Biopharmaceutical firm Bavarian Nordic has begun the new Phase II clinical study of its active prostate cancer immunotherapy candidate, Prostvac.
Prostvac is a ready-to-use immuno-oncology agent, which stimulates an immune response that attacks prostate cancer cells.
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The National Cancer Institute (NCI) has sponsored the study under the collaborative research and development agreement (CRADA) and clinical supply agreement.
Bavarian Nordic president and CEO Paul Chaplin said: "This is a wonderful opportunity to explore the potential benefits of using an active immunotherapy on patients in the early disease setting.
"It is widely believed that using immunotherapy with patients who have a lower disease burden might benefit even more than the efficacy we have already seen in the later stage settings of prostate cancer, thus providing a larger commercial potential for the product candidate."
The company has designed the study as a randomised, double-blind and placebo-controlled trial for men who have localised prostate cancer and are undergoing active surveillance.
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By GlobalDataBavarian Nordic will enrol approximately 90 patients across six sites in the trial and it has the chance to include up to 150 patients in the study.
According to the firm, the primary endpoint of the study is to determine how well Prostvac works in eliciting an immune response in patients with prostate cancer that is found only in the prostate and has not yet metastasized.
The secondary endpoints of the trial will comprise effects of Prostvac on changes in PD-L1 expression, PSA doubling time, and change in tumour grade (Gleason score).
Currently, Prostvac is being assessed in a global, randomised, double-blind, and placebo-controlled phase III Prospect study, which has fully enrolled at 1,298 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Image: Micrograph showing prostatic acinar adenocarcinoma (the most common form of prostate cancer). Photo: courtesy of Nephron.
