Antibodies to watch in 2019

Area of Science:

• Biologics and therapeutic antibodies
• Drug development and regulatory affairs

Background:

• The annual 'Antibodies to watch' series tracks late-stage antibody therapeutic development.
• The 10th anniversary and Nobel Prizes highlight the relevance of antibody research.

Purpose of the Study:

• To provide an overview of commercial antibody therapeutic development.
• To analyze approval success rates for antibody therapeutics.
• To identify key antibody candidates for future monitoring.

Main Methods:

• Data compilation on antibody therapeutics in clinical development and regulatory review.
• Analysis of approval numbers and success rates by therapeutic area.
• Identification of late-stage pipeline candidates, particularly immune checkpoint modulators and antibody-drug conjugates.

Main Results:

• Record numbers of antibody therapeutics entering clinical studies and receiving approval.
• A robust pipeline with over 570 antibody therapeutics, including 62 in late-stage studies.
• Phase 1 to approval success rates of 17-25% (cancer vs. non-cancer).
• 12 antibody approvals in the EU/US in 2018, with more anticipated.
• Half of the late-stage cancer pipeline comprises immune checkpoint modulators or antibody-drug conjugates.

Conclusions:

• The field of antibody therapeutics is experiencing unprecedented growth and success.
• The commercial pipeline for antibody drugs is strong and diverse.
• Success rates suggest a positive trend for antibody-based treatments, especially in oncology.