Antibodies to watch in 2010

Area of Science:

• Biotechnology
• Pharmacology
• Clinical Trials

Background:

• Monoclonal antibodies (mAbs) represent a significant and expanding category of therapeutic agents, with over 25 already approved globally.
• The development pipeline is robust, featuring approximately 240 mAb therapeutics in clinical studies, with nearly 40 new molecules entering study annually.
• A key focus is on the 26 mAbs currently in Phase 3 clinical trials, the critical stage for generating safety and efficacy data required for regulatory approval.

Purpose of the Study:

• To provide an overview of 26 monoclonal antibody candidates currently in Phase 3 clinical studies.
• To briefly describe the background and ongoing Phase 3 studies for each selected mAb.
• To establish a baseline for future progress assessment in mAb therapeutic development.

Main Methods:

• Review of 26 monoclonal antibodies (mAbs) in Phase 3 clinical trials as of October 2009.
• Inclusion criteria focused on mAbs in Phase 3, excluding those already approved or under regulatory review, and Fc fusion proteins.
• Literature review with a focus on recent publications relevant to Phase 3 studies.

Main Results:

• Identification and description of 26 mAb candidates in Phase 3 development.
• Phase 3 study durations are typically 2-4 years, with results anticipated between 2010 and 2014.
• The overview serves as a reference point for tracking the progress of these critical therapeutic candidates.

Conclusions:

• The significant number of mAbs in Phase 3 trials highlights the dynamic growth of this therapeutic class.
• The data presented provides a snapshot of the mAb landscape in late-stage development as of late 2009.
• This review will aid in monitoring the progression and eventual approval of these important new medicines.