Vaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease

Vaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease

- Sanofi reaffirms ambition to deliver >€10bn in annual vaccines sales by 2030, fueled by an accelerated pace of innovation

- Intent to start at least 5 innovative Phase 3 vaccine programs by 2025

Paris, June 29, 2023. Today Sanofi is hosting a Vaccines Investor Event dedicated to its pipeline with key members of its leadership team. The event will highlight how Sanofi’s strategy is supported by vaccines R&D. Since 2019, reinvesting in key growth drivers and a renewed pipeline has positioned the company well as it moves at speed on the second phase of its Play to Win strategy.

Sustained growth in the vaccines business will be driven by core franchises of influenza, meningitis, and pediatric vaccines, with the addition of a best-in-class RSV franchise that aims to protect infants, toddlers and older adults. Sanofi has made strides in bolstering its vaccines R&D, including the rapid development of a leading-edge mRNA platform, coupled with a global footprint of industrial and commercial expertise.

Executive Vice President, Vaccines, Sanofi

Today, we’re pleased to showcase how vaccines R&D is significantly contributing to the continued growth of the company through the design, development, and delivery of vaccines that address unmet needs. The pace of our innovation is buoyed both by a sense of urgency to address existing public health needs at multiple stages in life, and by our continued transformation as a company that simply won’t accept ‘good enough.

In less than two years, Sanofi has delivered a competitive mRNA platform with improved potency and thermostability that performs with both viral and bacterial targets. Using a powerful internal and external innovation ecosystem, Sanofi’s mRNA Center of Excellence has accelerated the science of mRNA technology, including improved lipid nanoparticles.

Global Head of Vaccines R&D, Sanofi

With the addition of mRNA, we now have the largest development toolbox in the industry. This allows us to tackle public health challenges like RSV across multiple stages of life, applying the right platform to the right age group. Adding machine learning and antigen design means that our future vaccines will raise the bar beyond today’s high standards. With a clear focus on delivering only first- and best-in-class vaccines, we’re wholly focused on innovative R&D and flawless execution.

New data from 12 assets in Sanofi’s broad vaccines pipeline will be featured today:

- Latest data from across the RSV development program, including Phase 3b HARMONIE data for Beyfortus (nirsevimab), specifically designed to protect all infants against RSV when entering their first season; positive Phase 1/2 data from the first RSV vaccine designed to protect toddlers (SP0125); and positive Phase 1/2 results from the RSV mRNA vaccine in older adults (SP0256), which lays the foundation for clinical investigation of a combination vaccine with up to three different pathogens (for example, Respiratory Syncytial Virus, human Metapneumovirus, Parainfluenza virus) for older adults.

- First data from the mRNA Flu Quadrivalent vaccine, and promising results of the next-generation neuraminidase-encoding mRNA Flu vaccine, supporting further development of this novel program.

- Latest data from the Phase 1/2 pediatric pneumococcal vaccine program (SP0202/ developed in collaboration with SK Biosciences), with positive safety and immunogenicity of the first PCV21 vaccine, designed to extend protection against disease with an innovative carrier that breaks the glass ceiling of serotype compositions. Phase 3 start of pediatric pneumococcal vaccine planned in H1 2024, with expected submission for approval in 2027.

- Sanofi will share recent clinical evidence reinforcing MenQuadfi’s best-in-class profile and unique ready-to-use syringe​ in the fight against meningitis. FDA submission of MenQuadfi first and only ready-to-use syringe scheduled for July 2023, with expected launch in 2024. In addition, positive Phase 1/2 results from the Men B program (SP0230) will be presented, supporting a move to the next phase of development.

- In the realm of new frontiers, Sanofi will introduce initial data from its multi-antigen chlamydia vaccine candidate, which will move to Phase 1/2 in early 2024; and preclinical results with its therapeutic mRNA vaccine candidate against acne, which moves into Phase 1/2 in H2, 2023.

Vaccines Investor Event details

Webcast and presentation will be accessible here.

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected]

Sally Bain | + 1 617 834 6026 | [email protected]

Evan Berland | +1 215 432 0234 | [email protected]

Victor Rouault | + 33 6 70 93 71 40 | [email protected]

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | [email protected]

Arnaud Delépine | + 33 6 73 69 36 93 | [email protected]

Corentine Driancourt | + 33 6 40 56 92 21 | [email protected]

Felix Lauscher | + 1 908 612 7239 | [email protected]

Tarik Elgoutni| + 1 617 710 3587 | [email protected]

Nathalie Pham | + 33 7 85 93 30 17 | [email protected]

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in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.