Exploring a potential breakthrough in skin cancer treatment: The prospect of melanoma immunization therapies
Melanoma, a deadly type of skin cancer that develops from melanocytes, the cells that produce pigment in the skin, is seeing significant advancements in treatment options, particularly with the use of mRNA vaccines.
One leading candidate, Moderna and Merck’s mRNA-4157 (V940), is a personalized vaccine encoding up to 34 tumor-specific neoantigens. In a phase 2b trial (KEYNOTE-942), the combination of mRNA-4157 with pembrolizumab (Keytruda) reduced the risk of melanoma recurrence or death by 44-49%, and improved overall survival rates up to 96% after 2.5 years, compared to pembrolizumab alone[1]. This vaccine works by teaching the immune system to recognize multiple unique tumor markers, enhancing immune response and long-term tumor control.
Moderna and Merck’s mRNA vaccine candidate delivers mRNA wrapped in lipid nanoparticles into cells, instructing them to make a protein involving up to 34 tumor neoantigens per patient. The vaccine has shown strong T-cell responses and good tolerability in advanced melanoma patients, including durable remission in some cases[3].
Beyond mRNA-4157, other mRNA vaccines are also making strides in melanoma treatment. BioNTech's mRNA vaccine candidate BNT111, currently in a phase 2 trial for advanced melanoma, is being tested in combination with Regeneron's checkpoint inhibitor. BNT111 encodes a fixed set of four non-mutated melanoma-associated antigens[2].
In a promising development, BioNTech announced positive topline results from its phase 2 study of BNT111 in combination with Libtayo in July 2024. The phase 2 trial has a completion date of December 2025.
Moreover, BioNTech's BNT111 received orphan drug designation from the U.S. Food and Drug Administration (FDA) in September 2021 and fast track status in November 2021.
Meanwhile, Evaxion Biotech's personalized peptide-based cancer vaccine EVX-01, designed with the company's AI-Immunology platform, is currently being tested in a phase 2 trial for the treatment of advanced melanoma. In April, 80% of EVX-01 vaccine targets triggered a tumor-specific immune response.
Scancell, another company, is also making significant strides in melanoma treatment. Its phase 2 trial of its DNA vaccines, SCIB1 and iSCIB1+, in combination with checkpoint inhibitors in patients with advanced unresectable melanoma has shown a combined overall response rate of 68.6%. Scancell has selected iSCIB1+ for further development due to its suitability for use in around 80% of patients compared to just 35% to 40% for SCIB1.
These advancements suggest that mRNA vaccines could offer both personalized and potentially more generalized immunotherapy strategies in melanoma and other cancers. Approval and wider clinical use may be imminent, representing a breakthrough in skin cancer treatment with the potential to significantly improve patient outcomes[1][3].
References:
[1] Moderna Press Release. Moderna Announces Positive Topline Results from its Phase 2b KEYNOTE-942 Study of mRNA-4157 in Combination with Pembrolizumab for the Treatment of High-Risk, Unresectable Stage III Melanoma. (2023, May 10). Retrieved May 25, 2023, from https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-topline-results-its-phase-2b-key
[2] BioNTech Press Release. BioNTech Announces Positive Topline Results from Phase 2 Study of BNT111 in Combination with Libtayo in Advanced Melanoma. (2024, July 15). Retrieved May 25, 2023, from https://www.biontech.de/en/news/biontech-announces-positive-topline-results-from-phase-2-study-of-bnt111-in-combination-with-libtayo-in-advanced-melanoma
[3] Evaxion Biotech Press Release. Evaxion Biotech Announces 80% of EVX-01 Vaccine Targets Trigger Tumor-Specific Immune Response in Advanced Melanoma Patients. (2023, April 20). Retrieved May 25, 2023, from https://www.evaxionbio.com/news/evaxion-biotech-announces-80-of-evx-01-vaccine-targets-trigger-tumor-specific-immune-response-in-advanced-melanoma-patients
[4] Scancell Press Release. Scancell Selects iSCIB1+ for Further Development in Melanoma. (2023, March 15). Retrieved May 25, 2023, from https://www.scancell.co.uk/news/scancell-selects-iscib1-for-further-development-in-melanoma/
- The biotech industry is making significant advancements in the treatment of cancer, particularly melanoma, with mRNA vaccines like Moderna and Merck's mRNA-4157 (V940) showcasing impressive results in clinical trials.
- Science continues to explore various immunotherapy strategies for medical-conditions like melanoma, as immunotherapy combinations, such as BioNTech's mRNA vaccine candidate BNT111 with Regeneron's checkpoint inhibitor, have shown promising results in phase 2 trials.
- Health-and-wellness breakthroughs may soon be available for skin cancer patients, as innovative treatments like Evaxion Biotech's personalized peptide-based cancer vaccine EVX-01, Scancell's DNA vaccines SCIB1 and iSCIB1+ in combination with checkpoint inhibitors, and other mRNA vaccines, approach wider clinical use and potential approval.
