Tübingen spin-out heads to Florida for drug development

Collaboration agreed

Tübingen University spin-out CureVac GmbH has decided to cross the Atlantic in a bid to  enter the US drug market, choosing the Department of Urology at the University of Florida, Gainesville, to work with to bring its lead candidate CV9103 into 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, says the company, the most advanced candidate in its proprietary RNActive-derived range of molecules. It is comprised of modified single-stranded mRNA (messenger RNA) coding for four different antigens expressed by prostate cancer cells. CureVac says that preclinical results provide evidence for its potential to stimulate a potent and specific immune response against the tumour when injected into the skin.

The partners plan to submit an Investigational New Drug application, or IND, to the US Food and Drug Administration – the first step on the regulatory road to approval in the US market. The main aim of an IND application is to provide the data showing that it is reasonable to begin tests of a new drug on humans.

CureVac originated in the laboratory of Professor Hans-Georg Rammensee at Tübingen University where Ingmar Hoerr, then a PhD student and later co-founder of CureVac, showed in 1998 that naked mRNA can generate a strong specific immune response simply by direct injection.

Two years later, CureVac was spun off from Tübingen University in December 2000 to commercialise the potential of mRNA as a therapeutic, with seed financing from Leonardo Venture, Mannheim. Since its inception in 2000 CureVac has raised around €38 million.

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, MD, 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 maximise 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, MD, 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.”