Our pipeline

Read more about our clinical trials below

Nano-mAbs Clinical Trials

HER-2 PHASE 1 BREAST IMAGING COMPLETE

Phase 1 imaging has been completed on 33 patients with Technetium-99m in Shanghai and Germany

Non-invasive and demonstrated safety
Accumulation / high uptake in target within 2 hours post injection
Acceptable biodistribution and dosimetry (renal protection can be achieved by standard pre-injection of gelufusin/amino acids mixture)
Shows clear intra and inter-tumoural heterogeneity of HER-2 expression
Provide more accurate and informative information on HER-2 cancers in comparison to existing IHC / FISH detections from biopsy samples
Potential to be used for whole body assessment and treatment of HER-2+ cancers with different medical radioisotopes

HER-2 PHASE 1 BREAST THERAPEUTIC COMMENCING

Phase 1 therapeutic about to launch in late stage HER-2+ breast cancer in Germany with Re-188 and Lu-177
Can be easily adopted as a therapeutic with Lu-177 or Ac-225
High probability of success as a therapeutic agent
Patient safety data
Same targeting as imaging but just change of war-head ( Tc-99m to Re-188, or Ga-68 to Lu-177 )
Re- and Tc- structural and reaction chemistry is the “same” – easy conversion
Apply to patients with good images and dosimetry – see then treat

PD-L1 PHASE 1 NON SMALL CELL LUNG CANCER IMAGING HAS BEEN COMPLETED ON 40 PATIENTS

PD-L1 is a pan-cancer biomarker and immuno-checkpoint blockers are becoming the most important treatment of multiple cancers
Imaging technology is licensed to Lantheus for research collaborations in diagnostic imaging
Worldwide exclusive license to Radioharm Theranostics for therapeutic use
Imaging done on 40 NSCLC patients in Shanghai General and at Kings College London
Approved for Phase 2 Imaging Clinical Trial by MHRA
DMF for Imaging filed with FDA in US
Easily adopted for therapeutic use
High probability of success as therapeutic agent
Patients safety data; same cold kit as imaging but just change of war-head
Apply to patients with good images – see then treat

**Specific uptake in primary tumour and metastatic lesions**

Pivalate Clinical Trials

Pivalate Phase 1

Imaging complete in cerebral metastases, glioma, kidney, solid tumors

Pivalate Phase 2

In cerebral metastases, glioma interim positive data summary below

AVβ6 Integrin Clinical Trials

AVβ6 BEST-IN-CLASS : PHASE 1a COMMENCED

Biodistribution generally (Healthy subject comparison)

*None of Radiopharm Theranositcs’ product pipeline has received marketing authorization in any jurisdiction. Any use of Radiopharm Theranostic products is on an investigational basis or for use in approved clinical trials.
‍

Animal testing is a regulatory requirement to ensure that new pharmaceutical products are safe and effective in humans. At Radiopharm Theranostics, we value the contribution that animals make to science and take animal welfare very seriously. As a result, we only conduct animal testing in countries where the highest animal welfare standards are enshrined in law and where animal welfare and ethical standards in research facilities are constantly monitored by an impartial ethics committee or a relevant authority. Thus, we only work with carefully selected partners in the European Union, USA, UK and Australia.In our research, we are strongly committed to upholding the 4Rs of animal research:

Replacement: we continuously seek regulatory advice to allow for the substitution of animal studies with in vitro alternatives.
Reduction: whenever possible, we use novel molecular imaging technology in our animal studies instead of conventional methods and this enables us to reduce the number of animals by 50 to 80%.
Refinement: we seek to minimise distress to research animals and, as part of our commitment to Replacement, seek to replace the most distressing studies when possible.
Responsibility: we proudly accept responsibility for animals in our studies and actively engage with our partner organisations conducting research on our behalf."

Company Pipeline - 180 patients dosed