Memorial Sloan Kettering Cancer Center shared on LinkedIn:
“Memorial Sloan Kettering Cancer Center (MSK) is pleased to share that Juniper Biosciences, a key licensing partner, received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for JBS-003 (18F-fluoromisonidazole, or FMISO), a first-in-class hypoxia tracer.
JBS-003 is a radiopharmaceutical used for the identification of tumor hypoxia to guide de-escalated radiation therapy in patients with HPV-positive Oropharyngeal Carcinoma (OPC). Earlier this year, MSK licensed to Juniper the clinical trial data supporting its use.
FMISO is the cornerstone of a new precision oncology paradigm designed to spare patients from the devastating side effects of high-dose radiation therapy.
As a leader in molecular imaging, MSK pioneered the use of hypoxia tracers to overcome the limitations of traditional imaging.
FMISO is a key element in Juniper’s pipeline of promising products addressing complex challenges in nuclear medicine.
FDA Breakthrough Therapy Designation is reserved for programs intended to address a serious condition where preliminary clinical evidence indicates the potential for substantial improvement over available therapy on a clinically significant endpoint.
Clinical data generated by MSK played a key role in enabling Juniper to achieve this important breakthrough, including both foundational research by our Radiation Oncology and Medical Physics teams and earlier phases of Juniper clinical trials conducted at MSK.
As an important next step in the goal of bringing this breakthrough technology to patients, MSK is conducting a Phase 3 clinical trial (NCT06563479).
This trial will test FMISO in a randomized, double-blind study evaluating FMISO-selected de-escalated radiation therapy.
‘We are excited that the FDA has granted Breakthrough Therapy designation, and we look forward to completing this Phase 3 trial and generating the pivotal evidence needed to support potential FDA approval,‘ says Dr. Nancy Y. Lee, a radiation oncologist and Service Chief for Head and Neck Oncology at MSK.”
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