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    DRUG:

    EVX-01

    i
    Other names: NPV-ds001-CAF09b, EVX-01, EVX 01, EVAX-01-CAF09b, EVX-01 NeoPepVac
    Company:
    Evaxion
    Drug class:
    Immunostimulant
    Related drugs:
    6ms
    Dose escalation study of a personalized peptide-based neoantigen vaccine (EVX-01) in patients with metastatic melanoma. (PubMed, J Immunother Cancer)
    Immunization with EVX-01-CAF09b in addition to anti-PD-1 therapy was shown to be safe and well tolerated and elicit vaccine neoantigen-specific CD4+and CD8+ T cell responses at all dose levels. In addition, objective tumor responses were observed in 67% of patients. The results encourage further assessment of the antitumor efficacy of EVX-01 in combination with anti-PD-1 therapy.
    Journal • Metastases
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • EVX-01
    almost2years
    KEYNOTE KN-D36: A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=90, Recruiting, Evaxion Biotech A/S | Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Aug 2022
    Enrollment open • Trial initiation date • Combination therapy • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BRAF V600E • BRAF V600
    |
    Keytruda (pembrolizumab) • EVX-01
    over2years
    Evaxion to Utilize Personalis’ ImmunoID NeXT Platform to Evaluate Efficacy of Combination Therapy for Late-Stage Melanoma (Personalis Press Release)
    "Evaxion Biotech A/S...and Personalis....announced today that Evaxion will deploy Personalis’ ImmunoID NeXT Platform in a Phase 2b trial to evaluate the efficacy and safety of Evaxion’s personalized cancer immunotherapy EVX-01. The study will combine EVX-01, a neoepitope-targeting immunotherapy based on Evaxion’s proprietary PIONEER® AI technology, with KEYTRUDA® (pembrolizumab) for the treatment of patients with metastatic melanoma."
    Trial status • Licensing / partnership
    |
    EVX-01
    over2years
    KEYNOTE KN-D36: Study of EVX-01 Vaccine in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Evaxion Biotech A/S
    New P2 trial • Combination therapy • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BRAF V600E • BRAF V600
    |
    Keytruda (pembrolizumab) • EVX-01
    almost3years
    Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma. (PubMed, Oncoimmunology)
    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.
    Clinical • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    EVX-01