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July 30, 2015 3:15 PM ET

Pharmaceuticals

Company Overview of CureVac GmbH

Company Overview

CureVac GmbH, a biopharmaceutical company, develops therapeutic messenger RNA vaccines for cancer and prophylactic vaccines for infectious diseases. The company provides RNActive molecules as immunotherapeutics for the treatment of cancer and as prophylactic vaccines against infectious diseases. It also develops adjuvants based on non-coding RNAs (RNAdjuvant) for enhancing the immune response of other vaccines. CureVac GmbH has strategic partnership with Janssen Pharmaceuticals, Inc. and Sanofi Pasteur S.A. The company was founded in 2000 and is based in Tubingen, Germany.

Paul-Ehrlich-Straße 15

Tubingen,  72076

Germany

Founded in 2000

Phone:

49 70 71 9 20 53 100

Fax:

49 70 71 9 20 53 101

Key Executives for CureVac GmbH

Founder, Chief Executive Officer, Managing Director and Head of Business Development
Co-Founder and Chief Operating Officer
Chief Corporate Officer
Chief Medical Officer
Head of Human Resources
Compensation as of Fiscal Year 2015.

CureVac GmbH Key Developments

CureVac Announces Phase I/IIa Clinical Study Data of its mRNA Cancer Immunotherapy in Prostate Cancer

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. 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 six-transmembrane epithelial antigen of the prostate 1 (STEAP1). 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 antigen-specific 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.

CureVac Announces Study Publication in Molecular Therapy Demonstrating Wide-Ranging Benefits of Sequence-Optimized, Unmodified MRNas

CureVac announced that a study of its RNArt technology platform was published in Molecular Therapy as an advanced article preview. The peer-reviewed study that was carried out in collaboration with Acuitas Therapeutics demonstrated for the first time that sequence-optimized, chemically unmodified mRNAs raised relevant protein levels in non-human primates without stimulating an unwanted immune reaction, indicating that mRNA achieves meaningful biological effects in large animals with body weight close to humans. Moreover, the study suggested that sequence-optimized, unmodified mRNAs offer advantages when compared to chemically-modified mRNAs, including more efficacious protein translation. In the study, titled "Sequence-Engineered mRNA Without Chemical Nucleoside Modifications Enables an Effective Protein Therapy in Large Animals," investigators used erythropoietin (EPO) driven production of red blood cells as the biological model. Data demonstrated that sequence-engineered mRNA encoding EPO elicited meaningful physiological responses from mice to non-human primates, such as a considerable increase of serum EPO levels and reticulocyte counts, as well as a significant rise in hematocrit. Even in pigs of approximately 20 kg in weight, a single dose of engineered mRNA encapsulated in lipid nanoparticles induced high systemic EPO levels and strong physiological effects. There was neither cytokine release nor induction of EPO-specific antibodies upon repeated treatment. The study also compared sequence-engineered, unmodified mRNA to various chemically-modified mRNAs, including mRNA from a commercial supplier. As suggested by protein levels and physiological responses, the sequence-engineered mRNA outperformed its modified counterpart. Thus, the present study proves that protein (replacement) therapies are possible with mRNA, without any need for chemical modifications. The company's sequence engineering technology can be applied to any protein of interest, including complexes such as antibodies. Currently the company applies this technology, RNAntibody, in collaboration with the Defense Advanced Research Projects Agency for passive immunization with protecting antibodies encoded on mRNA.

CureVac GmbH Presents at BioEquity Europe 2015, May-19-2015 05:40 PM

CureVac GmbH Presents at BioEquity Europe 2015, May-19-2015 05:40 PM. Venue: InterContinental Vienna, Vienna, Austria.

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