GSK and CureVac to develop next generation mRNA COVID-19 vaccines

For media and investors only

Issued: London, UK/ Tübingen, Germany/ Boston, MA, USA

• Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use
• Development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval
• GSK will also support manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine CVnCoV in 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

GSK will also support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021.

Through this new exclusive co-development agreement, GSK and CureVac will contribute resources and expertise to research, develop, and manufacture a number of novel mRNA vaccine candidates, including multi-valent and monovalent approaches. The aim of this work is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development programme will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval.

The increase in emerging variants with the potential to reduce the efficacy of first generation COVID-19 vaccines requires acceleration of efforts to develop vaccines against new variants to keep one step ahead of the pandemic. These next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time. In addition, the collaboration will assess the development of novel mRNA vaccines to protect against multiple respiratory viruses, including COVID-19.

This collaboration will build on CureVac’s first generation COVID-19 vaccine candidate CVnCoV, which is currently in Phase 2b/3 clinical trial and on CureVac’s ability to optimise mRNA for a strong immune response, manufacturability, and stability at standard 2-8°C cold chain conditions for vaccines. CureVac’s platform is uniquely adapted to designing multi-valent vaccines with a balanced immune response and a low dose of mRNA.

Emma Walmsley, Chief Executive Officer, GSK, said: “We believe that next generation vaccines will be crucial in the continued fight against COVID-19. This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates. At the same time, we will also support the production of CureVac’s first generation vaccines with the manufacture of 100 million doses in 2021.”

Franz-Werner Haas, Chief Executive Officer of CureVac, said: “We are very pleased to build on our existing relationship with GSK with a new agreement to jointly develop next generation mRNA-based vaccines, in addition to our current candidate CVnCoV. With the help of GSK’s proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines.”

As part of the new collaboration, GSK will also support manufacture of CureVac’s first-generation COVID-19 vaccine candidate CVnCoV which is currently in Phase 2b/3 trials. Using its established manufacturing network in Belgium, GSK aims to support manufacturing of up to 100 million doses of the vaccine in 2021.

Under the terms of the new collaboration agreement, GSK will be the marketing authorisation holder for the next generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialise the next generation COVID-19 vaccine in all countries with the exception of Germany, Austria and Switzerland. GSK will make an upfront payment of €75m and a further milestone payment of €75m, conditional on the achievement of specific milestones.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

About CureVac

CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. In January 2021 the company entered into a collaboration and services agreement with Bayer. CureVac is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com/.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

CureVac Forward-Looking Statements

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potency efficacy of the company’s vaccine candidate and the company’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.