From Science to Patients – Ideas Become Treatments at CureVac

CureVac already has several active ingredients in research and (pre-)clinical development for the treatment of cancer and for protection against infectious diseases. Until today, CureVac has tested its mRNA-based products in eight clinical studies with about 450 human patients and healthy volunteers and has received clinical trial approvals in 10 European countries, Asia and the US.

Our success is tangible, inspiring us to continue on our path every day.

CureVac's Pipeline

RNActive® Cancer Immunotherapy
Research
Pre-clinic
Phase I
Phase II
Phase III
Partner
Prostate Cancer (CV9104)
Phase II

CV9104 is an investigational therapeutic vaccine for patients with prostate cancer. The vaccine is injected into the skin and is designed to stimulate the body's immune system to destroy prostate cancer cells. CV9104 has not been granted marketing authorization in any country to date and no final statements with regards to safety or efficacy of the vaccine can be made.

Current Status: Phase II

Phase I/IIa Trial
CV9104’s predecessor drug, the RNActive® vaccine CV9103, was initially investigated in a phase I/IIa trial in 44 patients with castration refractory prostate cancer. Results from this first clinical trial of CV9103 suggested that the vaccine is well tolerated with transient, mild to moderate injection site reactions and flu-like symptoms as the predominant related adverse events. Immune responses against all four antigens could be induced indicating the versatility of the platform. The follow-up vaccine CV9104 including two additional antigens is currently being tested in a randomized phase IIb trial to assess the clinical benefit induced by this new vaccination approach.

The press release on the publication of the study data can be found here.

The scientific publication of the study data can be found here.

Phase IIb Trial
This study enrolled about 200 patients with asymptomatic or minimally symptomatic metastatic prostate cancer which is castrate resistant. Patients were randomized to receive either CV9104 or placebo in a double-blinded fashion. The lead-in part of the trial had the primary objective to assess the safety of CV9104. The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo. Further objectives include investigation of progression-free survival, quality of life and safety. The study is ongoing.

For further information on this study please visit clinicaltrials.gov.

The press release announcing the start of this phase IIb study in March 2013 can be found here.

First topline results of the study can be found in this press release.

Further results are presently being analyzed, including latest preclinical results on the product candidate in combination with checkpoint inhibitors.

Prostate Cancer (CV9104 presurgical study)
Phase II

CV9104 is an investigational therapeutic vaccine for patients with prostate cancer. The vaccine is injected into the skin and is designed to stimulate the body's immune system to destroy prostate cancer cells. The vaccine targets six tumor-associated antigens, namely PSA, PAP, PSMA, PSCA, Steap1 and MUC1. CV9104 has not been granted marketing authorization in any country to date and no final statements with regards to safety or efficacy of the vaccine can be made.

Current Status: Phase II

Phase I/IIa Trial
CV9104’s predecessor drug, the RNActive® vaccine CV9103, was initially investigated in a phase I/IIa trial in 44 patients with castration refractory prostate cancer. Results from this first clinical trial of CV9103 suggested that the vaccine is well tolerated with transient, mild to moderate injection site reactions and flu-like symptoms as the predominant related adverse events. Immune responses against all four antigens targeted in this version of the vaccine could be induced indicating the versatility of the platform. The follow-up vaccine CV9104 including additional antigens is currently being tested in a randomized phase I/IIb trial to further explore the clinical benefit associated with this novel vaccination approach, and in a phase II trial in patients with localized prostate cancer to investigate immune response and mechanistic effects on the tumor.

Phase II trial
More than 40 Prostate cancer patients with localized prostate cancer with an indication for radical prostatectomy and with high and intermediate risk for disease recurrence were enrolled in this open label randomized trial. The objectives of this trial are to evaluate the induction of immune responses against CV9104 and to assess the safety and tolerability of CV9104. To further elucidate the mechanism of action of CV9104, immune cell infiltration and gene expression profiles will be assessed in tumor tissue.

For further information on this study please visit clinicaltrials.gov.

