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FDA Grants Breakthrough Therapy Designation to JBS-003 for Guiding De-escalated Radiotherapy in HPV-Positive Oropharyngeal Cancer

On September 1, Juniper Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its hypoxia tracer JBS-003. The product, 18F-Fluoromisonidazole (FMISO), is intended to identify tumor hypoxia and guide de-escalated radiotherapy in patients with HPV-positive oropharyngeal cancer (OPC). JBS-003 is licensed from Memorial Sloan Kettering Cancer Center (MSK). According to information released by the company, the tracer is based on F-MISO PET molecular imaging technology and can visualize specific hypoxic features within tumors. Tumor hypoxia is considered to be associated with radioresistance; by imaging hypoxic regions, clinicians can stratify patients by risk and...

2026-09-02

Molecular Partners Advances DLL3 Radiopharmaceutical MP0712 to Higher Dose Cohort

Swiss clinical-stage biotechnology company Molecular Partners AG recently announced its business progress and financial results for the first half of 2026. The company stated that its DLL3-targeting radioactive DARPin therapy MP0712 has advanced to the second therapeutic dose level in a U.S. multicenter Phase 1/2a clinical study, and patient enrollment for the new dose cohort is currently underway. MP0712 is a radiopharmaceutical targeting the tumor-associated antigen DLL3, carrying a therapeutic alpha-emitting radionuclide lead-212 (Pb-212) payload, co-developed by Molecular Partners and Orano Med, primarily for small cell lung cancer and other neuroendocrine tumors. According to the company's disclosure, the first dose cohort of MP0712...

2026-08-26