Daniel Menichella, CEO of biopharmaceutical company CureVac, was today invited to the White House to discuss strategies and opportunities for the rapid development and production of a coronavirus vaccine with U.S. President Donald Trump, Vice President Mike Pence, members of the White House Coronavirus Task Force and high-ranking representatives of pharmaceutical and biotech companies working on the outbreak’s response.
In the discussion, Menichella highlighted the potential of CureVac’s mRNA platform for vaccine development based on mRNA technology. “We are very confident that we will be able to develop a potent vaccine candidate within a few months, said CureVac CEO Daniel Menichella. “We can rely on the data of a Phase 1 rabies study in which we were able to immunize all participants with a very low dose. On this basis, we are working intensively to achieve a very low dose for the CoV vaccine as well. In addition, CureVac has a GMP-certified production facility which enables us to produce up to ten million vaccine doses in one production run.”
CureVac is currently selecting the most suitable vaccine candidates from several constructs based on quality criteria and biological activity. In parallel, the company is coordinating the development of its program with the German Paul Ehrlich Institute (PEI) for accelerated clinical development of these vaccine candidates and is in discussions with other European health authorities. These steps will enable the start of clinical trials in early summer 2020. Two primary study centers have already been identified and are in preparation.
CureVac began development of its first mRNA-based vaccine in 2011 and has extensive experience in this field. The company has received financial support for these developments from the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, as well as from the Bill and Melinda Gates Foundation and the international vaccine initiative CEPI.
In the Phase 1 rabies study reported in January, CureVac was able to induce immune responses in humans with the extremely low dose of only 1 microgram. If this is shown to apply to a coronavirus vaccine, millions of vaccine doses could potentially be produced at low costs in existing CureVac production facilities.
CureVac’s platform aims to optimize the properties of mRNA therapeutics and vaccines. The technology can be tailored to induce varying degrees of immune responses against antigens of choice, potentially providing potent prophylactic vaccines for the prevention of infectious diseases, such as rabies, as well as immunotherapies for the treatment of cancer. The technology can also be adapted to avoid such immune activation for purposes of molecular therapies, thereby providing potential new therapeutic modalities for patients suffering from rare diseases.
