On November 7, 2011 CureVac GmbH, the mRNA vaccine company, reported the presentation the results of a Phase I/IIa trial (NCT00923312) in non-small cell lung cancer (NSCLC) with CV9201, an mRNA-based cancer vaccine, in patients with NSCLC stage IIIB/IV after first-line chemo-radiotherapy or chemotherapy, respectively. The trial strived to assess safety and toxicity of CV9201 as well as its ability to induce antigen-specific humoral and cellular immune responses in cancer patients. The results suggest that CV9201 is safe, well tolerated and biologically active. The trial evaluated a five dose regime of CV9201 delivered via intradermal injection in 46 patients.
The trial with CV9201, conducted in Germany and Switzerland, was the first to test an immunotherapy based on CureVac´s RNActive vaccination technology in patients after heavy pre-treatment with chemotherapy. 65% of the phase IIa study patients responded to at least one antigen out of the five antigens in CV9201. "Importantly, CureVac‘s therapeutic mRNA vaccine CV9201 induces responses against multiple antigens in two thirds of immunologically responding patients. Moreover, we see profound B-cell activation in 61% of the patients. This makes an overall antigen-specific or B-cell response of 84%. We also see immune responses against all included antigens. All in all, these data are extremely encouraging and confirm our previous results in prostate cancer," said Dr. Kajo Kallen, CSO and CMO of CureVac.
The results of the NSCLC trial underpin the broad applicability of CureVac’s proprietary RNActive vaccination technology to generate novel cancer vaccines against tumor-associated antigens. The results are seen as another important validation step of CureVac’s innovative proprietary RNActive vaccination technology.
Dr. Ingmar Hoerr, CEO of CureVac, said "I believe these new results are excellent news for patients. We are eager to further investigate our RNActive vaccination technology in oncology. In fact, CureVac´s RNActive vaccination technology could represent a real step forward in the effort to develop disease specific or even patient specific cancer immunotherapies."
CureVac´s RNActive tumor immunotherapy approach is independent of the HLA subtype. CV9201 is one candidate in CureVac’s pipeline of RNActive-derived molecules for the active immunotherapy of cancer. The vaccine comprises mRNA molecules encoding five different antigens of which three are cancer testis antigens.

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