On February 16, 2022, biotechnology company Hillstream BioPharma Inc. (“Hillstream”) shared that its drug candidate HSB-1216 received Orphan Drug designation from the U.S. Food and Drug Administration. This particular designation was granted for uveal melanoma, although HSB-1216 has also received Orphan Drug designation for small cell lung cancer (SCLC).
So what exactly is HSB-1216? Developed by Hillstream, HSB-1216 is:
A novel and potent inducer of a powerful mechanism involving iron-mediated cell death. This process which sequesters iron in lysosomes allows HSB-1216 to cause lysosomal membrane permeation of hard-to-treat cancer cells – causing them to rupture and stop replicating.
Now, HSB-1216 has received Orphan Drug designation for uveal melanoma. Orphan Drug designation is granted to drugs or biologics intending to treat, diagnose, or prevent rare diseases or conditions. For this purpose, “rare” is defined as a condition affecting under 200,000 Americans. As a benefit, Hillstream also earns fee waivers, tax credits, increased regulatory assistance, and 7 years market exclusivity following approval.
In the future, the company hopes to file an Investigational New Drug (IND) application, as well as launch at least one clinical trial to evaluate HSB-1216 for patients with solid tumors.
Uveal melanoma may also be referred to as ocular melanoma, or melanoma that forms in the iris, choroid layer, or ciliary body (uvea) within the eye. Despite the fact that uveal melanoma is rare, it is also considered the most common primary intraocular cancer. In rare cases, uveal melanoma may affect the eye socket; however, it more typically occurs in the three parts listed above. Risk factors associated with this cancer include being Caucasian, being older in age, UV light exposure, and having light eyes. Associated symptoms include:
- Growing dark spots on the iris
- Pupil shape changes
- Blurred vision
- Vision loss
- “Floaters” or flashes of light
- A change of position of the eyeball within the eye socket
- Glaucoma (complication)
Learn more about ocular melanoma.