Sparks - Starpharma

As part of its latest CEO presentation, Starpharma has confirmed that its first human Phase I study of DEP HER2-Lu, its lead targeted radiotherapy for HER2 expressing cancers, is expected to commence in December CY26, subject to regulatory and ethics approval. The clinical trial application remains under review, with site preparations progressing at University Medical Center Groningen in the Netherlands. Clinical manufacturing has advanced, with production of the nonradioactive precursor and validation of the radiolabelling process completed.

Management expects initial data from the first three to four patients in H1 CY27, followed by a final Phase I readout from up to 15 patients in H2 CY27. The study will assess safety and tumour targeting, building on encouraging preclinical results showing sustained tumour retention and low kidney exposure. A further FDA meeting is planned for H1 CY27, ahead of a broader Phase I/II study involving up to 40 patients, which is expected to commence in H2 CY27. Looking further ahead, Starpharma is targeting readiness for a pivotal Phase II/III study in CY28, potentially involving up to 250 patients, with an accelerated approval pathway remaining a possibility subject to future clinical results and regulatory discussions.