Cizzle Bio Submits NIH Grant Proposal with Premier Research Institutions to Advance Biomarker Blood Test for Lung Cancer

SAN ANTONIO, July 8, 2025 /PRNewswire/ -- Cizzle Bio, Inc., a biotechnology company pioneering innovative biomarker blood tests for early detection of lung and gastric cancers, has submitted a grant application to the National Institutes of Health (NIH), in partnership with two top-tier research institutions, to support a two-year study validating its CIZ1B biomarker for early-stage lung cancer detection.

The NIH proposal is a major step in Cizzle Bio's mission to address a critical unmet need in oncology — detecting lung cancer before symptoms appear. Lung cancer is the leading cause of cancer-related deaths in the United States and globally, due in large part to diagnoses occurring at late stages of the disease.

If approved, the study will use pre-diagnostic and longitudinal blood plasma samples from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a landmark biorepository managed by the National Cancer Institute (NCI). The PLCO biobank includes tens of thousands of blood samples collected from high-risk individuals years before any cancer diagnosis, offering a rare opportunity to determine whether the CIZ1B biomarker can detect lung cancer prior to clinical symptoms. By analyzing CIZ1B expression in these early samples, researchers aim to validate its accuracy in predicting disease onset.

The proposed study will analyze a large cohort of 1,730 lung cancer cases to evaluate CIZ1B performance across age, gender, ethnicity, smoking history, and other demographic and behavioral subgroups. Researchers will also investigate whether early biomarker changes are associated with more aggressive forms of the disease and assess detection accuracy across different lung cancer histological subtypes. A key objective is to identify the optimal window for detection and determine how far in advance the biomarker can signal the onset of cancer before clinical diagnosis.

"CIZ1B has demonstrated high sensitivity and specificity in earlier studies of Stage 1 lung cancer, which were conducted by Cizzle Biotechnology at the University of York in the UK," said William Dalton, Ph.D., M.D., senior consultant for clinical trials at Cizzle Bio. "By validating it in pre-symptomatic patients using longitudinal biobank samples, we are moving closer to a practical and scalable early-detection solution—one that could dramatically shift outcomes for patients at high risk."

The study will be conducted in collaboration with two world-class institutions, the Florida Institute for Human and Machine Cognition (IHMC) and the Southwest Research Institute (SwRI). IHMC will lead the development of deep learning models to correlate biomarker expression with cancer onset, leveraging its state-of-the-art computational biology infrastructure and access to the University of Florida's HiPerGator supercomputer.

"Advancing the human condition is at the core of IHMC's scientific mission," said IHMC Chief Executive Officer Morley Stone, Ph.D. "We are looking forward to partnering with Cizzle Bio and Southwest Research Institute to lend our expertise to this important proposal."

SwRI will provide analytical and laboratory expertise in biomarker assay validation, bringing decades of experience in regulated biopharmaceutical development and diagnostics.

"This NIH submission reflects our commitment to scientific rigor and data-driven innovation," said Bill Behnke, founder and CEO of Cizzle Bio. "With the proposed support from IHMC, SwRI, and the NIH, we aim to build the evidence needed to advance a clinically validated, low-cost blood test to the front lines of lung cancer screening."

Low-dose CT (LDCT) is the recommended lung cancer screening method, but it carries a high false-positive rate. The CIZ1B test is a minimally invasive, high-throughput ELISA assay that is well-suited for routine clinical use and scalable across healthcare settings.

The study is designed to build on strong preliminary evidence and is expected to demonstrate the potential role of CIZ1B in filling a critical gap in early lung cancer detection, enabling earlier intervention to improve patient outcomes. Beyond the clinical impact, broad adoption of the CIZ1B test could lead to substantial healthcare savings by helping reduce the high costs associated with treating late-stage lung cancer, an important consideration for Medicare and other major payers.

Cizzle Bio anticipates a response from the NIH later this year. The company continues to expand its network of clinical, research, and health system partners to accelerate the path toward near-term market entry and widespread clinical use, ensuring that its blood-based diagnostics reach the patients who need them most.

About Cizzle Bio, Inc.

Cizzle Bio is a Texas-based biotechnology company dedicated to revolutionizing cancer diagnostics by pioneering biomarker-based blood tests, starting with early detection of lung and gastric cancers. Our goal is to empower patients, equip clinicians, and improve outcomes through innovation, compassion, and life-saving solutions. We hold exclusive licensing rights for our groundbreaking CIZ1B biomarker test in the United States, Canada, and the Caribbean and a worldwide exclusive license for our DEX-G2 biomarker gastric cancer test. Cizzle Bio is commercializing both tests for U.S. clinical environments.
www.cizzlebio.com

About the Florida Institute for Human and Machine Cognition (IHMC)

The Florida Institute for Human and Machine Cognition (IHMC) is an independent not-for-profit research institute of the State University System of Florida with over 160,000 feet of research and administrative space across four buildings (three in Pensacola, Florida; one in Ocala, Florida). IHMC has grown into one of the nation's premier research institutes with multiple university and industry affiliations and more than 100 researchers and staff pioneering technologies aimed at leveraging and extending human capabilities.
www.ihmc.us

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SOURCE Cizzle Bio