Incentives, IP and Smaller companies: the Story of CureVac
With over 7,000 medicines in development, new treatments will continue to change patients’ lives, slowing disease progression, avoiding illness and reducing overall costs for healthcare systems. But developing a new medicine is a long, complex and risky process with no guarantees of success. Over the coming weeks, we look at a number of new medicines and the role that pharmaceutical incentives (or IP) have played in their development.
By 2050, the world’s population aged 60 years and older is expected to reach 2 billion – a vast leap from the 900 million elderly citizens living across the globe today. With increased longevity and lower birth rates changing the demography in Europe and around the world dramatically, the public health impact of age-related, as well as vaccine-preventable diseases, is growing steadily.
Vaccine-based immunotherapies seek to mobilise a patient´s immune system to fight these diseases. For instance, novel, therapeutic cancer vaccines target proteins that are selectively-expressed or over-expressed by cancer cells as compared with healthy cells, an approach chosen as the “Breakthrough of the year 2013”, by SCIENCE magazine.
CureVac, a biopharmaceutical company headquartered in Tübingen, Germany, has developed an innovative technology for the easy and quick production of safe, efficacious and cost-effective immunotherapeutic agents for a wide range of diseases. CureVac has several vaccines in research and (pre-) clinical development for the treatment of cancer. Additionally, candidates for the prevention of infectious diseases, including an influenza vaccine, are in preclinical development, and a rabies vaccine is currently in a Phase I clinical trial with healthy volunteers. Adjuvant agents for vaccination are stable, have a good preclinical safety profile and enhance the effect of commercially-available vaccines in various animal models.
The pioneering technology and advanced, broad preclinical and clinical pipeline of the company is based on the initial discovery that – contrary to scientific belief at the time – the molecule RNA can be used as a vaccine or therapeutic agent. CureVac is the first company to successfully harness messenger RNA (mRNA) for medical purposes, using natural mRNA as a data carrier to instruct the human body to produce own proteins for fighting a wide range of diseases.
One of the main advantages of mRNA-products is their proven thermostability, offering the possibility of transport and storage without maintaining a cold-chain. This may enable the transportation of life-saving therapies to people worldwide in safe and affordable ways, e.g. to developing countries or remote areas, which often have a high medical need for vaccination.
CureVac can produce any RNA sequence in a quality fit for medical use within just a few weeks. The same manufacturing process can be used to produce up to seven therapeutic agents in parallel in the same production plant. The production of therapeutic agents for orphan diseases could therefore be achieved at a much lower cost than with other biopharmaceutical medication approaches.
EU pharmaceutical incentives play a key role in CureVac’s’s development strategy. The prospect of easier access to the services offered by the EMA, advanced regulatory approval, and significant reductions for regulatory fees and consulting costs through all development phases is an important selection factor for development candidates. Other incentive opportunities, including regulatory data protection, orphan designation and pediatric extension, enable CureVac to drive clinical development of several therapeutic candidates, and to further expand their innovation portfolio, before generating income from marketed products.
For example, despite a very small potential market, the company is working on vaccines to prevent influenza and other diseases in all age groups including children and infants. Orphan designation at the time of marketing authorisation would mean 10 years of market exclusivity in the EU that could be extended to 12 years, according to Paediatric Regulation. These incentives enable the development of products that are important for society, despite relatively low income prospects for the individual company.
The combination of strong IP protection and prospective EU pharmaceutical incentives enables CureVac to continue product development in three different therapeutic areas in parallel. This will help to bring novel treatments for several indications to patients, faster: prophylactic vaccines with a high potential to foster disease prevention for society in general, as well as innovative therapies of high medical need for vulnerable patient populations, such as cancer patients, newborns, children and the elderly, next to patients in developing countries and in remote areas.
Patent protection, in combination with a strong technology platform, manufacturing expertise and capabilities, has helped CureVac raise around $370 million in equity investments to date. Lead investors are dievini Hopp BioTech holding GmbH & Co. and the Bill & Melinda Gates Foundation. It also enabled partnerships with organizations such as Sanofi Pasteur, Boehringer Ingelheim and the International AIDS Vaccine Initiative (IAVI), a global not-for-profit, public-private partnership working to accelerate the development of HIV vaccines. The partnership with Boehringer Ingelheim to develop a therapeutic cancer vaccine (CV9202, for non-small cell lung cancer) started in 2014. In March 2014, CureVac was also awarded the €2 million Vaccine Prize from the European Commission for the RNActive vaccine technology. In particular, the jury acknowledged the fact that mRNA-based vaccines do not require a cold chain during transport and storage.In 2015, the Bill & Melinda Gates Foundation equity investment of $52 million (€46 million) supported the construction of a new Good Manufacturing Practice (GMP) production facility. Two Series F ($110 million and ($29.5 million) capital investment rounds were closed in 2015 and 2016.
In addition to partners’ investments, IP protection has supported grant acquisition and milestone payments. The financing helps the company to advance the clinical development of CureVac’s innovative therapeutic approaches. Incentive opportunities additionally support incentive opportunities also support CureVac’s broad innovation portfolio for next generation therapies and prophylaxis.