Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. The metabolic enzyme arginase-2 is a potential target for novel immune modulatory vaccines

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Staphylococcus aureus alpha-toxin inhibits CD8+ T cell-mediated killing of cancer cells in cutaneous T-cell lymphoma

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Real-world data on melanoma brain metastases and survival outcome

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. B Cells and Tertiary Lymphoid Structures: Friends or Foes in Cancer Immunotherapy?

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  3. Highly efficient PD-1-targeted CRISPR-Cas9 for tumor-infiltrating lymphocyte-based adoptive T cell therapy

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Transcriptomic signatures of tumors undergoing T cell attack

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

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.

OriginalsprogEngelsk
Artikelnummer2023255
TidsskriftOncoImmunology
Vol/bind11
Udgave nummer1
Sider (fra-til)2023255
ISSN2162-4011
DOI
StatusUdgivet - 31 dec. 2022

Bibliografisk note

© 2022 The Author(s). Published with license by Taylor & Francis Group, LLC.

ID: 72635121