CHARLOTTE, N.C. — Adaptin Bio, Inc. (“Adaptin” or the “Company”), a biotechnology company developing precision cancer therapeutics enabled by targeted delivery to the brain and other difficult-to-reach tissues, today announced that the Preston Robert Tisch Brain Tumor Center has granted the first Institutional Review Board (IRB) approval for the Company’s Phase 1 first-in-human clinical trial evaluating APTN-101 in the treatment of glioblastoma multiforme (GBM).
“Following the successful preclinical development and acceptance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), we are extremely pleased to receive our first IRB approval for APTN-101’s Phase I clinical trial,” said Michael J. Roberts, Ph.D., Chief Executive Officer of Adaptin Bio. “This represents a major inflection point for our lead program and validates the translation readiness of our targeted bispecific antibody platform. In collaboration with Duke University investigators, the inventors of our BRiTE platform, APTN-101 demonstrated compelling anti-tumor activity and a favorable safety profile in multiple preclinical models. With clinical, manufacturing, and regulatory foundations now in place, we are positioned to advance APTN-101 into the clinic and work toward delivering a meaningful new therapeutic option for patients facing a devastating disease.”
Glioblastoma multiforme, classified as a World Health Organization (WHO) Grade IV malignant glioma, is the most aggressive and lethal primary brain tumor. Despite decades of research, standard-of-care treatment (surgical resection followed by radiation and chemotherapy) remains largely palliative, with median survival of approximately 14–16 months and five-year survival rates below 10%. More than 12,000 new cases are diagnosed annually in the United States alone, underscoring the urgent unmet medical need for innovative therapeutic approaches. A primary obstacle to progress in GBM and other central nervous system (CNS) diseases is the blood-brain barrier (BBB), which prevents most biologics and immune therapies from reaching therapeutic concentrations within the brain, severely limiting their clinical efficacy.
Adaptin’s BRiTE (Brain Bispecific T cell Engager) platform is designed to overcome this fundamental limitation by enabling efficient and selective delivery of immune-engaging biologics across the BBB. APTN-101 leverages this platform to transport a potent T-cell–redirecting bispecific antibody into the brain, where it can recruit and activate cytotoxic T cells directly at the tumor site. By enabling immune effector cells to penetrate the CNS and engage malignant cells in situ, APTN-101 is designed to address both the immune-privileged nature of the brain and the infiltrative biology of GBM, offering the potential for deeper, more durable anti-tumor responses than existing therapies.
Beyond glioblastoma, Adaptin believes its BBB-penetrant immune delivery approach has broad applicability across multiple CNS oncology and neurology indications, representing estimated billion-dollar-plus market opportunities. The global glioma treatment market alone is projected to reach approximately $4.4 billion, with significant expansion potential as effective targeted and immunotherapeutic strategies become clinically viable. Adaptin plans to leverage the BRiTE platform to build a pipeline of brain-directed immunotherapies aimed at transforming outcomes for patients with currently intractable CNS diseases.
About APTN-101 BRiTE Therapeutic
Adaptin Bio’s proprietary brain bispecific T cell engager, APTN-101, leverages the enhanced “hitchhiking” capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. The novel approach has demonstrated high specificity for EGFRvIII-expressing glioma cells, dose-responsive efficacy against diverse patient-derived glioma cell lines, and a favorable safety profile. By manipulating the immune system either in vivo or ex vivo, BRiTE aims to overcome traditional treatment barriers and offer a promising new therapeutic option for patients with intracerebral malignancies.
About Adaptin Bio, Inc.
Adaptin Bio, Inc. is a biotechnology company developing novel therapies for oncology and central nervous system disorders. Its mission is to improve patient outcomes in difficult-to-treat cancers by improving and enhancing drug delivery to the brain and other tissues. The Company’s proprietary Brain Bispecific T cell Engager (BRiTE) technology, powering investigational cancer therapeutic APTN-101, was developed by researchers at the Department of Neurosurgery at Duke University. APTN-101 is FDA-cleared for a Phase 1 clinical trial in glioblastoma (GBM), and other indications are being considered for future studies. For more information, visit www.adaptinbio.com.
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