June 18, 2008 – Tübingen, Germany – CureVac GmbH has entered into a partnership with the Department of Urology, University of Florida, Gainesville, U.S., to jointly advance its lead candidate CV9103 into the clinical development. The alliance covers preclinical studies and a US phase I/II trial in patients with prostate cancer who no longer respond to hormone therapy.
CV9103 is the most advanced candidate in CureVac’s unique family of RNActive®-derived molecules. It is comprised of modified single stranded mRNA (messenger RNA) coding for four different antigens expressed by prostate cancer cells. Preclinical results provide evidence for its potential to stimulate a potent and specific immune response against the tumor when injected into the skin.
“The agreement with the University of Florida represents our first step to the US as the world’s leading pharmaceutical market-place with world-class academic institutions for research and development,” says Thomas Lander, M.D., Managing Director and Chief Medical Officer of CureVac. “We intend to foster the dialogue with clinical experts and regulatory authorities on both sides of the Atlantic in order to maximize the value of our compounds, medically as well as commercially. The collaboration with Dr Vieweg and his team will secure an excellent start, as he combines unique long-standing experience in the evaluation of RNA-based therapeutic vaccines with an extensive clinical network. He has an outstanding international reputation as a leader in the field of prostate cancer immunotherapy.”
“Several studies support the therapeutic potential of mRNA for the treatment of cancer,” says Johannes W. Vieweg, M.D., Professor of Urology and Chairman of the Department of Urology. “This, however, will be the first clinical trial in the US to use the direct application route by simply injecting modified mRNA into the skin. It could reduce the complexity of mRNA-based vaccination, and I am excited to be contributing to its clinical development.”
The partnership agreement was signed yesterday by Dr Lander and Dr Vieweg during a signing ceremony at the University of Florida. The partners intend to submit an IND in the US in summer 2008 and expect to enter clinic in 2009. An additional clinical trial with CV9103 in Europe is planned.
About CureVac GmbH
CureVac is a biopharmaceutical company pioneering a new approach to cancer immunotherapy using messenger RNA (mRNA). Based on a unique body of knowledge around RNA, the team has established proprietary technologies and dedicated infrastructure to create and further develop a growing pipeline of innovative mRNA-based drug candidates. These include, among others:
• RNActive® for the design of modified mRNA serving a broad range of therapeutic applications,
• RNAdjuvant® for the use of RNA as an immune stimulant in different kinds of vaccines,
• PUREmessenger® for the cGMP-production of full-length mRNA.
Based on these integrated capabilities the Company can swiftly advance its drug candidates from research stage into the clinic. For selected candidates, CureVac will enter co-development partnerships with international pharma- or biotechnology companies.
The Company was spun off from Tübingen University in 2000 and has secured approximately €38 mn in private equity.
About the University of Florida
The University of Florida Health Science Center - the most comprehensive academic health center in the Southeast of the United States - is dedicated to high-quality programs of education, research, patient care and public service. The Health Science Center encompasses the colleges of Dentistry, Public Health and Health Professions, Medicine, Nursing, Pharmacy and Veterinary Medicine, as well as the Veterinary Medical Teaching Hospital and an academic campus in Jacksonville offering graduate education programs in dentistry, medicine, nursing and pharmacy. Patient care activities, under the banner UF&Shands, are provided through teaching hospitals and a network of clinics in Gainesville and Jacksonville. The Health Science Center also has a statewide presence through satellite medical, dental and nursing clinics staffed by UF health professionals; and affiliations with community-based health-care facilities stretching from Hialeah and Miami to the Florida Panhandle.
Dr Marijke Barner, CureVac GmbH
Tel: +49 (0)7071 / 920 53 – 61