Starpharma sets December target for first human HER2 radiopharmaceutical trial

DEP HER2-Lu approaches first human dosing

Starpharma Holdings Limited (ASX:SPL, US OTC:SPHRY) is targeting December 2026 for the first-in-human study of DEP HER2-Lu, its lead radiopharmaceutical candidate, although the timetable remains conditional on ethics approval. The program has completed manufacture of its non-radiolabelled dendrimer precursor, while radiolabelling, quality-control and process-validation work for the Phase 1 study has also been completed.

The company said its European clinical trial application was under review and that site preparations were continuing with University Medical Center Groningen in the Netherlands. A regulatory pathway is also being developed in the United States, with an FDA Type C meeting completed and a Type B pre-IND meeting planned for the first half of calendar 2027. The company expects an initial readout from roughly three to four patients in the first half of 2027 and topline data from up to 15 patients in the second half, subject to the study proceeding as planned.

That timetable builds on the DEP HER2-Lu trial preparations described in Starpharma’s European trial application announcement last month, which also reported completed clinical-material manufacture. The AGM presentation’s preclinical evidence showed strong tumour uptake and retention, low kidney exposure and anti-tumour activity in HER2-high tumour-bearing mice. Those findings are early animal data, not evidence of clinical efficacy, and the planned Phase 1 study is intended to assess targeting, biodistribution, dosimetry, safety and tolerability.

Oncology focus backed by fresh capital

“DEP® HER2-lutetium Schematic”

Starpharma’s strategic reset is now explicit: the company says it is concentrating its dendrimer platform on targeted oncology, particularly radiopharmaceuticals, while retaining partnerships and marketed consumer-health products as additional commercial pathways. The model combines proprietary assets such as DEP HER2-Lu with external collaborations that can generate research revenue, upfront payments, milestones and royalties.

That strategy is supported by a net A$30 million entitlement offer, which the Chair’s address said achieved approximately 99% uptake. Starpharma reported a pro forma cash balance of A$37.9 million at 30 September 2026, including the A$3.5 million R&D tax incentive, and said the funds extend its runway into FY28. The raise was previously earmarked for the DEP HER2-Lu Phase 1 study and further oncology development, giving the financing a direct link to the company’s most important near-term clinical milestone.

Petalion stake increases exposure to FAP program

Starpharma has also increased its ownership of Petalion Therapeutics from 22.5% to 66%, taking majority control of the FAP-targeted dendrimer-drug conjugate program. Medicxi remains a strategic shareholder with a 30% stake, while Starpharma said up to A$5 million would support the program, including A$3 million in cash allocated from the capital raise.

The next stated steps are lead-candidate selection and completion of the preclinical program, with an IND-enabling path targeted over the next 12 months. The company describes FAP as a pan-cancer target, but the program remains preclinical and its commercial potential has not been established in human studies.

Partnerships add validation and contingent upside

Starpharma highlighted its Genentech collaboration as a major achievement of FY26. The agreement gives Genentech an exclusive worldwide licence under Starpharma’s intellectual property for products arising from the collaboration, with Genentech responsible for development and commercialisation. Starpharma received an A$8.3 million upfront payment and is eligible for tiered royalties and success-based milestones; the company’s materials refer inconsistently to total milestone potential of A$804 million in the Chair’s address and A$806 million in the presentation.

The company also pointed to its Radiopharm Theranostics research and option agreement, as well as its DEP SN38 and DEP cabazitaxel assets, as evidence of a broader partnering pipeline. Such payments remain contingent on development, commercial and contractual outcomes rather than representing committed future revenue.

Chair transition comes as execution phase begins

Rob Thomas is stepping down as Chair after 12 years, subject to shareholder approval, and has nominated Dr Russell Basser as his successor. Thomas said he expected to remain on the board as a director and support the transition, while Dr Jeff Davies is listed as incoming Deputy Chair.

For Starpharma, the leadership change arrives alongside a demanding execution phase: ethics approval and first patient dosing for DEP HER2-Lu, early clinical data, lead selection for the FAP program and further partnering activity are all flagged through 2027 and beyond. The central test is no longer whether the DEP platform can attract interest, but whether the company can convert that interest and its preclinical claims into clinical evidence without outrunning its cash runway.