CureVac Announces Financial Results for the First Quarter of 2023 and Provides Business Update - Seite 2

Selected Business Updates

Prophylactic Vaccines

Executing on Broad Second-Generation mRNA Vaccine Program, Jointly Developed with GSK

CureVac continues to advance its broad clinical development program in prophylactic vaccines in colla­boration with GSK. Positive preliminary data reported in early 2023 from Phase 1 studies with modified, monovalent mRNA candidates in COVID-19 and flu provided strong validation of CureVac's mRNA technology platform. All jointly tested candidates are based on CureVac's proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses. The second-generation mRNA backbone is expected to enable protection against one or more emerging COVID-19 variants or multiple strains of other infectious diseases, such as flu, with potential for combination vaccines against multiple different viruses as well.

The flu clinical development program was broadened on May 8, 2023, when dosing of the first participant was announced in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates. The study evaluates flu vaccine candidates for safety, reactogenicity and immune responses. The first, Phase 1 part of the trial is being conducted in the U.S. and Belgium. The tested multivalent vaccine candidates address all four WHO-recommended flu strains and are compared to a licensed flu comparator vaccine.

Protection of Intellectual Property Rights

Over the last 23 years, CureVac has developed proprietary foundational technology related to mRNA design, delivery and manufacturing that has materially contributed to the development of safe and efficacious COVID-19 vaccines.

On May 19, CureVac announced the granting of its motion to transfer U.S. patent litigation initiated by Pfizer/BioNTech in late July 2022 from the federal district court of Massachusetts to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely 2024 trial date.

The motion to transfer the case is part of a broadened counterclaim CureVac filed on May 19, 2023, that alleges infringement of nine U.S. patents by the manufacture and sale of the SARS-CoV-2 vaccine Comirnaty®: 11,135,312; 11,149,278; 11,286,492; 11,345,920; 10,760,070; 11,241,493; 11,471,525; 11,576,966; and 11,596,686. This significantly expands the scope of the case beyond the three patents for which Pfizer/BioNTech had originally sought confirmation of non-infringement. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design, formulation and manufacturing specific to SARS-CoV-2 vaccines.

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