Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.
- FDA supports DEP® HER2 phase 1 study design and clinical approach
- Trial targets patients with advanced HER2-expressing cancers lacking effective therapies
- Phase 1 study to begin in Europe, evaluating safety and pharmacokinetics
- FDA feedback opens door for potential Fast Track designation
- Starpharma advances radiopharmaceutical pipeline amid growing partnerships
FDA Clears Path for DEP® HER2 Clinical Trial
Starpharma (ASX:SPL) has received a significant regulatory nod from the US Food and Drug Administration (FDA) on the design and clinical development strategy for its first-in-human (FIH) phase 1 study of DEP® HER2, a novel dendrimer-based radiotherapy candidate. The FDA’s positive feedback came during a Type C guidance meeting, confirming that the company’s approach aligns with regulatory expectations and supports the planned trial start in the second half of 2026.
This endorsement is a milestone for Starpharma’s radiopharmaceutical ambitions, especially as DEP® HER2 targets a patient population with advanced HER2-expressing cancers who have exhausted existing HER2-targeted therapies. The FDA explicitly recognised the significant unmet medical need in this group, signalling potential eligibility for accelerated pathways such as Fast Track designation.
Trial Design and Regulatory Confidence
The upcoming phase 1 study will enrol up to 15 patients across European clinical sites, focusing on safety, tolerability, pharmacokinetics, biodistribution, and radiation dosimetry of DEP® HER2. Importantly, the FDA confirmed that the preclinical data package, including recently completed toxicology studies, alongside clinical data generated outside the US, should suffice to support future US-based trials under an Investigational New Drug (IND) application.
Starpharma’s manufacturing and quality control processes for DEP® HER2 also received FDA agreement, reflecting confidence in the company’s dendrimer-based radioligand therapy platform. Professor Tony Lahoutte, a nuclear medicine expert from University Hospital Brussel, who advised Starpharma and participated in the FDA meeting, highlighted that the trial design is well positioned to demonstrate the clinical benefits of the dendrimer delivery system in this high-need patient population.
Strategic Implications Amid Pipeline Progress
DEP® HER2 represents a key strategic asset for Starpharma as it seeks to expand its footprint in the growing radiotherapy market. The company’s CEO Cheryl Maley emphasised the significance of the FDA feedback in providing regulatory clarity and confidence to transition from preclinical to clinical development. This progress dovetails with Starpharma’s broader momentum, including recent financial gains and partnerships, such as the lucrative Genentech deal that contributed to a $1.37 million profit in H1 FY26 and underpinned pipeline advancement DEP® HER2 radiopharmaceutical program advancing.
Starpharma is finalising clinical site selection and preparing radiopharmacy and regulatory approvals to maintain its timeline. The company’s dendrimer technology, known for its nanoscale precision and polyvalency, continues to show promise in targeted delivery, potentially broadening therapeutic applications beyond current indications.
While the FDA’s endorsement is encouraging, the true test lies ahead in clinical trial outcomes and subsequent regulatory milestones, particularly for US market entry. The industry will be watching how Starpharma navigates these next steps in a competitive oncology landscape.
Bottom Line?
Starpharma’s FDA alignment on DEP® HER2’s phase 1 trial sets the stage for clinical validation of its dendrimer radiotherapy platform, but clinical results will ultimately determine its trajectory.
Questions in the middle?
- Will DEP® HER2 secure Fast Track designation based on unmet need recognition?
- How will clinical trial data influence Starpharma’s US IND submission timeline?
- Can dendrimer technology deliver a competitive edge in targeted radiotherapy?