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Product › Details

RNActive® vaccination technology

Products Next higher product group RNAi technology_o
Period Status 2006-01-18 development existent
Organisation Organisation CureVac GmbH
  Today CureVac AG

CureVac GmbH. (10/4/10). "Press Release: CureVac Presents Convincing Data from the First Ever Phase I/IIa Clinical Study with a mRNA Based Vaccine. Strong Results in Safety, Tolerability and Biological Activity – First Important Validation of CureVac’s R

CureVac GmbH, the mRNA vaccine company, announced today first data from an open-label phase I/IIa clinical trial of its mRNA vaccine CV9103 in patients with hormone-refractory prostate cancer with rising PSA and existing metastasis in the vast majority of patients. The trial was designed to assess safety and toxicity of CV9103 as well as its ability to induce antigen specific humoral and cellular immune responses in cancer patients. The results suggest that CV9103 is safe, well tolerated and biologically active. Over 70% of the study patients responded to at least one antigen out of the four antigens in CV9103. The trial evaluated a five dose regime of CV9103 delivered via intradermal injection in 44 patients.

The trial with CV9103, conducted in Germany and Italy, was the first to test a immunotherapy based on CureVac´s RNActive® vaccination technology in humans. "CureVac's therapeutic mRNA vaccine induces responses against multiple antigens in 65% of immunologically responding patients when analyzing the data with strict criteria. In addition, we see a response against all included antigens. These data are extremely encouraging," said Dr. Kajo Kallen, CSO of CureVac. "The results are seen as a first important validation of CureVac's innovative proprietary RNActive® vaccination technology in humans."

The data generated from this first clinical application of CureVac´s RNActive® vaccination technology provide the first clear evidence that CV9103 could represent a real step forward in the application of a new approach to the treatment of prostate cancer. This disease represents an area where there is an enormous unmet clinical need and this early success provides an active stimulus to expedite the development of this new technology.

Dr. Ingmar Hoerr, CEO of CureVac, said "These first results are excellent news for CureVac. We are highly motivated to further demonstrate the value of our RNActive® vaccination technology in oncology and infectious diseases."

CureVac´s RNActive® tumor immunotherapy approach is independent of the HLA subtype. The vaccine comprises mRNA molecules encoding four different antigens of which three are membrane bound. CV9103 is one candidate in CureVac's pipeline of RNActive®-derived molecules for the active immunotherapy of cancer.

Record changed: 2018-02-01


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