FYR Bio and NuvOx Therapeutics Secure $1.98M NCI Grant to Advance Liquid Biopsy Technology in Glioblastoma Trial
核心洞察
FYR Bio (搜索) and NuvOx Therapeutics (搜索) received a two-year $1,976,897 Direct-to-Phase II SBIR award from the National Cancer Institute to integrate liquid biopsy technology into glioblastoma (搜索) treatment.
The collaboration will apply FYR's EV-Omics platform to NuvOx's Phase IIb RESTORE trial testing NanO₂ (搜索), a radiosensitizer designed to reverse tumor hypoxia (搜索) in glioblastoma (搜索) patients.
The partnership aims to develop extracellular vesicle biomarkers that can help clinicians differentiate pseudoprogression from true tumor progression, addressing a persistent challenge in glioblastoma (搜索) management.
FYR Bio (搜索), a leader in liquid-biopsy precision medicine for neuro-oncology, has partnered with NuvOx Therapeutics (搜索) to advance biomarker development in glioblastoma (搜索) treatment through a substantial National Cancer Institute grant. The two-year $1,976,897 Direct-to-Phase II Small Business Innovation Research (SBIR) award will enable integration of FYR's extracellular vesicle-based liquid biopsy technology into NuvOx's ongoing Phase IIb glioblastoma trial.
Addressing Critical Challenges in Glioblastoma Management
The collaboration, titled "Liquid Biopsy in Glioblastoma (搜索) Treated with Chemoradiation and an Oxygen Therapeutic," targets two fundamental challenges in glioblastoma (GBM (搜索)) treatment: distinguishing pseudoprogression from true tumor progression and addressing tumor hypoxia (搜索) that drives treatment resistance.
Under the grant, FYR will apply its EV-Omics™ (EVO) platform and SPARCs™ enrichment technology to longitudinal blood samples collected in NuvOx's RESTORE trial. The trial is testing NanO₂ (搜索)™, a radiosensitizer designed to reverse tumor hypoxia (搜索) in glioblastoma (搜索) patients receiving chemoradiation therapy.
"Our goal is to help drug development companies de-risk their programs and increase the likelihood of clinical trial success, clarifying who benefits, when, and why," said Katie Havranek, Ph.D., Director of Research & Development at FYR. "Building on FYR's neuro-oncology experience and prior insights in GBM (搜索), this collaboration explores EV biomarkers that may strengthen endpoints, refine patient selection, and guide the next phase of NuvOx's clinical strategy."
Novel Approach to Biomarker Discovery
The collaboration will explore extracellular vesicle (EV) biomarkers that reflect hypoxia (搜索) biology, correlate with treatment exposure, and help clinicians differentiate pseudoprogression from true progression—a persistent challenge in GBM (搜索) management. FYR will perform EV-based proteomic and transcriptomic analyses from plasma collected at prespecified timepoints to discover and evaluate hypoxia-related biomarkers and progression-state classifiers.
Pseudoprogression after chemoradiation is common in GBM (搜索) and can resemble true progression on MRI imaging. Better differentiation between these conditions could reduce unnecessary treatment changes and improve patient care. Meanwhile, hypoxia (搜索) drives radioresistance in GBM, making NanO₂ (搜索)'s approach to counteract this biology particularly relevant for improving treatment outcomes.
NanO₂'s Clinical Development Progress
NuvOx's drug candidate NanO₂ (搜索) represents a potentially disruptive platform technology addressing multiple unmet medical needs. The oxygen therapeutic has demonstrated positive results in two completed Phase Ib/II studies: one in glioblastoma (搜索) as a radiosensitizer and another in stroke (搜索) as a neuroprotectant. In a comprehensive literature review, NanO₂ was identified as the most promising oxygen therapeutic among 74 clinical-stage compounds.
The therapeutic has accumulated safety and efficacy data across more than seven indications in various preclinical and clinical stages. NanO₂ (搜索) has received Orphan Drug Designation for both glioblastoma (搜索) and sickle cell anemia (搜索), and safety data is available from approximately 2,000 subjects. The product is designed to work synergistically with standard of care treatments rather than competing with existing therapies.
Expanding Clinical Pipeline
NuvOx is currently conducting multiple clinical trials with NanO₂ (搜索). Beyond the Phase IIb RESTORE trial in glioblastoma (搜索), the company has initiated a Phase IIb clinical trial for NanO₂ in acute ischemic stroke (搜索) treatment, funded by the UK government. Additionally, NuvOx is conducting a Phase Ib clinical trial for NanO₂ in respiratory distress treatment.
The company maintains a robust intellectual property portfolio with 11 patent families, 11 issued US patents, and 31 foreign equivalents, providing comprehensive protection for its oxygen therapeutic platform.
Technology Integration and Future Implications
FYR's EVO platform leverages proprietary SPARCs™ technology to enrich for extracellular vesicles from diseased cells, enabling assessment of cellular proteins and nucleic acids from peripheral blood samples. The platform utilizes AI-enabled multiomic insights to unravel disease mechanism complexity, potentially transforming personalized patient care from screening through therapy selection and monitoring.
The insights generated from this collaboration are intended to support NuvOx's therapeutic development and inform potential future trial design and strategy. By generating multiomic insights that inform patient management, FYR aims to de-risk NuvOx's program and enhance future trial design.
This research is supported by the National Cancer Institute of the National Institutes of Health under Award Number 1R44CA298498-01A1, representing a significant investment in advancing precision medicine approaches for one of the most challenging brain cancers.