Novel Vaccine Shows Promise in Treating Prostate Cancer

Active immunotherapy is emerging as a potential therapeutic approach for prostate cancer, and new data suggests that a novel vaccine could be a game-changer in the fight against this deadly disease. Researchers in Athens, Greece, have conducted the first phase I trial of an Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine (AE37) with recombinant granulocyte macrophage colony-stimulating factor as adjuvant in patients with HER-2/neu(+) prostate cancer. The trial, published in Clinical Cancer Research, demonstrated that the vaccine is safe and can induce HER-2/neu-specific cellular immune responses in patients with castrate-sensitive and castrate-resistant prostate cancer.

Key Takeaways:

  • The trial enrolled 32 HER-2/neu(+), castrate-sensitive, and castrate-resistant prostate cancer patients, of which 29 completed all six vaccination cycles with AE37.
  • Immunologic responses in the total patient population were monitored by delayed-type hypersensitivity and IFN-gamma ELISPOT and intracellular staining.
  • Regulatory T-cell (Treg) frequency and plasma HER-2/neu and transforming growth factor-beta levels were also determined.
  • Seventy-five percent of patients developed augmented immunity to the AE37 vaccine and 65% to the unmodified AE36 peptide as detected in the IFN-gamma-based ELISPOT assay.
  • Intracellular IFN-gamma analyses revealed that AE37 elicited both CD4(+) and CD8(+) T-cell responses.
  • Eighty percent of the patients developed a positive delayed-type hypersensitivity reaction to AE36.
  • Significant decreases could be detected in circulating Treg frequencies, plasma HER-2/neu, and serum transforming growth factor-beta levels.

Statistics:

  • 75% of patients developed augmented immunity to the AE37 vaccine.
  • 80% of patients developed a positive delayed-type hypersensitivity reaction to AE36.
  • 65% of patients developed immunity to the unmodified AE36 peptide.
  • 32 patients were enrolled in the trial.
  • 29 patients completed all six vaccination cycles with AE37.
  • Significant decreases were detected in circulating Treg frequencies, plasma HER-2/neu, and serum transforming growth factor-beta levels.

Sources:

  • Perez, S.A., et al. "Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer." Clinical Cancer Research, 2010; 16(13): 3495-506.
  • Biotech Week editors, "Novel Vaccine Shows Promise in Treating Prostate Cancer," Biotech Week, 2010.