Pipeline
Addressing a wide range of medical needs
Our goal is to harness the power of our unique technology to deliver life-saving solutions to patients who need them most. That’s why we’re advancing a focused strategic messenger RNA (mRNA)-based pipeline with an emphasis on 2 key therapeutic areas where we believe we can make a real impact: cancer immunotherapies and prophylactic vaccines.
Pipeline
Oncology
Vaccine type
CVGBM
Off-the-shelf cancer vaccines
Off-the-shelf cancer vaccines
Personalized cancer vaccines
Infectious diseases
Vaccine type
UPEC vaccine candidates
Mulltivalent candidate
Multivalent candidate (B strain optimization)
Multivalent candidate
Monovalent candidate
CV0601/CV0701
Programs
Off-the-shelf cancer immunotherapy candidates
Resected glioblastoma
Glioblastoma is one of the most complex treatment-resistant cancers. The 5-year survival rate for patients with glioblastoma is only 6.9%, and the average survival for such patients after diagnosis is estimated to be only 12 to18 months with therapy.1
Our shared-antigen immunotherapy candidate CVGBM is based on our second-generation mRNA backbone, designed to enhance the translation of mRNA, boost protein production, and improve immune system responses. The vaccine encodes a fusion protein that includes 8 segments derived from 4 tumor-related proteins with known relevance in glioblastoma. These include 5 segments that trigger immune responses through class 1 molecules (HLA-02:01) and 3 segments that trigger immune responses through class 2 molecules. Our candidate uses unmodified mRNA and is delivered within lipid nanoparticles.
In a phase 1 study, preliminary immunogenicity results demonstrated induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy. CVBGM was generally well tolerated up to the highest tested dose level.
Squamous non–small cell lung cancer (sqNSCLC)
Non–small cell lung cancer (NSCLC) is the most common malignancy in industrialized countries, with a 5-year survival rate of only 15%. sqNSCLC is the second most frequent type of NSCLC.2
We selected 4 known and 4 new antigens found across patients that were discovered through our proprietary method beyond the exome. This discovery led to the development of an off-the-shelf mRNA investigational vaccine designed to target these antigens.
A phase 1 study is expected to start in the second half of 2025.
Personalized cancer immunotherapies
We continue to explore the design and production of personalized cancer vaccines based on a patient’s unique genomic profile.
Prophylactic vaccines
Urinary tract infections
Urinary tract infections (UTIs) are a major cause of health care costs, with an estimated $6 billion spent on UTIs worldwide each year.3
We are working on a vaccine to prevent recurrent UTIs by targeting uropathogenic Escherichia coli, the bacteria responsible for most UTIs. We are leveraging mRNA to induce both high antibody titers and T-cell responses to fight off infections before they take hold. Preclinical data show that our mRNA vaccine candidate demonstrates superior immunogenicity compared to protein-based comparator vaccines targeting the same bacterial antigen.
Combination seasonal influenza and COVID-19 (fully licensed to GSK)
The first phase of a combined phase 1/2 study to assess the safety, reactogenicity, and immunogenicity of a seasonal influenza/COVID-19 combination vaccine is currently underway.
Seasonal influenza (fully licensed to GSK)
A phase 2 trial is currently underway to evaluate the reactogenicity, safety, and immunogenicity of a multivalent vaccine candidate. This vaccine encodes antigens that are matched to the 3 flu strains previously recommended by the World Health Organization.
Avian influenza (fully licensed to GSK)
A combined phase 1/2 study is currently underway to evaluate the reactogenicity and immunogenicity of a monovalent investigational influenza A (H5N1) prepandemic vaccine candidate.
COVID-19 (fully licensed to GSK)
A phase 2 study assessing the safety and immunogenicity of different single-booster doses of monovalent vaccine candidate CV0601, which encodes the spike protein of the Omicron BA.4-5 variant, and bivalent vaccine candidate CV0701, which encodes the spike protein of the Omicron BA4-5 variant and the original SARS-CoV-2 virus, is currently under way.
References:
- National Brain Tumor Society. About glioblastoma. National Brain Tumor Society. Accessed February 17, 2025. https://braintumor.org/events/glioblastoma-awareness-day/about-glioblastoma/
- Barletta E, Federico P, Tinessa V, et al. Long-term survival in a patient with metastatic squamous cell lung carcinoma: a case report. Mol Clin Oncol. 2017;7(5):928-930. doi:10.3892/mco.2017.1408
- Mann R, Mediati DG, Duggin IG, Harry EJ, Bottomley AL. Metabolic adaptations of uropathogenic E. coli in the urinary tract. Front Cell Infect Microbiol. 2017;7:241. doi:10.3389/fcimb.2017.00241