Adaptin Bio has received FDA clearance to initiate a Phase 1 clinical trial for its investigational drug APTN-101, a novel therapy for glioblastoma (GBM).

APTN-101 utilizes proprietary BRiTE (Brain Bispecific T cell Engager) technology to target EGFRvIII, a protein commonly associated with aggressive brain tumors. Preclinical studies have demonstrated its efficacy in eradicating malignant glioma tumors.

The clinical trial will evaluate APTN-101’s safety and efficacy in patients with WHO Grade IV Malignant Glioma, including GBM. Despite current treatment options such as surgery and chemotherapy, GBM remains highly challenging, with a median survival rate of only 12-18 months and a low long-term survival rate.

The blood-brain barrier poses a significant challenge in treating brain tumors, as it blocks the delivery of many therapies. APTN-101’s ability to cross this barrier and target glioma cells directly presents a promising new approach.

Michael J. Roberts, CEO of Adaptin Bio, expressed enthusiasm for the trial. He emphasized their commitment to advancing APTN-101 as a potential game-changer for GBM patients.

Mustafa Khasraw, M.D., Professor at Duke University, highlighted the promising preclinical data and the potential of APTN-101 to address the unmet medical need in GBM treatment.

Adaptin Bio’s innovative delivery technology aims to revolutionize cancer and central nervous system disorder treatment. The initiation of the clinical trial marks a significant step forward in their mission to translate groundbreaking technologies into new therapeutic options for patients in need.

Source link: http://www.businesswire.com/news/home/20240905978578/en/Adaptin-Bio-Announces-FDA-Clearance-of-IND-Application-for-APTN-101-in-Glioblastoma

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.