Incentives, IP and smaller companies – the story of CureVac

18 Oct 2017

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How CureVac helps to change patients’ lives

CureVac, a biopharmaceutical company headquartered in Tübingen, Germany, has grown from three original founders in 2000 to a mid-size company of about 310 employees in 2017.

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.

The impact of the CureVac product candidates on patients, families, healthcare systems and society

CureVac’s technology represents a novel technology for easy and quick production of safe, efficacious and cost-effective vaccines with high specificity in a wide range of diseases. CureVac already has several active ingredients in research and (pre-)clinical development for the treatment of cancer and for protection against several infectious diseases.

Cancer immunotherapy intends to mobilize a patient’s immune system to fight the disease. Therapeutic cancer vaccines target proteins that are selectively expressed or overexpressed by cancer cells compared to healthy cells. This approach was chosen as the “Breakthrough of the year 2013” by SCIENCE magazine.

Several vaccine candidates for the prevention of infectious diseases, including an influenza vaccine, are in preclinical development. In addition, CureVac is currently testing a rabies vaccine in a Phase I clinical trial with healthy volunteers. This was the first time a prophylactic vaccine was brought to the clinic.

CureVac has recently also developed a novel, RNA-based adjuvant for vaccinations. It is very stable, has a good preclinical safety profile and enhances the effect of commercially available vaccines in various animal disease models. Several conserved antigens can be combined with the adjuvant. This may form the basis for optimized and more broadly protective vaccines. The novel adjuvant also improves the immunogenicity of protein or peptide based vaccines, resulting in potent anti-tumoural immune responses.

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, allowing for prompt availability of vaccines in the event of a pandemic. The same manufacturing process can be used to produce up to seven therapeutic agents in parallel in the same production plant. Production of therapeutic agents for orphan diseases could therefore be achieved at much lower cost than with other biopharmaceutical medication approaches.

IP rights and EU incentives enable continued innovation for patients of all ages 

CureVac has secured a number of patent families with key patents in:

  • PureMessenger® technology (patent protection for scalable purification for production of mRNA for therapeutic use);
  • RNAntibody® technology (patent protection for mRNA-encoded therapeutic antibodies);
  • Vaccination of newborns and infants with mRNA coding for an antigen of a pathogen, particularly of Influenza Virus ;
  • Vaccination of the elderly with mRNA coding for an antigen of a pathogen, particularly of Influenza Virus ;
  • Combination of mRNA vaccines with anti-PD-1 antibodies (a vaccine/inhibitor combination for the prevention or treatment of cancer and infectious diseases).

This strong patent protection plays a key role in the development of the company’s broad portfolio, and in bringing several products to the clinical stage. In the 17 years since its foundation the company has not had revenues from products, while incurring very high operational cost for growing staff, offices, laboratories and research equipment, and for clinical studies. By mid-2017, CureVac had tested its mRNA-based products in eight clinical studies with about 450 human patients and healthy volunteers and has received clinical trial approvals in 10 European countries, Asia and the US.

The patent protection, in combination with their 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.

For example, 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[1] ($110 million and ($29.5 million) capital investment rounds were closed in 2015 and 2016.

Their partners’ investments and milestone payments and grants received are also based on the IP protection. They help CureVac to advance the clinical development of their innovative therapeutic approaches.

Incentive opportunities support CureVac’s broad innovation portfolio for next generation therapies and prophylaxis

EU pharmaceutical incentives also play a key role in the company’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 paediatric 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 which 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.

[1] external round of capital from investors; capital is used to substantially ramp up existing operations and move the company into a significant position in the industry.

*Photos by courtesy of Curevac

2018-06-20T14:43:29+00:00October 18, 2017|