CIMAvax-EGF is composed of recombinant human epidermal growth factor (EGF) conjugated to a protein carrier.
[2] The vaccine was developed by the Center of Molecular Immunology, Havana, Cuba, and made available to the Cuban population in 2011.
The EGF is chemically linked to the Neisseria meningitidis outer protein P64k for immunogenicity;[2] Montanide ISA 51 is used as an adjuvant to potentiate the immune response.
[10] Cyclophosphamide is thought to temporarily block the body's natural immune tolerance to EGF, thereby increasing antibody titers.
[10] Researchers caution that the early results to date have been in relatively small, early-stage trials with patients that were carefully selected based on predefined inclusion and exclusion criteria, and given specialized oncology care; they may therefore not be representative of most patients who might benefit from the vaccine.
[18] In September 2018, Principal Investigator Grace Dy shared the initial results of the first Roswell Park trial.
[20] An ongoing Phase II clinical trial (clinicaltrials.gov identifier NCT02955290) has been expanded to include patients with advanced, recurrent head and neck squamous-cell carcinoma, as well as patients with advanced NSCLC but with high PD-L1 levels, who will be treated with pembrolizumab in combination with CIMAvax instead of nivolumab.