Juniper Biosciences has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for JBS-003 (18F-fluoromisonidazole or FMISO), a hypoxia tracer being developed to guide reduced radiation therapy in patients with HPV-positive oropharyngeal carcinoma (OPC).

JBS-003, licensed from Memorial Sloan Kettering Cancer Center (MSK), uses molecular imaging to identify areas of low oxygen, or hypoxia, within tumours. Tumour hypoxia is associated with resistance to radiation treatment. The technology is intended to help doctors identify patients who may be suitable for lower radiation doses while maintaining standard treatment for patients with hypoxic tumours.

The Breakthrough Therapy Designation is intended for therapies for serious conditions where early clinical evidence suggests a potential for significant improvement over existing treatments. The designation for JBS-003 is supported by clinical evidence from FMISO-guided radiation de-escalation studies, including research conducted at MSK and the company's ongoing clinical programme.

The designation provides Juniper with increased interaction with the FDA during development and may support an accelerated regulatory process, including rolling submission and priority review eligibility.

The current standard treatment for HPV-positive OPC involves high-dose radiation, which can cause long-term side effects. These may include damage to the jawbone, significant weight loss requiring feeding tubes and lasting effects on quality of life.

JBS-003 is designed to identify tumour hypoxia through FMISO positron emission tomography (PET) imaging. Research suggests that around 80% of patients with HPV-positive OPC may have non-hypoxic tumours and could potentially receive a reduced radiation dose. The investigational approach reduces radiation from the standard 70 Gray (Gy) to 30 Gy for selected patients.

JBS-003 forms part of Juniper Biosciences' precision oncology platform, which is being developed across multiple indications. The company plans to work with the FDA to establish the development and regulatory pathway for the programme.

An ongoing Phase 3 randomised, double-blind trial is evaluating FMISO-guided radiation de-escalation. Patients in the personalised treatment group undergo an FMISO scan during the second week of treatment. Those with non-hypoxic tumours may receive 30 Gy of radiation, while patients with hypoxic tumours continue with the standard 70 Gy regimen.

The Phase 3 study is expected to reach primary completion in early 2028. The results are intended to provide pivotal evidence to support the potential regulatory approval of JBS-003.

 

Source: globenewswire.com

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