There are several experimental treatments undergoing study for types of melanoma. BioSpace rounds up some of the most recent clinical news in this space.
The weather is warming up and, after months of pandemic-related isolation, many people are planning to venture out and enjoy a plethora of outdoor activities. According to CDC guidelines, COVID-19 is less of a worry in outdoor settings, but people should be aware of another concern – skin cancer.
Skin cancer is the most common form of cancer in the United States. According to the U.S. Centers for Disease Control and Prevention, too much sun can increase your risk of getting skin cancer. There are multiple kinds of skin cancers, from the common basal cell carcinomas and squamous cell carcinomas to the more severe and sometimes fatal melanomas.
There are several experimental treatments undergoing study for types of melanoma. BioSpace rounds up some of the most recent clinical news in this space.
Alkermes
Ireland-based Alkermes plc launched the Phase II ARTISTRY-6 study assessing the anti-tumor activity, safety, and tolerability of nemvaleukin alfa (nemvaleukin) monotherapy in patients diagnosed with melanoma who have been previously treated with anti-PD-(L)1 therapy.
The study will evaluate an intravenously administered form of nemvaleukin in patients with mucosal melanoma and a subcutaneous form in patients with advanced cutaneous melanoma. The study also includes a cohort of patients with advanced cutaneous melanoma who will receive subcutaneous nemvaleukin with the intent to establish a monotherapy proof-of-concept with this type of dosing.
Alkermes’ lead immuno-oncology candidate nemvaleukin, which aims at two different kinds of melanoma, is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy.
In March, the U.S. Food and Drug Administration granted nemvaleukin Orphan Drug Designation to treat mucosal melanoma, a rare and aggressive form of melanoma with limited treatment options.
Pending the outcome of the ARTISTRY-6 study, Alkermes Chief Medical Officer Craig Hopkinson said the company is discussing a potential filing pathway for nemvaleukin in mucosal melanoma based on data from the Phase II trial.
Instil Bio
Texas-based Instil Bio’s melanoma treatment also received Orphan Drug Designation from the FDA. This morning, the company said its ITIL-168 TIL therapy received the designation for the treatment of melanoma stages IIB to IV. ITIL-168 is an investigational, autologous cell therapy made from tumor-infiltrating lymphocytes or TILs. Instil plans to investigate ITIL-168 in a global Phase II study in advanced melanoma this year and assess the asset against additional solid tumor indications in Phase I clinical trials planned for 2022.
Myriad Genetics
Utah-based Myriad Genetics, Inc. announced it would sell its melanoma diagnostic testing laboratory to Castle Biosciences for $32.5 million. The Myriad myPath Melanoma, LLC, Laboratory offers the myPath Melanoma test, which has been used to guide treatment in nearly 40,000 melanoma patients. Myriad said the trial had been used by approximately 20% of dermatopathologists in the country.
Myriad Chief Executive Officer Paul J. Diaz said the divestiture of the myPath Melanoma lab would allow the company to focus on its core businesses in Women’s Health, Oncology, and Mental Health. Also, he said the sale would provide growth capital for future investment.
Cannabics Pharmaceuticals
Israel-based Cannabics Pharmaceuticals is on the hunt for a melanoma antitumor targeting medicine. The company announced the beginning of a new program following a series of preclinical experiments within the company’s in-house research facilities demonstrating promising antitumor results on melanoma cell lines.
The new program comes on the heels of Cannabics’ successful in-vivo work with colorectal cancer. That work demonstrated a 33% reduction in tumor volume and a 35% increase in survival rate in animal experiments.
“Following our decision to develop an additional antitumor drug candidate to target Melanoma, we were able to produce high quality preclinical data, as well as identify several promising findings that we now plan to further investigate. This method of evaluation organically points towards the path of developing a new drug candidate for the treatment of melanoma,” Gabriel Yariv, president and chief operating officer of Cannabics, said in a statement.
Tel Aviv University
Researchers at Tel Aviv University are developing an optical technology that will rapidly diagnose lesions for signs of melanoma. Trials have been successfully carried out on about 100 patients with suspicious lesions in a major hospital in Israel.
The optical technology is non-invasive and has the capability for the early detection of melanoma. By detecting the lesions when they are less than one millimeter thick, it increases chances for recovery. Later diagnoses can be more complicated.
