Melanoma — high mutational burden makes it the proving ground for personalized neoantigen vaccines, including the mRNA-4157 + pembrolizumab adjuvant program.
The data stems from a one-year extension of the phase 2 trial evaluating EVX-01 in patients with advanced melanoma (skin cancer). In the third year, patients received EVX-01 as stand-alone therapy, meaning the data will offer insight into the vaccine’s effect also when not admini…
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Primary tumors and their sentinel lymph nodes are functionally linked sites of anti-tumor immunity, yet how T cell receptor (TCR) repertoires are organized across these compartments remains incompletely understood. We thus performed TCR{beta} sequencing on paired primary melanoma…
Dana-Farber Cancer Institute is evaluating NeoVax in melanoma. The Phase I study combines the personalized neoantigen peptide vaccine with CDX-301 and either nivolumab or pembrolizumab.
Dana-Farber Cancer Institute is investigating NeoVax for advanced melanoma. The Phase I study combines the personalized vaccine with ipilimumab and nivolumab, utilizing Montanide as an adjuvant.
Moderna’s KEYNOTE-942 trial is actively assessing the efficacy of mRNA-4157 combined with pembrolizumab as adjuvant therapy for high-risk melanoma. The study compares recurrence-free survival against pembrolizumab alone in participants who have undergone complete resection.
Personalized cancer vaccine reduces risk of recurrence in high-risk melanoma springermedicine.com
[COMPLETED · PHASE1 · Patrick Ott, MD, PhD] This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by us…
[ACTIVE_NOT_RECRUITING · PHASE3 · Merck Sharp & Dohme LLC] The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents…
An immunogenic personal neoantigen vaccine for patients with melanoma Nature
Merck Sharp & Dohme has terminated the Phase 2/3 V940-007 trial evaluating intismeran autogene (V940) plus pembrolizumab in locally resectable advanced cutaneous squamous cell carcinoma. The termination halts the development of this personalized neoantigen therapy in this specific indication, though the parallel Phase 3 melanoma study (NCT05933577) remains active and not yet recruiting.
Fred Hutchinson Cancer Center is recruiting for a phase 1 trial of a personalized neo-antigen peptide vaccine combined with the Th1 polarizing adjuvant poly ICLC. The study targets stage IIIC-IV melanoma, metastatic breast cancer, and stage III-IV NSCLC to induce polyclonal cytolytic T cell immunity.
Moderna and Merck have released five-year follow-up data for their personalized cancer vaccine candidate combined with KEYTRUDA in melanoma, demonstrating durable clinical benefit. This long-term efficacy signal is critical for validating the neoantigen vaccine platform's ability to sustain immune responses and improve survival outcomes in advanced disease.
WCNC reports on a personalized cancer vaccine showing promising long-term results in melanoma patients. While specific data points are not provided in the source, the emphasis on long-term outcomes aligns with industry goals of achieving durable remission through immune memory induction.
WCNC highlights a personalized cancer vaccine demonstrating promising long-term results in melanoma. This reinforces the clinical narrative that neoantigen vaccines may offer sustained benefit beyond initial response, a key differentiator for investors assessing long-term value propositions.
CancerNetwork discusses the potential for personalized cancer vaccines to transform kidney cancer treatment options. This commentary reflects growing industry interest in expanding neoantigen vaccine indications beyond melanoma and lung cancer into other solid tumor types with unmet needs.
Dana-Farber Cancer Institute is conducting a Phase I trial evaluating NeoVax (personalized neoantigen peptides + poly-ICLC) combined with CDX-301 and either Nivolumab or Pembrolizumab for melanoma. The study is currently active but not recruiting, testing the combination of a personalized vaccine platform with checkpoint inhibitors and a novel adjuvant.
A mechanistic and clinical review in Frontiers examines personalized melanoma immunotherapy, focusing on the biological rationale and translational challenges of neoantigen-based vaccines. The review contextualizes current clinical outcomes within the broader landscape of precision immunotherapy, addressing both the promise and limitations of targeting tumor-specific mutations.
Fred Hutchinson Cancer Center has launched a Phase I trial recruiting patients with stage IIIC-IV melanoma, metastatic breast cancer, or stage III-IV NSCLC. The study evaluates a personalized neo-antigen peptide vaccine combined with the Th1-polarizing adjuvant poly ICLC to induce polyclonal cytolytic T cell immunity.
David Braun, MD, discusses a Phase 2 trial of an individualized neoantigen therapy for renal cell carcinoma (RCC). This coverage signals ongoing clinical validation of personalized approaches in urologic malignancies beyond melanoma and lung cancer.
Personalized Cancer Vaccines Show Promise for Select Melanoma Populations CancerNetwork
A personalized cancer vaccine reduced melanoma recurrence by 49%, providing concrete clinical evidence of efficacy in this indication. This result underscores the commercial viability of personalized vaccine platforms in adjuvant settings where preventing recurrence is a key unmet need.
A new study demonstrates that a circRNA neoantigen vaccine (circRNAMNA) encoding melanoma neoantigens suppresses tumor growth and synergizes with checkpoint blockade. Single-cell RNA sequencing reveals that the vaccine reshapes the immune microenvironment by increasing infiltration of antitumor monocytes/macrophages and eliminating specific tumor subclusters.