NSCLC (Combination BI 1361849 / CV9202 with radiation)
Phase I

CV9202 is an investigational therapeutic vaccine for patients with non-small cell lung cancer. CV9202 targets six tumor-associated antigens, namely 5T4, Mage C1, Mage C2, NY-ESO-1, Survivin and MUC1. The vaccine is injected into the skin and is designed to stimulate the body's own immune system to destroy lung cancer cells. CV9202 has been licensed to Boehringer Ingelheim and will be investigated in further clinical trials under the product code BI1361849. BI1361849/CV9202 has not been granted marketing authorization in any country to date and no definitive statements with regards to safety or efficacy of the vaccine can be made.

Sponsor and Partner
Current Status: Phase I

Phase I/IIa trial in stage III/IV NSCLC
CV9202’s predecessor, the RNActive® vaccine CV9201, was previously investigated in 46 patients with locally advanced or metastatic non-small cell lung cancer who did not progress after treatment with first-line chemotherapy or chemoradiotherapy. The safety results of this first exploratory trial suggest that CV9201 has a favorable safety profile with transient, mild to moderate injection site reactions and flu-like symptoms as the predominant related adverse events. It was shown to induce cellular and humoral antigen-specific immune responses in the majority of patients.

The press release on the Phase I/IIa data can be found here.

Phase Ib trial in stage IV NSCLC
The main objectives of this study are to determine whether the therapeutic cancer vaccine BI1361849/CV9202 in combination with local low-dose radiation and maintenance therapy is safe, tolerable and immunogenic for the consolidation and maintenance treatment of stage IV non-small cell lung cancer (NSCLC) in patients not progressing after first-line chemotherapy or during therapy with an EGFR tyrosine kinase inhibitor. All patients receive two initial vaccinations with BI1361849/CV9202 prior to local radiotherapy followed by further vaccinations until disease progression requiring anti-cancer therapy. Treatment with maintenance doses of pemetrexed or with EGFR tyrosine kinase inhibitors are administered depending on the subtype of NSCLC. The study is ongoing as of January 2016.

For further information on this study please visit clinicaltrials.gov.

The press release announcing the start of the collaboration with Boehringer Ingelheim can be found here.

NSCLC (Combination BI 1361849 / CV9202 with Checkpoint Inhibitor)
Pre-clinic
NSCLC (BI 1361849 / CV9202 with PD1 after chemo-radiation)
Pre-clinic
NSCLC (Combination BI 1361849 / CV9202 with Checkpoint Inhibitor)
Pre-clinic
Further undisclosed projects
Research
RNActive® Prophylactic Vaccines
Research
Pre-clinic
Phase I
Phase II
Phase III
Partner
Rabies (CV7201)
Phase I

CV7201 is an mRNA-based vaccine encoding the glycoprotein of rabies virus (RAV-G).

Current Status: Phase I

The study is designed to evaluate the safety and immunogenicity of CV7201 according to (1) dose level (2) route of injection and (3) injection schedule. Rabies-specific binding and neutralizing titers will be evaluated across different injection routes using an injection schedule of 0-7-28 and 0-28-56. Over 100 subjects have been enrolled at the University of Munich, Germany under the supervision of Dr. F.-J. von Sonnenburg.

For further information on this study please visit clinicaltrials.gov.

RSV
Pre-clinic
HIV
Pre-clinic
Influenza
Research
Diverse Projects
Research
Undisclosed project
Research
Further undisclosed projects
Research
RNAdjuvant®
Research
Pre-clinic
Phase I
Phase II
Phase III
Partner
Prophylactic vaccine indication
Phase I

RNAdjuvant® (ribonucleic acid-based adjuvant, CV8102) is investigated for the potential to enhance immunogenicity of vaccines.

Current Status: Phase I

The study includes two phases: (A) evaluation of safety and tolerability of CV8102 at different dose levels given alone, by intramuscular injection and (B) the immunostimulatory effect of the optimal CV8102 dose level from Part A on decreasing dose levels of a licensed vaccine, Rabipur®. 56 subjects were enrolled. The study is being conducted at CRS Clinical Research Services Monchengladbach, Germany under the supervision of Dr. Ingo Meyer. 

For further information on this study please visit clinicaltrials.gov.

Oncological Indication
Pre-clinic
RNArt®
Research
Pre-clinic
Phase I
Phase II
Phase III
Partner
Oncological Indication
Research
RNAntibody®
Research
Further undisclosed projects
Research