Radiopharm Theranostics Ltd is a Australian based clinical-stage radiotherapeutics company which is targeting cancer. The company has a pipeline of around four licensed platform technologies, with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development. The company is engaged in research, development and commercialisation of health technologies.
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- Interim Phase 2b data show 18F-RAD101 PET achieved 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint in suspected recurrent brain metastases. - Among 14 patients with evaluable six-month follow-up or biopsy data, RAD101 demonstrated preliminary 86% sensitivity for identifying recurrent disease, a secondary objective. - The findings were selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), November 12-15, 2026, in Philadelphia. - Radiopharm plans to meet with the FDA on October 1, 2026, to align on a pivotal global Phase 3 protocol, with Siemens Healthineers supplying 18F-labeled RAD101 doses.
- Radiopharm Theranostics has increased its ownership in Radiopharm Ventures from 75% to 87.5%, reflecting confidence in the joint venture's cancer therapeutic pipeline progress. - The lead candidate Betabart, a monoclonal antibody targeting B7H3 radiolabeled with 177Lu, received FDA IND clearance and represents the first clinical trial globally targeting B7H3 with a systemic radiopharmaceutical. - The Phase I therapeutic trial for multiple solid tumors is expected to dose its first patient in Q1 2026, with multiple centers already activated. - Two additional preclinical candidates from Radiopharm Ventures have demonstrated early positive results and are progressing toward final candidate selection in 2026.
- Radiopharm Theranostics has received Bellberry Human Research Ethics Committee approval in Australia to initiate a first-in-human Phase 1 clinical trial of RAD 402 for metastatic or locally advanced prostate cancer. - RAD 402 is an anti-KLK3 monoclonal antibody radiolabeled with terbium-161, representing what the company believes is the first company-sponsored therapeutic trial using this radionuclide. - Preclinical biodistribution studies in mouse xenografts demonstrated strong tumor targeting, limited bone and marrow uptake, and appropriate hepatic excretion profile for the monoclonal antibody. - The therapy targets KLK3, which encodes prostate specific antigen and is expressed in prostate adenocarcinomas and their metastases, offering a novel mechanism of action through dual emission of beta particles and Auger electrons.
- Radiopharm Theranostics has appointed Dr. Oliver Sartor, an internationally recognized medical oncologist specializing in prostate cancer and radiopharmaceutical therapies, to its Scientific Advisory Board. - Dr. Sartor currently serves as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic and has led multiple pivotal Phase 3 trials resulting in FDA approvals for radiopharmaceutical therapies. - The appointment strengthens Radiopharm's clinical expertise as the company advances its radiopharmaceutical pipeline, which includes one Phase 2 and three Phase 1 trials across various solid tumor cancers.
- Data Safety Monitoring Committee has approved continuation of Radiopharm's Phase 1 trial for 177Lu-RAD204, allowing progression to a higher dose cohort without protocol modifications. - The PD-L1-targeting radiotherapeutic is being developed for multiple advanced solid tumor types, potentially expanding treatment options for patients with limited therapeutic alternatives. - Radiopharm has simultaneously strengthened its financial position with a US$5 million investment from Lantheus Holdings, which increased its stake to 12.16% and will support advancement of the company's clinical pipeline.
- Radiopharm Theranostics' imaging molecule RAD 101 successfully detected brain metastases in all 22 patients during an observational trial, including both treatment-naïve and previously treated individuals. - The innovative approach combines 18F-RAD101 with PET-mpMRI technology to target fatty acid metabolism in solid tumors, potentially offering improved diagnostic accuracy over current standard-of-care methods. - Results have prompted advancement to a Phase IIb trial (NCT06777433) to evaluate 18F-RAD101's performance in patients with suspected recurrent brain metastases, addressing a market expected to reach $34.3bn by 2027.
Radiopharm Theranostics has entered into a strategic partnership with Lantheus to advance radiopharmaceutical development in Australia, with an initial focus on a Phase 1 imaging trial for multiple solid tumors. The collaboration includes up to USD 2 million in milestone payments for Radiopharm, with Lantheus covering all clinical development costs.
- Radiopharm Theranostics has received ethics approval in Australia to begin a Phase 1 trial of 177Lu-RAD202 in HER2-expressing solid tumors. - The Phase 1 'HEAT' trial will assess the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202 in advanced cancer patients. - Previous data in breast cancer patients showed the safety of 177Lu-RAD202, validating its potential for treating HER2-expressing cancers. - Preclinical studies demonstrated tumor growth inhibition and prolonged survival with 177Lu-RAD202, supporting its further clinical development.
- Radiopharm Theranostics is nearing FDA approval for its BetaBart radiotherapeutic agent, targeting the B7-H3 protein in tumors. - Pre-clinical trials in animals showed BetaBart effectively shrank tumors and improved survival rates, prompting a pre-IND meeting with the FDA. - BetaBart, developed with MD Anderson Cancer Centre, is designed for Phase 1 and 2 human trials in the US, potentially starting mid-next year. - Radiopharm's technology uses antibodies to deliver targeted radioactive doses to tumor cells, offering a precise approach to cancer treatment.
- Radiopharm Theranostics has expanded its strategic research collaboration with GenesisCare to conduct Phase I trials of three radiopharmaceutical candidates targeting hard-to-treat cancers in Australia. - The trials will evaluate a PDL-1 targeting nano-mAb for non-small cell lung cancer, a PTPu targeting peptide for brain tumors, and a PSA targeting antibody for prostate cancer. - Radiopharmaceuticals deliver small doses of radiation to specifically targeted cells for therapeutic or diagnostic purposes, offering new hope to patients who have exhausted other treatment options. - The two-year collaboration leverages GenesisCare's contract research organization capabilities across its 440+ locations in Australia, UK, US, and Spain.
