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PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Recruiting
18 years and older
Male
Phase 1/2
  • W_pro1 consists of messenger ribonucleic acid (mRNA [or RNA]) targeting 5 antigens expressed in de novo and metastatic prostate cancer that are separately complexed with liposomes to form serum-stable RNA lipoplexes (RNA-LPX).
    • The RNA molecules are immune-pharmacologically optimized for high stability, translational efficiency and presentation on major histocompatibility complex (MHC) class I and II molecules. The vaccine is intended for intravenous (IV) bolus injection.
    • The RNA-LPX cancer vaccine induces activation of both the adaptive immune system (vaccine antigen-specific CD8+/CD4+ T cell) as well as the innate immune system (TLR7 agonism of single-stranded RNA). The physiology of efficient induction, expansion and differentiation of antigen-specific T cells is associated with programmed death receptor-1 (PD-1) upregulation on these T cells. Thus, the cancer vaccine is expected to have a synergistic mechanism of action with anti-PD-1.
    • In summary, the mechanism of action of W_pro1 both in monotherapy and in combination with anti-PD-1 immune checkpoint inhibitor cemiplimab, together with carefully selected and refined clinical setting presents a unique opportunity for patients with different stages of prostate cancer.
Study details
    Malignant neoplasm of prostate
    Prostatic disorder

NCT04382898

BioNTech RNA Pharmaceuticals GmbH

19 February 2024

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