SBIR Phase I: Automated Humanization of Antibodies Directed to Protein and Carbohydrate Antigens

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project will be to develop an online, fully automated platform for designing high-affinity antibodies for use as potential drug candidates. The success of antibody-based drugs has generated interest in faster and more efficient methods to discover and optimize antibodies. The goal of this project will be to develop and implement a computation method for producing protein sequences of humanized antibodies. This will be achieved by providing software that allows scientists to move some of their initial experiments into the cloud, and achieve results much more quickly by using computational methods. The typical experiments that will be replaced by this method take about a month of time and cost tens of thousands of dollars. With the aid of such a method, this time can be cut back to the click of a button. The expected savings in time and cost for new drug development will improve the features of drug candidates, enhancing the success rate of clinical studies, and accelerating the commercialization of new drugs. This SBIR Phase I project proposes the development of a platform for antibody design that maximizes human content, retention of affinity, enhancement of developability, and generation of intellectual property. Immunogenicity is a critical concern when developing an antibody-based drug. Humanization is designed to increase the human content of an antibody originally obtained from sources other than human, such as mouse or rabbit hybridomas. The objective is to simplify the design of humanized antibodies, which currently involves many labor-intensive steps. The strategy is to offer clients online prediction services precisely designed and focused on antibody analysis. Secondly, the goal is to address the emerging need for humanizing antibodies directed against both protein and carbohydrate antigens. Current prediction software is biased towards training series that are specific for protein antigens. The plan is to use a pool of anti-Burkholderia mouse monoclonal antibody candidates have been derived from protein and carbohydrate targets. This will result in the ability to assess the utility of the training series under development to perform humanization of antibodies directed against both classes of antigens, and use the information obtained to further optimize prediction procedures.