Value Proposition: 18F-FMISO (fluoromisonidazole)
First‑in‑class diagnostic delivering confidence to safely halve radiation doses for most patients.
Programs Designed to
Transform Patient Outcomes
Balancing clinically proven solutions with novel theranostics across multiple disease states.
| Candidate | Target | Isotope | Pre-Clinical | Phase I | Phase II | Phase III | Reg. Filing |
|---|---|---|---|---|---|---|---|
| JBS-002 Undisclosed | PSMA | 68-Ga |
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| JBS-003 (F-MISO) HPV+ Head and Neck Cancer | Hypoxic Tumor Cells | 18-F |
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| JBS-004 Undisclosed | Undisclosed - within Alzheimer's disease | 18-F |
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| JBS-005 α Undisclosed | Undisclosed | Undisc. α-emitter |
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| JBS-005 β Undisclosed | Undisclosed | Undisc. β-emitter |
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| JBS-005 γ Undisclosed | Undisclosed | Undisc. PET-emitter |
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Ending Over-treatment in
HPV+ Head & Neck Cancer
18F-FMISO PET imaging identifies which patients truly need high-dose radiation — and which can safely receive half the dose with comparable cure rates and dramatically better quality of life.
Data and images property of Memorial Sloan Kettering Cancer Center - see journal publication at: https://jnm.snmjournals.org/content/jnumed/65/10/1526.full.pdf.
First-in-Class F-18 PET Hypoxia Mapping for HPV+ Oropharynx Head & Neck Cancer
Enabling External Beam Radiation Dose De-escalation for Better Patient Outcomes
Phase III
Clinical Trial
Est. 80%
Of patients overtreated under current standard of care
~20k
New US oropharyngeal cancer cases annually
Memorial Sloan Kettering
Research Location
The Solution
Ending 80% Overtreatment
Blind SoC Radiation Causes Permanent, Unnecessary Morbidity
Standard of
Care Limitations
Current SoC forces toxic maximum-dose radiation on 100% of patients despite 80% having non-hypoxic, de-escalation-ready tumors.
Unmet Need:
Risk Stratification
Clinicians lack a validated molecular tool for precision risk-stratification that can guide therapy adjustments
Orphan Epidemiology
(US): Oropharyngeal Cancer
~20k new incident patients annually
Imaging Volume: Universal Clinical Utility
Most diagnosed patients can benefit from precise stratification to tailor treatment and minimize radiation and toxicity.
Lower Radiation Dose Levels Significantly Improve Patient Safety and QoL
Data and images property of Memorial Sloan Kettering Cancer Center.
Data and images property of Memorial Sloan Kettering Cancer Center.
Data and images property of Memorial Sloan Kettering Cancer Center.
Precedented
Mechanistic Relevance
Precedented Mechanistic Relevance
Used since late 1980s in EU and ROW. Deepest dataset of any hypoxia tracer. Clears in well-oxygenated cells. Becomes trapped in oxygen-starved tumors, enabling visualization on PET
Current 70Gy SoC: Side effects to surrounding tissue
- Often removal of jawbone sections & significant amount of tissue
- 20+ lbs of weight loss and long recovery time.
Future 30Gy For Hypoxia Negative Patients
- Cure rates comparable to 70Gy dose levels
- Less likely to require jaw resection or major tissue loss.
- Less weight loss
Recognition of Innovation
Tumor Hypoxia on 18F-fluoromisonidazole Positron Emission Tomography and Distant Metastasis From Head and Neck Squamous Cell Carcinoma
A Novel Approach to Treatment Optimization of Head and Neck Cancer
Data and images property of Memorial Sloan Kettering Cancer Center - see journal publication at: https://jnm.snmjournals.org/content/65/10/1526/tab-figures-data.
Disclosure
Expanded Access — Fluoromisonidazole F 18 ([¹⁸F]-FMISO)
Memorial Sloan Kettering Cancer Center (MSK) sponsors the clinical development of [¹⁸F]-FMISO, an investigational PET imaging drug being studied in patients with HPV-associated oropharyngeal cancer. Juniper Biosciences, Inc. holds an exclusive license for its commercial development.
At this time, MSK and Juniper are not offering expanded access to [¹⁸F]-FMISO. The drug is being evaluated in an ongoing Phase 3 clinical trial in a limited patient population, and enrollment in that trial is the appropriate route of access. Providing the drug outside the trial could interfere with completing the study needed to support FDA approval and make the drug available to all patients. This stance will be reviewed as the program advances and may be revised at any time.
Contact and requests: Physicians may direct expanded access inquiries or requests to Dr. Nancy Lee. We expect to acknowledge receipt within 15 business days.
General evaluation criteria: Should this change, requests would be evaluated based on (1) the seriousness of the patient’s condition and the absence of comparable or satisfactory alternatives; (2) ineligibility for, or inability to access, the ongoing clinical trial; (3) the adequacy of drug supply and the treating site’s PET imaging and radiopharmaceutical-handling capabilities; and (4) whether providing access could interfere with the clinical trials or regulatory review needed to bring the drug to market.
Clinical trial information: https://clinicaltrials.gov/study/NCT06563479
Posting of this stance does not guarantee access to [¹⁸F]-FMISO. Consistent with the 21st Century Cures Act, this stance may be revised at any time.
