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Wittycell has its first GMP candidate, WTCc, with complete documentation, available for clinical trial.

The manufacturing Scale-up has been completed and is feasible for Kg scale synthesis. A first clinical batch has been manufactured (60 grams), and released under GMP conditions. The product is being formulated under the same GMP conditions (European standards). The stability study is ongoing for the WTCc in powder (6 months data available). GLP toxicity studies are being conducted in mice and monkey in accordance with ICH Topic M3 (R2) and  CPMP/VEG/2004 V5, for WTCc alone and with HBsAg



WTCc is a new “ready to use” adjuvant , which enables vaccine developers and producers to  :

Improve vaccine performance (marketed or in development)

• Increase immunogenicity, in particular cytotoxic enhancement
• Reduce dose (antigen sparing)
• Compatible with antigens (peptide, protein, others)
• Synergistice with other immunopotentiators and delivery system
• Reduction from multi-doses to a single dose
• Improvement in route of delivery (from injection to mucosal)
• Provide improved protection in dedicated populations (e.g. the elderly)
• Provide rapid on-set of protection with long term efficacy (memory)

Optimize formulation & manufacturing

• Solubility in aqueous and non-aqueous media
• Temperature resistant formulations
• Formulation compatible with polyvalent vaccines
• Simple large scale manufacturing process (million doses)
• Clear and recent IP on the molecule and its application

 Fulfill regulatory requirements

• Good safety profile of the adjuvant alone and in combination with the specific vaccine
• Drug Master File ready for registration