CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK

• Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates
• Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 8, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GlaxoSmithKline. The tested multivalent vaccine candidates address all four WHO-recommended flu strains.

"Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu," said Dr. Myriam Mendila, Chief Development Officer of CureVac. "There are still unmet needs as seasonal flu is ever-evolving and immune responses to current vaccines remain a challenge, particularly in older adults. The flexibility, speed and scalability of CureVac's end-to-end mRNA capabilities position us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge."

The combined Phase 1/2 study will evaluate mRNA-based, modified, multivalent influenza vaccine candidates for safety, reactogenicity and immune responses. The first Phase 1 dose selection part is being conducted in the U.S. and Belgium and will feature a licensed flu comparator vaccine.

As previously reported, in CureVac and GSK's ongoing Phase 1 trial in older and younger adults of a monovalent, modified mRNA seasonal flu vaccine candidate, preliminary data showed a favorable tolerability profile and no concerning safety signals. Preliminary immunogenicity data indicated strong hemagglutinin inhibition immune responses in line with a licensed flu comparator vaccine beginning at the lowest tested dose.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac's mRNA technology for different targets in the field of infectious diseases.

CureVac Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

CureVac Media Contact
Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1087
bettina.joedicke-braas@curevac.com

Forward-Looking Statements CureVac

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 N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include statements regarding the completion, size and terms of the proposed public offering. 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.

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SOURCE: CureVac

 

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