LATE-STAGE, PHASE III READY, LEAD PRODUCT (VICINIUM™) ADDRESSES SIGNIFICANT AND NEAR-TERM CLINICAL NEEDS
Vicinium™ is being developed as an intravesicular treatment for non-muscle invasive bladder cancer patients. FDA/EMEA approved Phase III clinical trial design expected to start in 2010.
PROPRIETARY ANTIBODY-BASED DISCOVERY PLATFORM (IDAP)
Viventia offers a comprehensive, integrated R&D engine, IDAP, capable of isolating human antibodies that can be used to identify new targets and/or in the development of antibody-based products against those targets.
- Proprietary target discovery platform successfully applied to identify over 14 oncology drug targets to date, including several novel and proprietary protein variants
- Human immune response used to generate highly specific antibody libraries using proprietary technologies
RAPIDLY ADVANCING A PROPRIETARY ONCOLOGY PIPELINE CONSISTING OF HUMAN MONOCLONAL ANTIBODIES
Viventia has taken two product candidates to the clinic and has several more in preclinical development. The Company’s product candidates represent promising and differentiated new cancer therapies that combine the selectivity of tumor targeting antibodies with the potency of traditional cancer therapies:
- Vicinium™ - Scheduled to commence Phase III clinical trials for non-muscle invasive bladder cancer in 2010
- VB6-845 - Formulated for systemic administration for the treatment of metastasizing solid tumors
CONJUGATED ANTIBODIES WITH A WELL DEFINED, DIFFERENTIATED MECHANISM OF ACTION
Viventia’s Armed Antibody™ approach represents a significant evolution in the field of antibody technology that addresses key current limitations associated with both naked and conjugated antibody approaches. The principal advantages of Viventia’s platform are:
- Small antibody fragments facilitate effective tumor penetration
- Payloads are attached to antibody fragments through recombinant engineering, providing stable conjugations limiting non-specific toxicity
- Tumor-activated payloads are exceptionally potent and are designed to specifically activate within the cell and to remain inert outside the cell
- Proprietary de-immunized payload allows for repeat systemic administration
- Armed Antibody kills target cells directly rather than by relying on the patient’s immune system
cGMP FACILITY PROVIDES ADVANTAGES OF IN-HOUSE CLINICAL STAGE PRODUCTION WITH MANUFACTURING PROCESSES TRANSFERABLE TO COMMERCIAL SCALE PRODUCTION
Viventia’s production facility permits control over product development from bench to bedside and the realization of quality drug product for the purpose of meeting pre-clinical and clinical needs.
- Large production infrastructure, including process development, equipment, utilities and quality systems that allow a streamlined and flexible approach to production flowing rapidly from R&D to manufacturing
- Scalable production processes and capabilities facilitates advancement from the clinic through to late stage (Phase III) clinical development
- Processes are easily transferable to commercial scale production
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