Starpharma Secures FDA Backing for DEP HER2 First-in-Human Trial Pathway

Starpharma Holdings Limited ( (AU:SPL) ) has issued an update.

Starpharma has received positive guidance from the U.S. FDA on the clinical development strategy and first-in-human phase 1 trial design for its DEP HER2 radiotherapy candidate, a dendrimer-based conjugate targeting HER2 receptors with a lutetium-177 payload. The FDA confirmed that patients with advanced HER2-expressing cancers who have exhausted available HER2-directed therapies represent a significant unmet medical need, reinforcing the strategic relevance of DEP HER2.

The company plans to initiate a phase 1 study in Europe in the second half of 2026 in up to 15 patients to assess safety, pharmacokinetics, biodistribution and organ radiation dosimetry, with data intended to support a subsequent U.S. IND application. FDA feedback also endorsed Starpharma’s chemistry, manufacturing and controls approach and indicated that ex-U.S. data plus the current preclinical package should be sufficient to back future U.S. trials, marking a key transition from preclinical to clinical development and potentially expanding the commercial scope of its dendrimer platform in radiotherapy.

More about Starpharma Holdings Limited

Starpharma Holdings Limited is an Australian biotechnology company focused on advancing dendrimer-based drug delivery technologies, including novel radioligand therapies. Its DEP platform underpins a pipeline of targeted oncology candidates, with a particular focus on high unmet-need cancer indications such as HER2-positive tumours in global markets.

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