Starpharma brings DEP HER2-Lu closer to first patient dosing

DEP HER2-Lu reaches regulatory submission stage

Starpharma Holdings Limited (ASX:SPL) has moved its lead radiopharmaceutical program to the edge of human testing, submitting a Clinical Trial Application in Europe for a first-in-human Phase 1 study of DEP HER2-Lu. The application was lodged after the September quarter through the European Union’s clinical trials system, with the study planned at University Medical Center Groningen in the Netherlands.

The company also completed manufacture of the non-radiolabelled clinical material during the quarter and progressed the radiolabelling process, analytical work and quality-control activities. The initial study is designed to assess safety and tolerability, while measuring tumour uptake, biodistribution, pharmacokinetics and radiation dosimetry in patients with HER2-expressing cancers. First patient dosing remains conditional on regulatory approval and site start-up.

Capital raise funds a broader oncology push

The clinical advance is backed by a materially stronger balance sheet. Starpharma completed its AUD $32 million fully underwritten entitlement offer in August, following the

Cash and cash equivalents stood at AUD $34.4 million at 30 September, after operating cash use of AUD $5.9 million for the quarter. Including an AUD $3.5 million research and development tax incentive received on 22 October, pro forma cash was AUD $37.9 million. The Appendix 4C calculation puts total available funding at AUD $34.7 million, including unused facilities, or about 5.9 quarters at the quarter’s operating cash outflow rate.

Petalion stake gives Starpharma control of FAP program

Starpharma has also expanded its control of the oncology pipeline. Following quarter end, it lifted its interest in Petalion Therapeutics from 22.5% to 66%, securing majority ownership, governance control and operational leadership of the FAP-targeted DEP program. Medicxi retains a 30% interest, board representation and an active strategic role.

Starpharma will contribute up to AUD $5 million to Petalion, comprising AUD $3 million in cash and up to AUD $2 million in research and development services. The program is developing a FAP-targeted dendrimer-drug conjugate, with the next stage focused on selecting a lead candidate and defining its development and partnering pathway.

Radiopharm option remains a conditional commercial catalyst

The company received an AUD $0.5 million option fee from Radiopharm Theranostics (ASX:RAD, NASDAQ: RADX) in July after reaching a collaboration milestone. The payment moved the program into an option period during which Radiopharm may elect to take an exclusive licence to Starpharma’s DEP dendrimer technology for a radiopharmaceutical asset.

Any larger commercial return remains contingent on that election. If Radiopharm exercises the option, Starpharma says it could receive up to AUD $91 million in upfront and milestone payments, plus royalties on net sales. Meanwhile, research under the Genentech collaboration continues and Starpharma has filed a patent application covering DEP technology in radioligand therapy across targets including HER2, PSMA and EGFR.