Aankondiging • Apr 20
Radiopharm Theranostics Presents Initial Findings from Phase 1 First-In-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026 Radiopharm Theranostics announced that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California. 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile in the lowest dose cohort. The Data Safety and Monitoring Committee recently approved advancing 177Lu-RAD202 to the next highest dose at 130 mCi. The AACR poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi. Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions. 177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events. No dose-limiting toxicities or treatment discontinuations due to adverse events were observed. Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation. On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee to advance 177Lu-RAD202 to the third cohort at a dose level of 130 mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors. 177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density. The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155)) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors. Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose. Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose. RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution. Aankondiging • Apr 08
Radiopharm Theranostics Advances 177Lu-Rad202 to Next Dose Level in Phase 1 Clinical Trial Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation. The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia. The announcement of the previous dose level in this study of 75mCi was released on 1 October 2025. Aankondiging • Mar 27
Radiopharm Theranostics Doses First Patient in Phase 1 Clinical Study of RAD 402 in Advanced Prostate Cancer Radiopharm Theranostics announced that the first patient has been dosed in its first-in-human Phase 1 clinical trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161 being evaluated in advanced prostate cancer. The Phase 1 clinical trial (NCT07259213) is designed to study the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) for expansion. Targeting KLK3 and leveraging the dual emission of Tb161 represents an innovative approach for radiotherapies in Prostate Cancer. Preclinical proof-of-concept mouse xenografts demonstrated RAD 402’s strong tumor targeting with minimal bone/marrow uptake and expected hepatic clearance. RAD 402 (NCT07259213) is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb that is being evaluated in a Phase 1/2a clinical trial for the treatment of prostate cancer. Prostate Specific Antigen (PSA) is a widely used biomarker to detect prostate cancer and is encoded by the KLK3 gene. KLK3 is highly expressed in prostate cancer cells along with most adenocarcinomas of the prostate including their metastases and has limited expression in sites outside of the prostrate. Preclinical proof-of-concept biodistribution studies of 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. Aankondiging • Mar 24
Radiopharm Theranostics Limited Achieves Primary Endpoint In 90% Of Patients At Second Interim Analysis Of RAD101 Phase 2b Imaging Trial In Brain Metastases Radiopharm Theranostics Limited announced the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm's novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging. They measure an imaging test's ability to correctly identify patients with a disease (sensitivity, true positive rate), as well as patients without the disease (specificity, true negative rate). RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease. In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care. The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment na ve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies. Aankondiging • Feb 24
Radiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01) Radiopharm Theranostics announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01). The Phase 1/2a clinical trials is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBART, along with its preliminary anti-tumor activity. The trial will also determine the recommended dose of 177Lu-BetaB art for future studies. This agent was developed by Radiopharm Ventures, a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Center. 177Lu-Betabart is a Lu177-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. In preclinical studies, 177Lu-BetaBart has shown evidence of efficacy and targeting of the specific 4Ig isoform ofB7-H3, supporting its potential use in multiple indications, including prostate, pancreatic, breast and other solid tumors. RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Venture, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MDAnderson Cancer Center. RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of177Lu-Betabart (RV-01). The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma. Aankondiging • Dec 17
Radiopharm Theranostics Limited has filed a Follow-on Equity Offering. Radiopharm Theranostics Limited has filed a Follow-on Equity Offering.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: Subsequent Direct Listing 
