Radiopharm’s New HER2 Radiotherapy Faces Clinical and Market Challenges Ahead
Radiopharm Theranostics has initiated dosing in its Phase 1 HEAT trial of 177Lu-RAD202, a novel radiotherapeutic aimed at advanced HER2-positive solid tumors, marking a key step in its clinical development.
- First patient dosed in Phase 1 HEAT trial of 177Lu-RAD202
- Trial focuses on safety, tolerability, and dose optimization for HER2-positive cancers
- RAD202 is a proprietary nanobody targeting HER2 in multiple solid tumors
- Previous diagnostic studies demonstrated safety and biodistribution of RAD202
- Trial conducted across Australian clinical centers including St John of God Murdoch Hospital
A Milestone in Radiopharmaceutical Oncology
Radiopharm Theranostics has reached a significant milestone with the dosing of the first patient in its Phase 1 HEAT trial, investigating 177Lu-RAD202, a novel radiotherapeutic designed to target HER2-positive advanced solid tumors. This marks the company’s transition into a clinical-stage biopharmaceutical entity, underscoring its commitment to addressing unmet needs in oncology.
Targeting HER2 – A Validated but Challenging Frontier
HER2 overexpression is a well-established driver in breast cancer and several other solid tumors, making it a critical target for therapeutic intervention. Despite advances in managing metastatic HER2-positive disease, many patients eventually experience progression or intolerance to existing treatments. RAD202, a proprietary single domain antibody or nanobody, offers a fresh approach by delivering targeted radiation directly to HER2-expressing cancer cells, potentially improving outcomes while preserving quality of life.
Trial Design and Early Promise
The HEAT trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, and optimal dosing of 177Lu-RAD202 ahead of Phase 2 development. It also aims to capture early signals of clinical activity in patients with advanced HER2-positive cancers. The trial builds on prior diagnostic studies where RAD202 demonstrated favorable safety and biodistribution profiles in humans, providing a strong foundation for therapeutic exploration.
Collaborative Clinical Efforts in Australia
Clinical centers across Australia, including St John of God Murdoch Hospital, are participating in this trial. Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at the hospital, highlighted the potential of 177Lu-RAD202 to open new therapeutic avenues for aggressive tumor types beyond breast cancer, such as ovarian, gastric, pancreatic, and bladder cancers.
Looking Ahead
With this first dosing, Radiopharm Theranostics sets the stage for further clinical evaluation of RAD202’s potential to become a meaningful treatment option for patients with limited alternatives. The company’s broader pipeline, spanning peptides, small molecules, and monoclonal antibodies, positions it well within the competitive radiopharmaceutical oncology landscape.
Bottom Line?
As Radiopharm advances RAD202 through early clinical testing, the oncology community watches closely for signs of a new weapon against HER2-positive cancers.
Questions in the middle?
- What safety and efficacy signals will emerge from the ongoing HEAT trial?
- How quickly can Radiopharm progress to Phase 2 and potentially pivotal studies?
- What competitive advantages might RAD202 hold over existing HER2-targeted therapies?
