Antibody-based therapeutics to watch in 2011

Area of Science:

• Biotechnology
• Pharmacology
• Immunology

Background:

• Monoclonal antibodies (mAbs) and Fc fusion proteins represent advanced therapeutic modalities.
• The development pipeline for these biologics is rapidly expanding.
• Tracking progress is crucial for understanding the evolving landscape of antibody-based treatments.

Purpose of the Study:

• To provide an overview of 25 monoclonal antibody (mAb) and 5 Fc fusion protein therapeutics.
• To summarize recently published clinical study results and ongoing Phase 3 studies.
• To establish a baseline for measuring future advancements in antibody-based therapeutics.

Main Methods:

• Compilation of a watch list of therapeutic antibodies and Fc fusion proteins.
• Inclusion of commercially-sponsored candidates in Phase 2/3 or 3.
• Emphasis on recent publications relevant to Phase 3 studies, excluding approved or under regulatory review products.

Main Results:

• Detailed descriptions of 25 mAb candidates including AIN-457, brentuximab vedotin, and trastuzumab emtansine.
• Descriptions of 5 Fc fusion protein candidates including aflibercept and Factor VIII-Fc.
• Summary of clinical study results and Phase 3 progress for selected therapeutics as of September 2010.

Conclusions:

• The presented information serves as a benchmark for the development of antibody-based therapeutics.
• Ongoing Phase 3 studies indicate significant progress in the field.
• This overview facilitates the monitoring of future advancements in mAb and Fc fusion protein therapies.