SPL.ASX: Positive DEP HER2-Lu preclinical data support Phase 1 entry

Positive DEP HER2-Lu preclinical data support Phase 1 entry

Stock	Starpharma Holdings Ltd (SPL.ASX)
Release Time	2 Jul 2026, 9:22 a.m.
Price Sensitive	Yes

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Starpharma Announces Positive DEP HER2-Lu Preclinical Data

Key Points

Strong tumour uptake and retention with low kidney accumulation
Statistically significant anti-tumour activity and survival benefit
FDA feedback supports planned development pathway
Phase 1 study planned for H2 CY2026

Full Summary

Starpharma Holdings Ltd. announced positive preclinical data for its DEP® HER2-targeted radiotherapy candidate, DEP® HER2-lutetium (DEP® HER2-Lu). The data demonstrated strong tumour uptake and retention, low kidney accumulation, and short blood circulation time in preclinical HER2-positive cancer models. The DEP® dendrimer component improved biodistribution compared to a non-DEP® HER2-targeting construct. DEP® HER2-Lu showed statistically significant anti-tumour activity and survival benefit in preclinical models, comparable to Enhertu®. Phase 1 preparations are well advanced, with first-in-human evaluation planned for H2 CY2026. FDA feedback supports the proposed development pathway. DEP® HER2-Lu was well tolerated in preclinical studies, with no abnormal clinical findings or significant changes in haematology parameters.