CureVac Presents Results of a Phase I/IIa Trial in Non-Small Cell Lung Cancer (NSCLC) with CV9201, an mRNA Based Cancer Vaccine, at the 26th Annual SITC Meeting in Washington
- High immune response rate of 84% in heavily pre-treated NSCLC patients
- First evidence for induction of pre-germinal center B-cells following the immunotherapy
CureVac GmbH, the mRNA vaccine company, yesterday presented the results of a Phase I/IIa trial 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.
CureVac is the global leader in mRNA-based vaccination technologies and develops mRNA-based vaccines as therapeutic vaccines in oncology as well as prophylactic vaccines for infectious diseases. The company has completed Phase I/IIa studies with cancer vaccines based on its RNActive® technology platform for the treatment of prostate cancer and non-small cell lung cancer (NSCLC). In addition, CureVac also independently develops RNActive® prophylactic vaccines against various infectious diseases. The company has also developed RNA-based adjuvants. Results with these CureVac products strongly suggest that they are safe and capable of inducing balanced immune responses including humoral and cellular, Th1 and Th2 and effector and memory responses. For more information, please visit: http://www.curevac.com