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.

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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.

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

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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.