First in man study: Bcl-Xl_42-CAF®09b vaccines in patients with locally advanced prostate cancer

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  • Sofie Kirial Mørk
  • Per Kongsted
  • Marie Christine Wulff Westergaard
  • Benedetta Albieri
  • Joachim Stoltenborg Granhøj
  • Marco Donia
  • Evelina Martinenaite
  • Morten Orebo Holmström
  • Kasper Madsen
  • Julie Westerlin Kjeldsen
  • Rikke Boedker Holmstroem
  • Cathrine Lund Lorentzen
  • Nis Nørgaard
  • Lars Vibe Andreasen
  • Grith Krøyer Wood
  • Dennis Christensen
  • Michael Schantz Klausen
  • Sine Reker Hadrup
  • Per thor Straten

Background: The B-cell lymphoma-extra-large (Bcl-XL) protein plays an important role in cancer cells’ resistance to apoptosis. Pre-clinical studies have shown that vaccination with Bcl-XL-derived peptides can induce tumor-specific T cell responses that may lead to the elimination of cancer cells. Furthermore, pre-clinical studies of the novel adjuvant CAF®09b have shown that intraperitoneal (IP) injections of this adjuvant can improve the activation of the immune system. In this study, patients with hormone-sensitive prostate cancer (PC) received a vaccine consisting of Bcl-XL-peptide with CAF®09b as an adjuvant. The primary aim was to evaluate the tolerability and safety of IP and intramuscular (IM) administration, determine the optimal route of administration, and characterize vaccine immunogenicity. Patients and methods: Twenty patients were included. A total of six vaccinations were scheduled: in Group A (IM to IP injections), ten patients received three vaccines IM biweekly; after a three-week pause, patients then received three vaccines IP biweekly. In Group B (IP to IM injections), ten patients received IP vaccines first, followed by IM under a similar vaccination schedule. Safety was assessed by logging and evaluating adverse events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0). Vaccines-induced immune responses were analyzed by Enzyme-Linked Immunospot and flow cytometry. Results: No serious AEs were reported. Although an increase in T cell response against the Bcl-XL-peptide was found in all patients, a larger proportion of patients in group B demonstrated earlier and stronger immune responses to the vaccine compared to patients in group A. Further, we demonstrated vaccine-induced immunity towards patient-specific CD4, and CD8 T cell epitopes embedded in Bcl-XL-peptide and an increase in CD4 and CD8 T cell activation markers CD107a and CD137 following vaccination. At a median follow-up of 21 months, no patients had experienced clinically significant disease progression. Conclusion: The Bcl-XL-peptide-CAF®09b vaccination was feasible and safe in patients with l hormone-sensitive PC. In addition, the vaccine was immunogenic and able to elicit CD4 and CD8 T cell responses with initial IP administration eliciting early and high levels of vaccine-specific responses in a higher number og patients. Clinical trial registration:, identifier NCT03412786.

Original languageEnglish
Article number1122977
JournalFrontiers in Immunology
Publication statusPublished - 2023

Bibliographical note

Publisher Copyright:
Copyright © 2023 Mørk, Kongsted, Westergaard, Albieri, Granhøj, Donia, Martinenaite, Holmström, Madsen, Kverneland, Kjeldsen, Holmstroem, Lorentzen, Nørgaard, Andreasen, Wood, Christensen, Klausen, Hadrup, thor Straten, Andersen and Svane.

    Research areas

  • cancer vaccine, immune response, immunotherapy, peptide, prostate cancer

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