Shares in ASX biotech Starpharma Holdings Ltd (ASX: SPL) have hit a new 12-month high after the company announced positive news regarding one of its drug candidates.
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Novel cancer treatment being tested
The company said in a statement to the ASX on Tuesday that it had met with the US Food & Drug Administration (FDA) in what is called a Type C guidance meeting and had received positive feedback on the proposed clinical development strategy and design of the first-in-human (FIH) phase 1 clinical study for its DEP HER2 radiotherapy candidate.
The company said regarding the drug candidate:
DEP HER2 is a HER2 receptor-targeting dendrimer conjugate with a lutetium-177 radionuclide payload. Starpharma is developing DEP® HER2 for the treatment of locally advanced or metastatic HER2-overexpressing gastric/gastro-oesophageal junction cancers and other HER2 expressing advanced cancers in patients who have received prior HER2-targeted therapy.
The company said over-expression of HER2 is a key driver of aggressive breast and gastric cancers, and there were limited treatment options "after progression, resistance, or toxicity from current HER2-directed therapies''.
The company added:
The FDA confirmed that patients with advanced HER2-expressing cancers who have exhausted available HER2-directed therapies represent a population with significant unmet medical need, meaning that there is potential to pursue Fast Track designation and other accelerated development pathways for DEP HER2 in the future.
Starpharma said it intends to conduct a Phase I study in Europe, initially involving up to 15 patients, to assess safety and tolerability, among other factors.
The company said the FDA had confirmed that clinical data generated outside the US could be used to support future US-based clinical studies under an Investigational New Drug (IND) application
Milestones being met
Starpharma Chief Executive Cheryl Maley said DEP HER2 was a key strategic asset for the company.
She added:
We are particularly excited by the encouraging data generated to date, which have shown important benefits in targeted delivery for radiotherapeutics. "This FDA feedback is an important milestone, providing regulatory clarity and validation for the proposed clinical development pathway and marking the exciting transition from preclinical to clinical development. The guidance provides confidence that our current preclinical package, together with the data generated in the forthcoming first-in-patient study, would support a subsequent IND application and clinical development in the US.
Starpharma shares were 5.8% higher on the news at 72 cents. The shares have traded as low as 8.2 cents over the past year.
Starpharma was valued at $286.2 million at the close of trade on Monday.
