mRNA-Based Cancer Immunotherapies

Resected Glioblastoma

Unmodified multi-epitope cancer vaccine candidate

Based on CureVac’s proprietary second-generation mRNA backbone, designed for improved mRNA translation, increased protein expression and optimized induction of T-cell responses, CVGBM encodes a single fusion protein comprising eight epitopes derived from four tumor-associated antigens (TAA) with relevance in glioblastoma, including five HLA class I (HLA-*02:01) epitopes and three class II epitopes. CVGBM applies unmodified mRNA and is formulated within lipid nanoparticles (LNPs). The Phase 1 proof-of-principle study of CVGBM is currently being conducted in Germany, Belgium and the Netherlands.

More information can be found at clinicaltrials.gov (NCT05938387).

Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Applying antigens from proprietary discovery and from our cooperation with myNEO Therapeutics

Off-the-Shelf Cancer Vaccine Candidates

Not disclosed

Off-the-shelf cancer vaccines target tumor antigens shared across different patient populations and/or tumor types

Personalized Cancer Vaccine Candidates

Not disclosed

Personalized cancer vaccines are based on a patient’s individual tumor genomic profile

mRNA-Based Prophylactic Vaccines

Urinary Tract Infections caused by Uropathogenic Escherichia Coli (UPEC)

Seasonal Influenza

Modified multivalent vaccine candidate(B strain optimization)

Fully licensed to

The Phase 2 study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended flu strains. The study includes 250 healthy younger adults aged 18 to 64 and 250 healthy older adults aged 65 to 85. In each age group, different dose levels are being tested in comparison to an age-appropriate, licensed comparator vaccine.

More information can be found at clinicaltrials.gov (NCT06431607).

Seasonal Influenza

Modified multivalent vaccine candidate

Fully licensed to

The Phase 2 dose-confirmation part of the combined Phase 1/2 study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to the four previously WHO-recommended flu strains. Reactogenicity, safety, and immunogenicity are being assessed in 480 healthy younger adults aged 18 to 64 and 480 healthy older adults aged 65 to 85. In each age group, three different dose levels are being tested in comparison to an age-appropriate, licensed comparator vaccine. For younger adults, immune responses are compared to a standard dose seasonal vaccine. For older adults, immune responses are compared to a high dose seasonal flu vaccine.

More information can be found at clinicaltrials.gov (NCT05823974).

Avian Influenza

Modified monovalent vaccine candidate

Fully licensed to

The combined Phase 1/2 study evaluates the safety, reactogenicity and immunogenicity of a monovalent investigational influenza A (H5N1) pre-pandemic vaccine candidate in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85. In the Phase 1 part of the study, up to five dose levels are being assessed compared to a placebo control. The Phase 2 part of the study assesses the immunogenicity, reactogenicity, and safety of the same 5 dose levels evaluated in Phase 1, with the aim of identifying the doses to proceed to Phase 2 Part B.

Phase 2 Part B will evaluate the reactogenicity, safety, and immunogenicity of either up to 2 dose levels selected from Phase 2 Part A (Scenario 1), or up to 2 higher dose levels (Scenario 2) in a one dose

The study is being conducted in the United States.

More information can be found at clinicaltrials.gov (NCT05823974).

COVID-19

Fully licensed to

The Phase 2 study assesses the safety and immunogenicity of different single booster doses of monovalent vaccine candidate CV0601, encoding the spike protein of the Omicron BA.4-5 variant and bivalent vaccine candidate CV0701, encoding the spike protein of the Omicron BA.4-5 variant and original SARS-CoV-2 virus. Safety and immunogenicity are assessed in comparison to a licensed bivalent mRNA-based COVID-19 comparator vaccine. While the monovalent candidate CV0601 is tested at a single medium dose level, the bivalent candidate CV0701 is tested at low, medium, and high dose levels. The study is being conducted in Australia and is fully enrolled with 427 healthy adults aged 18 and older equally randomized between dose groups.

More information can be found at clinicaltrials.gov (NCT05960097).

Combination Seasonal Influenza and COVID-19

Fully licenced to

Molecular Therapies

Cas9 Gene-Editing

Therapeutic Antibodies