Radiopharm Theranostics

Quarterly Activities & Cash Report and 4C for the Quarter ended 30 September 2024

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world‐class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to provide a summary of its activities for the quarter ended 30 September 2024.


  • First patient dosed in Phase 1 therapeutic RAD204 Non‐Small Cell Lung Cancer trial
  • FDA IND approval received for RAD101 Phase 2b brain metastases trial
  • Dr Dimitris Voliotis appointed as Chief Medical Officer
  • Increase in ownership of Radiopharm Ventures to 75%
  • ADR program launched for US investors

FIRST PATIENT DOSED WITH PD-L1 NANOBODY IN PHASE 1 THERAPEUTIC NON-SMALL CELL LUNG CANCER TRIAL

Early in the quarter Radiopharm dosed the first patient in its Phase 1 clinical trial for RAD204, a nanobody targeting PD‐L1 in patients with metastatic Non‐Small Cell Lung Cancer (NSCLC). The trial is being conducted at several hospitals in Australia, including Wollongong Hospital, and is designed to evaluate the safety and tolerability of 177Lu‐RAD204. This follows a Phase 1 diagnostic study in 16 patients that confirmed RAD204's safety and effective biodistribution, laying the foundation for its potential as a treatment for advanced NSCLC.

The study is aimed at addressing the need for additional therapeutic options for patients with metastatic NSCLC who have progressed after first‐line treatment. Radiopharm's CEO, Riccardo Canevari, emphasised the importance of providing alternative strategies for these patients, with the goal of improving clinical outcomes while maintaining quality of life.

The trial is part of Radiopharm's broader development program focused on radiopharmaceuticals for cancer treatment, with a pipeline that includes various platform technologies such as peptides, small molecules, and monoclonal antibodies.

RADIOPHARM THERANOSTICS RECEIVES FDA IND APPROVAL FOR PHASE 2B IMAGING TRIAL IN BRAIN METASTASES

In July, Radiopharm received approval from the US FDA for its Investigational New Drug (IND) application for F18‐Pivalate (RAD101), a proprietary imaging agent aimed at detecting brain metastases. Pivalate is a small molecule labelled with the radioisotope F18 that targets short chain fatty acids, a protein overexpressed in brain tumors. This approval allows Radiopharm to proceed with a Phase 2b multi‐center trial to evaluate RAD 101 in brain metastases, with the first patient expected to be dosed in the fourth quarter of 2024.

The trial will enrol 30 patients, with results expected by mid‐2025. The study builds on positive data from a Phase 2a trial conducted by Imperial College of London in 17 patients, which demonstrated significant tumor uptake in patients with brain metastases. Following the Phase 2b trial, Radiopharm plans to initiate a Phase 3 registrational study.


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This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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