18F-Fluoromisonidazole

BRIDGEWATER, N.J., April 28, 2026 (GLOBE NEWSWIRE) -- Juniper Biosciences today announced a strategic licensing agreement with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the development of JBS-003 (18F-fluoromisonidazole, or FMISO). This first-in-class hypoxia tracer in the U.S. is the cornerstone of a new precision oncology paradigm designed to spare patients from the devastating side effects of high-dose radiation therapy. The Human Toll of "One-Size-Fits-All" Radiation In the current standard of care for HPV-positive Oropharyngeal Carcinoma (OPC), patients are subjected to a "one-size-fits-all" aggressive radiation regimen regardless of their individual tumor biology. This maximum-dose approach often results in severe, permanent morbidity—including the risk of jawbone removal (osteoradionecrosis), significant weight loss requiring feeding tubes, and long-term quality-of-life impairment. Redefining the Standard of Care: From 70 Gray to 30 Gray Radiation JBS-003 utilizes precision molecular imaging to identify tumor hypoxia, a known marker of radioresistance. By mapping these oxygen-starved regions, clinicians can, for the first time, accurately risk-stratify patients. Research indicates that approximately 75-80% of these patients have non-hypoxic tumors and may safely undergo a 67% reduction in radiation, de-escalating from the standard 70 Gray (7 weeks) to 30 Gray (3 weeks) absorbed dose of ionizing radiation. This transformation represents a significant opportunity for the healthcare system to improve clinical outcomes while reducing the high costs associated with managing long-term radiation toxicity and surgical interventions. Expanding the Precision Radiopharmaceutical Platform JBS-003 is a vital component of Juniper Biosciences’ expanding multi-indication precision platform. This partnership with MSK underscores Juniper’s commitment to building a high-value pipeline that addresses the most complex challenges in nuclear medicine. “We are excited to announce our newest clinical pipeline asset and collaboration with MSK. Using F-MISO PET imaging, we can now visualize the specific hypoxic signatures of a tumor to maintain aggressive control where it’s needed, while safely reducing radiation doses for patients with well-oxygenated tissue. This effectively minimizes toxicity and preserves long-term quality of life. We aren't just treating the cancer; we are preserving the patient’s future” said Alex Agnoletto, CEO. “This collaboration is exciting because it combines our deeply validated clinical data with a partner positioned to efficiently translate it into a regulatory pathway toward FDA approval. Together, we can accelerate the impact of this work—moving from promising clinical evidence to a scalable solution that meaningfully improves patient outcomes,” said Nancy Lee, MD, FASTRO, Vice Chair, Experimental Therapeutics, Department of Radiation Oncology; Service Chief, Head & Neck Radiation Oncology; and Service Chief, Proton Therapy, at MSK. Unveiling at the MSK Innovation Summit The strategic roadmap for JBS-003 will be officially unveiled by Alex Agnoletto during a featured presentation at the MSK Innovation with Lasting Impact Summit on May 11, 2026. This presentation will serve as a prelude to the upcoming clinical milestones as the program moves toward a target regulatory filing window in late 2029. About the JBS-003 Phase 3 Clinical Trial (NCT06563479) The ongoing Phase 3 trial is a randomized, double-blind study evaluating FMISO-selected de-escalated radiation therapy. Patients in the personalized arm receive a FMISO scan at week two; those with non-hypoxic scans are eligible for a reduced 30 Gray radiation dose, while those with positive scans continue with the standard 70 Gray regimen. The trial is expected to reach primary completion in early 2028. About Juniper Biosciences Juniper Biosciences is a cutting-edge radiopharmaceutical drug development company, with a mission to improve access to novel therapeutic and diagnostic radiopharmaceutical agents. The founding team is comprised of distinguished industry members with proven track records and deep expertise in radiochemistry and complex manufacturing. MSK has financial interests in Juniper Biosciences. CONTACT: For further information please contact: Alex Agnoletto, CEO Alex.Agnoletto@juniperbiosci.com