The CIGB Product and R&D Pipeline

The production of the hepatitis B vaccine has allowed the Cuban Ministry of Health to comply, since 1992, with the recommendations of the World Health Organization (WHO) that all countries should introduce universal hepatitis B vaccination into their immunization programs. After 12 years of worldwide clinical experience, this vaccine has shown to be highly immunogenic, with excellent safety and efficacy profiles to protect against HBV infection. Other alternatives to hepatitis B vaccination are also currently under research at the CIGB. On the other hand, despite advances in antiviral therapies, there is still no effective treatment for hepatitis B infection and for this reason; the second strategy has been directed to the development of new drugs that could be used in the therapy of HBV infected patients. Hepatitis C virus (HCV) is also a major worldwide health problem and a DNA vaccine formulation based on a construct comprising the genes for the three main structural antigens of the virus has been generated.

As a result of the collaboration between Havana University and the CIGB, a new conjugated vaccine, for the active immunization against invasive illnesses caused by the bacterium Haemophilus influenzae type b, has been developed. The vaccine differs from those already available in its composition, which is based on synthetic oligosaccharides that mimic the natural capsular polysaccharide, conjugated with the tetanus toxoid carrier protein. The vaccine is immunogenic, safe and very well tolerated, as demonstrated in several clinical trials with children.

The institution is working on a wide program for developing combined vaccines. This includes bivalent HB-Hib, tetravalent DPT-HB, pentavalent DPT-HB+Hib, and other combinations. A clinical trial with the pentavalent DPT-HB+Hib vaccine was successfully performed and national registration was granted and in the next year a clinical trial with a liquid pentavalent vaccine will be started, in which all the antigens are mixed in a single vial. The application of these combined vaccines in Cuba will reduce the number of injections from 11 to 5, and could also contribute to reduce the costs of WHO immunization programs.

Table 1. The CIGB's Biomedical pipeline

Project
Area
Discov.
Preclin.
Phase I
Phase II
Phase III
Approval
Heberprot-P
Wound healing
            
HBV vaccine NASVAC
Infectious
HCV vaccine CIGB-230
Infectious
CIGB-500 Cytoprot. agent
Cardiovascular
CEA recombinant antibody fragment CIGB-M3
Cancer
HPV vaccine
Cancer
Prostate cancer vaccine
Cancer
CIGB-370 (anti-tumor agent)
Cancer
CIGB-166 (anti-VEGF antibody)
Cancer
CIGB-247 (VEGF vaccine)
Cancer
CIGB-552 (anti-tumor peptide)
Cancer
Dengue vaccine
Infectious
Dengue anti-viral molecules
Infectious
CIGB-845 (neuro-protective agent)
Neurology
Peptide for Rheumatoid Arthritis
Autoimmunity

Abbreviations/notes: HB - hepatitis B, VEGF - vascular endothelial growth factor, HBV - Hepatitis B virus, NASVAC - a nasal vaccine candidate for chronic Hepatitis B immunotherapy, HPV - human papilloma virus, HCV - hepatitis C virus, CEA - anti-carcinoembryonic antigen.

Table 2. The CIGB's Agriculture pipeline

Project
Area
Research
Development Pilot Scale
Parcel
National Extension
Acuabio I
Aquiculture
        
Monosex Tilapia
Aquiculture
Hebernem
Agriculture
Biopharming
Agriculture
Swine classical fever vaccine
Agriculture
Rabbit hemorrhagic disease vaccine
Agriculture
FOS
Functional food
Acuabio 3
Aquiculture
 


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