Program and Business Updates
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
RAD 101 is being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel imaging small molecule to the over 300,000 patients diagnosed annually in the U.S. with cerebral metastases. The study is currently enrolling patients and anticipates completing enrollment in the first quarter of 2026.
177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177
The Company continues to evaluate RAD 202 in the Phase 1 ‘HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with positive safety and biodistribution and was recently recommended by the Data Safety and Monitoring Committee (DSMC) to progress to the next dose level of 75mCi in the ‘HEAT' trial.
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177
RAD 204 is continuing to be evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer. Previous Phase 1 imaging data of 16 NSCLC patients treated with RAD 204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry.
Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177
RV 01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a Joint Venture between Radiopharm Theranostics and the MD Anderson Cancer Center.
Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161
RAD 402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical studies, RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
Ga68-RAD301 – Peptide targeting αvB-integrin radiolabeled with Gallium 68
RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of the Company's decision to move to a Phase 2 imaging trial in patients with loco-regional pancreatic cancer.
The unmet medical need in the earlier stage of disease and the larger disease prevalence compared to the patient population of the current Phase 1 trial have influenced the decision to evaluate RAD 301 in loco-regional pancreatic cancer.