Journal article
Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma
Copenhagen University Hospital Herlev and Gentofte1
T-Cells and Cancer, Experimental & Translational Immunology, Department of Health Technology, Technical University of Denmark2
Experimental & Translational Immunology, Department of Health Technology, Technical University of Denmark3
Department of Health Technology, Technical University of Denmark4
Evaxion Biotech A/S5
Statens Serum Institut6
Rigshospitalet7
The majority of neoantigens arise from unique mutations that are not shared between individual patients, making neoantigen-directed immunotherapy a fully personalized treatment approach. Novel technical advances in next-generation sequencing of tumor samples and artificial intelligence (AI) allow fast and systematic prediction of tumor neoantigens.
This study investigates feasibility, safety, immunity, and anti-tumor potential of the personalized peptide-based neoantigen vaccine, EVX-01, including the novel CD8+ T-cell inducing adjuvant, CAF®09b, in patients with metastatic melanoma (NTC03715985). The AI platform PIONEERTM was used for identification of tumor-derived neoantigens to be included in a peptide-based personalized therapeutic cancer vaccine.
EVX-01 immunotherapy consisted of 6 administrations with 5–10 PIONEERTM-predicted neoantigens as synthetic peptides combined with the novel liposome-based Cationic Adjuvant Formulation 09b (CAF®09b) to strengthen T-cell responses. EVX-01 was combined with immune checkpoint inhibitors to augment the activity of EVX-01-induced immune responses.
The primary endpoint was safety, exploratory endpoints included feasibility, immunologic and objective responses. This interim analysis reports the results from the first dose-level cohort of five patients. We documented a short vaccine manufacturing time of 48–55 days which enabled the initiation of EVX-01 treatment within 60 days from baseline biopsy.
No severe adverse events were observed. EVX-01 elicited long-lasting EVX-01-specific T-cell responses in all patients. Competitive manufacturing time was demonstrated. EVX-01 was shown to be safe and able to elicit immune responses targeting tumor neoantigens with encouraging early indications of a clinical and meaningful antitumor efficacy, warranting further study.
Language: | English |
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Publisher: | Taylor & Francis |
Year: | 2022 |
Pages: | 2023255 |
ISSN: | 2162402x and 21624011 |
Types: | Journal article |
DOI: | 10.1080/2162402X.2021.2023255 |
ORCIDs: | 0000-0003-4966-9752 , 0000-0002-9451-6037 , Kadivar, Mohammad , Skadborg, Signe Koggersbøl , Overgaard, Nana and Hadrup, Sine Reker |
Cancer vaccine Immune response Immunotherapy Neoantigen Personalized therapy SDG 3 - Good Health and Well-being
ANTI-PD-1 AVIDITY Antigens, Neoplasm Artificial Intelligence BLOCKADE CAF09 CANCER Cancer Vaccines FUTURE Humans IMMUNITY Immunologic diseases. Allergy Melanoma Neoplasms. Tumors. Oncology. Including cancer and carcinogens Peptides RC254-282 RC581-607 T-CELL RESPONSES cancer vaccine immune response immunotherapy neoantigen personalized therapy