Strategy for biomarker identification technology

Alacrita’s antibody consultants were engaged to help a start-up company that had developed a suite of proprietary antibody technologies to identify accessible cell surface proteins for discovery of candidate therapeutic mAb targets and/or biomarkers. Although there are a number of techniques described in the literature to probe the “membranome” or the “secretome”, the key advantage of the company’s technology is that it identifies targets that are accessible through serum or interstitial fluid in vivo, with obvious advantages in terms of utility. The technology can be used on very small tissue samples (100,000 cells) and has already generated intellectual property relating to novel oncology targets.

The objective of the consulting project was to assess the commercial attractiveness of the technologies for:

• Identifying new therapeutic targets for mAb drug discovery;
• Applications in the discovery of novel biomarkers for use as potential diagnostic, prognostic and patient stratification tools;
• Developing matched therapeutic target/biomarker packages which could be extremely valuable for drug development in an era when stratified or personalized medicine is becoming popular, especially with payers.

Alacrita’s consultants were asked to provide an external objective appraisal of the commercial attractiveness to help validate the company’s business plan and provide insights into optimising the business development strategy. Our approach focused on the key questions including:

• How robust is the technology and how far does it take a researcher toward a validated target?
• Does the technology meet genuine market unmet needs? Will it bring significant improvements to the number and/or quality of mAb discovery leads?
• What is the competitive position? How does the technology compare with other approaches?
• Is a service offering attractive as a commercialization route?
• If the strategy is to discover novel targets and offer them for sale/license, what degree of target and therapeutic validation would be optimal?

In conducting the research, Alacrita complemented its extensive in-house expertise in antibody R&D with a series of interviews with research and corporate leaders in established monoclonal antibody companies.

Alacrita’s report helped the company refocus its business plan which was then used as the basis for a successful fundraising exercise.