PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

  • End date
    Jul 14, 2023
  • participants needed
  • sponsor
    BioNTech SE
Updated on 14 July 2021
serum testosterone
luteinizing hormone
adenocarcinoma of prostate
cancer vaccine


Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of W_pro1 cancer vaccine (W_pro1) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC: Part 1 and Part 2 Arms 1A and 1B) and in patients with high-risk, localized prostate cancer (LPC).


  • 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.

Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment goserelin acetate, Cemiplimab, W_pro1
Clinical Study IdentifierNCT04382898
SponsorBioNTech SE
Last Modified on14 July 2021


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