US-based biotechnology firm Aura Biosciences has begun enrolling and dosing patients in its Phase Ib clinical trial of light-activated AU-011 for the treatment of primary ocular melanoma.
AU-011 is an investigational, targeted therapy consisting of viral nanoparticle conjugates that selectively bind to cancer cells in the eye.
It is derived from the technology introduced by Dr John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI).
The Phase Ib trial will assess the safety of two dose levels of AU-011 in a total of 12 subjects with small-to-medium primary ocular melanoma.
Aura founder and chief executive officer Elisabet de los Pinos said: “We look forward to evaluating and advancing AU-011 alongside Dr Shields and other renowned researchers at ocular oncology centres of excellence in the US.
“Moreover, we will continue to work closely with the FDA under AU-011’s fast-track designation to shape our clinical programme with their input.
"Ultimately, our goal is to equip the physicians who diagnose ocular melanoma early with a new targeted therapy that both prevents tumour growth and leaves other key ocular structures unaffected, thereby preserving vision for patients.”
The trial will include patients with a confirmed diagnosis of ocular melanoma that is not previously treated and a patient follow-up will be conducted throughout the observation period of two years.
The US Food and Drug Administration (FDA) has granted orphan drug and fast-track designations to AU-011 for treating primary ocular melanoma.