Alliance for mRNA Medicines (AMM) Executive Director Clay Alspach released the following statement after results from a Phase 3 clinical trial showed a personalized mRNA cancer therapy, used in combination with a leading immunotherapy, reduced by 42% the risk of disease recurrence for patients with melanoma compared with the immunotherapy alone:
“These impressive results mark an important milestone for melanoma patients. For the first time, we have positive Phase 3 clinical trial results for an individualized neoantigen therapy using mRNA technology. We’ve moved from the promise of mRNA cancer therapies to tangible results that will help improve people’s lives. And this is just one step in a broader effort to end cancer as we know it.
“mRNA is opening the door to a new kind of cancer treatment that can be tailored to each patient’s unique tumor. To fully realize this potential, we need a modernized regulatory approach that keeps pace with the science. While these therapies are personalized for an individual’s distinct tumor, they can share a common mRNA platform. A modernized pathway that approves validated platforms while maintaining rigorous safety and quality oversight can help these cancer therapies reach patients safely and more quickly.
“We also need continued federal investment in mRNA innovation. Past government support for mRNA research—including during Operation Warp Speed—has helped propel the science forward. As the results from this Phase 3 study clearly show, now is not the time to go backward.”
Alliance for mRNA Medicines (AMM)
The Alliance for mRNA Medicines (AMM) is dedicated to advancing and advocating for an RNA platform approach to medicine, including protein replacements, gene editing and cell engineering strategies, immunotherapies and vaccines to treat cancer, rare disease, autoimmunity and other chronic and infectious illnesses for the benefit of patients, public health, and society.
We advance this mission by shaping policy, accelerating regulatory science, expanding access, and enabling manufacturing — while convening the scientists, innovators, and industry leaders who are turning RNA’s promise into reality. Our goal is simple: ensure that transformative RNA medicines reach every patient who needs them. Learn more at https://mrnamedicines.org
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