Date: 2015-07-11
Type of information: Publication of results in a medical journal
phase: 1-2
Announcement: publication of results in The Journal for ImmunoTherapy of Cancer
Company: Curevac (Germany)
Product: RNActive® vaccine CV9103
Action
mechanism: . CV9103 is a self-adjuvanted, sequence-optimized, chemically unmodified mRNA immunotherapy targeting four antigens: prostate-specific antigen (PSA), prostate-specific membrane antigen (PSMA), prostate stem cell antigen (PSCA), and sixtransmembrane epithelial antigen of the prostate 1 (STEAP1).
Disease: advanced castration-resistant prostate cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: CureVac GmbH has presented at the ASCO Conference in Chicago final results of the world‘s first phase I/IIa clinical trial using RNActive® vaccine CV9103 to treat patients with advanced castration-resistant prostate cancer. These final trial results confirm the preliminary data published previously and demonstrate the safety and excellent antigen-specific immunogenicity of prostate cancer vaccine CV9103.
CV9103 induced an antigen-specifi c immune response in 79% of the evaluable patients per protocol to at least one antigen, with more than half of these patients developing specific immune responses to more than one antigen. Furthermore, immune responses against all four antigens in the vaccine were detected.
Latest
news: * On July 7, 2015, CureVac announced that a Phase I/IIa study of the company’s mRNA cancer immunotherapy (CV9103) in advanced castration-resistant prostate cancer was published in the peer-reviewed Journal for ImmunoTherapy of Cancer. The research article, titled “Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study,” describes CureVac’s clinical study of CV9103 in 44 patients with advanced castration-resistant prostate cancer. The related data signify the first Phase IIa clinical study in which an mRNA therapy has demonstrated antigenspecific immune responses in the majority of patients. Based on the favorable data, CureVac is currently conducting a randomized, placebo-controlled Phase IIb study in 197 prostate cancer patients with the follower vaccine CV9104 targeting six antigens.
As described in the article, the Phase I part of the study was designed to investigate the safety and recommended dosage of CV9103, with 12 patients up to five intradermal injections of 256 (n = 3), 640 (n = 3), or 1280 μg (n = 6) mRNA. In the Phase IIa part, 32 patients were enrolled to receive the recommended dose of 1280 μg mRNA defined in Phase I. The primary endpoint of the study was safety and tolerability, and the secondary endpoint was induction of antigen specific immune responses monitored at baseline and at weeks 5, 9 and 17.
Data indicated that CV9103 was well tolerated, with the majority of related adverse events being of mild to moderate intensity. The most frequent treatment-related side effects were injection site erythema and injection site reaction in 27 (61%) and 21 (48%) patients, respectively. A quantitative analysis of ELISpot, ICS, and tetramer staining assays revealed that CV9103 was able to induce both CD4 and CD8 T cell responses. Of the 33 evaluable patients treated at 1280 μg, a cellular immune response could be detected in 25 (76%). Importantly immune responses against all four antigens could be induced indicating the versatility of the platform.
