Recently, clinical-stage biopharmaceutical company Aura Biosciences announced a Phase 2 clinical trial to determine the safety, efficacy, and tolerability of AU-011 for patients with choroidal melanoma. Currently, Aura Biosciences is developing targeted anti-tumor therapies designed to fit the needs of patients with primary tumors. In this case, AU-011 is delivered suprachoroidally, or directly into the ocular space between the sclera and choroid. Now, the first patient has been both enrolled and dosed in the study.
In this study, researchers will determine whether AU-011 will be an effective first-line therapy for patients with choroidal melanoma. Because of its administration in the suprachoroidal space, it offers more targeted treatment than intravitreal injections. The trial consisted of an initial cohort which noted AU-011 as both effective and safe. Now, researchers hope to understand the ideal dosage, as well as continue to build data on safety and efficacy.
During the trial, participants will receive AU-011 (belzupacap sarotalocan). By administering it suprachoroidally, researchers believe there will be higher bioavailability. AU-011 uses Aura’s proprietary viral-like particle bioconjugates (VPB) that are activated via laser. These VPBs bind to cancerous cell receptors. When activated by the laser, the VPBs destroy tumor cells while still protecting healthy ocular cells. Because no surgery is required, AU-011 offers a less invasive and more accessible treatment for many. As of today, the FDA granted Orphan Drug and Fast Track designations to AU-011.
To first understand this condition, you need to know what melanoma is. Melanoma is a severe form of skin cancer that can develop anywhere on your body. Often, melanoma occurs in areas of high sun exposure: arms, legs, head, neck. The cancer is caused by cancer cells developing in melanocytes. Thus, choroidal melanoma is melanoma formed in a part of your eye called the choroid. According to Harvard Medical School, the choroid is:
the sponge-like membrane at the back of the eye between the sclera (the white of the eye) and the retina. The choroid is rich in blood vessels and supplies nutrients to the retina.
Choroidal melanoma is rare and aggressive. Yet no targeted therapies exist. As the cancer progresses, the tumors grow, causing detached retinas and vision loss. Without treatment (radiation, surgery, chemotherapy), it can spread to other parts of the body, such as the liver. In fact, around 50% of all cases will progress and metastasize, with the liver becoming damaged in up to 90% of those patients.
Many patients will experience no symptoms. However, if symptoms occur, these include:
- Flashing lights
- Severe and persistent eye pain
- Blurred vision
Learn more about choroidal melanoma here.