– Sunbird’s proprietary blood-based diagnostic approach classified tau-PET positive blood samples with a correlation of 92% to gold standard PET scans –

– Results shared at the Alzheimer’s Association International Conference^® (AAIC^®) –

Sunbird Bio, a biotechnology company developing proprietary blood-based technologies to improve diagnosis and treatment of neurological disorders and early-stage cancer, today announced new data demonstrating that the company’s proprietary blood-biomarker tau signatures have the potential to accurately detect tau aggregation in the brain from a simple blood draw. Results from the study, which will be shared in a poster presentation (#88533) on Tuesday, July 30 at the Alzheimer’s Association International Conference^® (AAIC^®), suggest that Sunbird’s technology could provide blood-based Alzheimer’s disease diagnosis equivalent to the gold-standard positron emission tomography (PET) imaging.

Alzheimer's disease is marked by the accumulation of misfolded and aggregated proteins in the brain, notably amyloid beta (Aβ) and tau, leading to cognitive decline. In Alzheimer's, tau becomes hyperphosphorylated, misfolding and forming tangles within neurons, disrupting their function and contributing to their degeneration. When aggregated tau proteins bind to nanoscale extracellular vesicles (EVs) in the brain, scarce levels are able to pass through the blood-brain barrier into the bloodstream. These EV-bound particles are difficult for most blood tests to accurately detect.

“Our research continues to reveal the power of EV-bound proteins to serve as accurate biomarkers in the detection of neurological disorders, and the data we are presenting at AAIC underscore the promising potential of our blood-based diagnostic to directly detect Alzheimer’s disease via these particular tau proteins,” said John McDonough, executive chairman and CEO of Sunbird Bio. “With a correlation of 92% to the gold standard PET scan, these data provide further evidence that our proprietary approach may deliver a diagnostic that improves patient outcomes in Alzheimer’s disease and other neurological disorders. We will continue to evaluate this platform, which could provide researchers and physicians with unparalleled insights not readily available from current tests.”

The Sunbird Bio study being shared at AAIC 2024 evaluated the potential of EV-bound tau and phosphorylated tau (pTau) proteins in the blood as a method of directly detecting tau aggregation in the brain. Researchers prospectively collected blood samples from 10 individuals who were tau-PET positive, as well as from 22 age-matched healthy individuals, at four global sites. They then used Sunbird Bio’s proprietary tau assays to distinguish between EV-bound and unbound soluble forms of tau in plasma. Results suggest that a signature composed of unbound soluble tau was unable to classify PET-positive samples, while a signature composed of blood-based brain EV-bound tau and pTau accurately classified tau-PET positive samples with an area under the curve (AUC) of 0.92. These findings suggest that Sunbird Bio’s proprietary blood-biomarker signatures, consisting of multiple forms of tau bound to specific types of brain-derived EVs, have the potential to accurately and directly detect tau aggregation in the brain via a blood test.

“Understanding about the various protein biomarkers involved in the diagnosis of Alzheimer’s disease and other neurological disorders is growing rapidly, and we are proud that our blood-based diagnostic panel is at the forefront of this promising area of discovery,” said Nicholas Ho, Ph.D., co-founder and director, innovation of Sunbird Bio. “In particular, our team is leading the way in the exploration of EV-bound proteins and their ability to transmit critical insights from the brain that allow us to directly detect in blood the existence of protein aggregation and therefore, the presence of disease. We will continue to investigate the applications of this increasingly important biomarker, among others, that offers a direct window into the pathological processes that occur in the brain to improve diagnosis and treatment.”

Sunbird Bio’s blood-based diagnostic platform is designed to overcome the limitations of PET, cerebrospinal fluid (CSF)-based tests and other blood-based diagnostics, which have drawbacks that limit their usefulness in drug development, disease detection, disease monitoring and personalized treatment selection. This first-of-its-kind technology uses a proprietary sensor platform and optical amplification to directly detect and measure very low concentrations of EV-bound, aggregated proteins in blood. The company plans to initiate a larger clinical study to further validate its tau blood-biomarker signatures and has an active pipeline that includes blood-based tests for Aβ, tau, alpha synuclein (α-synuclein), TDP-43 and other biomarkers for neurological diseases.

Sunbird Bio is actively securing partnerships with biopharma companies and others to accelerate the development of its blood-based diagnostic platform and conduct clinical studies; use cases include longitudinal monitoring, patient stratification and target engagement.

About Sunbird Bio

Sunbird Bio is a biotechnology company developing proprietary blood-based diagnostic tests that provide unprecedented insights to enable earlier, more accurate diagnosis and treatment of neurological disorders and early-stage cancer. Sunbird’s innovative technologies uniquely detect the property and activity of proteins to empower researchers and clinicians with actionable information that is not available or accessible from current tests. Sunbird Bio’s unparalleled leadership in blood-based diagnostics positions the company to become a global leader in the field, addressing significant research and clinical gaps, and serving multiple, sizable markets. For more information, please visit sunbirdbio.com.

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