FRANKFURT, and NEW YORK, 26 April 2023- NeraCare, a leading developer of laboratory tests for personalized survival prediction of melanoma patients, has announced a strategic partnership with SkylineDx, a biotechnology company that focuses on research and development of molecular diagnostics. The agreement includes an exclusive co-development and licensing agreement for Immunoprint®, a proteomic test used to identify early-stage melanoma patients at high risk of relapse and death.
Melanoma is a severe form of skin cancer that can quickly spread, resulting in the majority of skin cancer-related deaths. While recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy, a large group of early-stage patients still lack access to these life-saving therapies, accounting for most of melanoma deaths. Immunoprint® has the potential to help solve this problem.
The anticipated impact of Immunoprint® was highlighted at the 2023 European Association of Dermato-Oncology Congress. Across multiple, independent prospective and archival validation studies, Immunoprint showed a significant improvement of individualized risk prediction beyond the current melanoma staging system (AJCC8).1
"Immunoprint has the potential to select melanoma patients at high risk of relapse and death, with high precision, and therefore allows a highly personalized adjuvant treatment approach already in early-stage melanoma,” said Dr. Dirk Schadendorf, Director of the West German Comprehensive Cancer Center at University Hospital Essen.
Under the agreement, SkylineDx will lead the commercialization of Immunoprint®, while NeraCare will receive royalty payments.
"We are thrilled to partner with SkylineDx, given their proven track record in successful R&D programs and a highly capable team to bring innovative diagnostic solutions to market," said Daniel von Janowski and Friedrich Ackermann, Co-Founders of NeraCare.
"This partnership marks a significant milestone for SkylineDx as the world continues to move towards personalized care, and away from one-size-fits-all approaches to medicine. The team at NeraCare has made great progress in melanoma risk stratification," commented Jvalini Dwarkasing, CSO of SkylineDx. "Through this collaboration, we anticipate to accelerate the development of precision diagnostics and treatment for patients with this life-threatening disease."
With the news of this announcement, the combined efforts of NeraCare and SkylineDx will focus on setting up a phase III clinical trial that will randomize high-risk early-stage melanoma patients to receive drug treatment. If successful, this clinical trial could potentially provide access to drug treatment for up to 28,0002 early-stage melanoma patients globally every year. This would further add to the already significant breakthroughs in adjuvant melanoma therapy in recent history and provide hope for many patients.
References
1. Gershenwald et al. in: AJCC Cancer Staging Manual. Eighth ed., Springer (2017)
2. Approximate number of IB/IIA melanoma patients identified by Immunoprint at “high risk of relapse and death” in Europe, North America, Australia and New Zealand, based on the currently available validation data