eTheRNA plans to run phase Ib clinical studies with an in vivo, injectable TriMix mRNA product in melanoma patients.
Malignant melanoma is a type of skin cancer that can develop from abnormal moles. It is an invasive and aggressive neoplasm of the melanocytes, the melanin-producing cells. Cancer of the skin is by far the most common of all cancers. Melanoma accounts for only 1% of skin cancer cases but causes a large majority of skin cancer deaths.
The American Cancer Society estimates that in 2016 about 76 380 new melanomas will be diagnosed in the US (about 46 870 in men and 29 510 in women) and that about 10 130 people in the US are expected to die of melanoma (about 6 750 men and 3 380 women). The rates of melanoma have been rising for at least 30 years. Overall, the lifetime risk of getting melanoma is about 2.4% (1 in 40) for whites, 0.1% (1 in 1 000) for blacks, and 0.5% (1 in 200) for Hispanics. The risk for each person can be affected by a number of different factors such as family history, fair skin, history of sunburn, having many moles... The risk of melanoma increases as people age. The average age at the time it is found is 62. But melanoma is not uncommon even among those younger than 30. In fact, it is one of the most common cancers in young adults (especially young women).
Surgery is generally the first option for treatment for early-stage melanoma. If melanoma is diagnosed early, the survival statistics are very good. Most stage 1 and stage 2 melanomas can be cured. 80% of stage 2 patients (spread to the lower part of the skin, but not yet into the tissue below the dermis) will survive for 5 years or more after diagnosis.
For the more advanced stages (stages 3 and 4), understandably, the survival statistics are lower than for earlier stages. Stage 3 (when the melanoma has spread to the lymph nodes). 50 out of 100 men diagnosed with stage 3 melanoma (50%) will survive for 5 years or more after they are diagnosed. Stage 4 (when the melanomas have spread elsewhere in the body: lung, liver or brain or to distant lymph nodes or areas of the skin). Almost 10 out of 100 of men with stage 4 melanoma (10%) will survive for 5 years or more after they are diagnosed.
During the last decade, a number of new therapies have been developed for metastatic melanoma. The current treatment options include: chemotherapy, biological therapy (including immunotherapy), radiotherapy and surgery, or combinations of the aforementioned options. New therapies targeting the immune-checkpoints have brought hope for melanoma patients: treatment with checkpoint inhibitors will result in sustainable responses in some patients.
If successful, the off-the-shelf injectable TriMix-product may help each year hundreds of thousands of patients throughout the world. However, the development of this product may still require various years, and the outcome of the clinical studies remains unsure, as for any new treatment under development.