Aura Biosciences expects to have an active investigational new drug (IND) application for its first-in-class treatment for primary choroidal melanoma early next year and have a first clinical readout sometime later in 2017, founding CEO Elisabet de los Pinos, PhD, reported at the
Posterior Segment Company Showcase at OIS@AAO 2016.
Aura received FDA orphan drug designation last year for AU-011, a viral nanoparticle conjugate (VNC) that targets ocular cancers. After the agent is injected intravitreally, it is activated by a 689-nm ophthalmic laser. The light-activated drug then disrupts the tumor cell membrane. Animal studies have shown AU-011 to be effective in treating primary ocular tumors.
About 10,000 people worldwide have choroidal melanoma and the only treatments currently available are radiation and surgery (enucleation). Patients are diagnosed early in the disease course with small melanocytic lesions or small melanomas that are typically non-metastatic and are just in watchful waiting until further growth or transformation. Unfortunately, about 25% of patients despite being treated with radiation therapies for their primary tumor will progress to metastatic disease in five years, and there is no approved therapy for metastatic ocular melanoma, Dr. de los Pinos noted.
Going forward, Aura expects to begin safety studies of AU-011 for treatment of primary choroidal melanoma mid-year 2017 with an early readout of clinical efficacy, Dr. de los Pinos said. The Phase II/III registration trial is on track for 2018.
Elisabet de los Pinos
Eli founded Aura with a vision to transform cancer treatment by developing a novel class of targeted cancer therapy using viral-like particles (VLPs) to deliver drugs selectively to cancer cells, while leaving surrounding tissue unharmed.