinical studies are claimed to have demonstrated APTN-101’s ability to penetrate the brain effectively, showing a greater than sevenfold increase in brain distribution and significant potential in eliminating malignant glioma tumours.

The BRiTE platform, integral to APTN-101’s development, was created by Duke University’s Department of Neurosurgery.

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.

It capitalises on T cells’ natural ability to target and destroy glioma cells with precision while navigating the brain’s complex environment.

This platform is said to have been instrumental in showcasing APTN-101’s preclinical efficacy in eliminating malignant glioma tumours across various aggressive orthotopic models.

Adaptin Bio CEO Michael Roberts said: “Our proprietary BRiTE technology harnesses the immune system’s remarkable ability to target and deliver therapeutics to specific tissues, including the brain, potentially revolutionising treatment for difficult-to-treat cancers.

“APTN-101 validates the BRiTE platform and its ability to enhance the transfer of therapeutics into the brain. We are committed to advancing this novel therapy as a new potential therapy for glioblastoma patients who desperately need new therapies.”

The company aims to develop new therapies for improving patient outcomes in difficult-to-treat cancers.