Biologics

Overview

Biologics are therapeutics whose mode of action is based on naturally occuring interactions within living animals.

Therapeutic antibodies. Taiga has also developed an innovative method for rapidly generating monoclonal antibodies for treating cancer and infectious disease. Monoclonal antibodies work in the same way natural antibodies work, by identifying and binding to a specific target in the body. They then alert other cells in the immune system to eliminate the antibody bound substance. Development of fully humanized antibodies for the treatment of disease has become a primary focus of Taiga.

THERAPEUTIC ANTIBODY OPPORTUNITY

In recent years, the clinical application of Monoclonal Antibodies (MoAbs) has emerged as a major new source of drugs for cancer therapy. Monoclonal antibodies are naturally occurring proteins of the immune system that attack foreign substances in the body and can be grown and purified in a laboratory setting. As a cancer therapy, once the antibody binds its receptors, it marks the cancer cells as targets of the immune system. Despite the success of antibody therapies in the clinic, the overall approach is limited by the difficulty in generating antibodies to certain protein targets. These limitations include the physiological processes that keep the immune system from making antibodies that recognize proteins from the body (self-proteins), as well as the requirement to be able to fuse an antibody-making cell with a myeloma cell line in order to generate large amounts of the specific antibody. These problems specifically impact on our ability to generate novel antibodies that specifically recognize proteins expressed by tumor cells. We have developed a novel method to generate monoclonal antibodies to any protein we would like, without regard to the limitations involved by tolerance to self-proteins. We have also overcome the need to fuse the antibody-producing cells with a myeloma cell line in order to enable us to produce large amounts of a specific antibody.

Limitations of current technology:

  1. Specificity. Traditional methods used to make MoAbs limit the possible target specificity at several stages.
    • The ability to make an antibody against just any target is limited by regulatory mechanisms that prevent antibody formation against the host’s "self" proteins.
    • The process of generating an antibody-producing cell line requires that the antibody cell reside in a specific point of growth to "fuse" with another cell.
    • These two steps are likely to reduce the number of possible target specificities represented at the end of the process by approximately 90%.
  2. Time. If an antibody can be generated against a specific target, producing a therapeutic product can take years because:
    • Extensive testing is required to identify the one cell that makes the antibody of interest.
    • The elaborate process of changing a mouse antibody into a human antibody. This is also the main source of unforeseen complications that have derailed several clinical trials.

TAIGA'S SOLUTION FOR THERAPEUTIC ANTIBODY PRODUCTION

We have developed a novel method of generating MoAbs that is able to overcome both obstacles and recognize antigenic specificities that would normally be difficult to generate with current technologies. This can be achieved 3-4 times faster than current technologies, which would also enable us to use this approach for the rapid generation of antibodies for emerging infectious diseases.

We discovered that we could force mice to generate antibodies to a "self" target (which are called "autoantibodies") by over-expressing a particular gene in our proprietary stem cells. The progeny cells, called B-cells, become activated and produce copious amounts of autoantibody as a result of their ability to overcome the regulatory mechanisms that normally prevent antibody formation against the host's "self" proteins.

Using this technology, Taiga has the opportunity to develop antibodies against any conceivable target for clinical applications in a variety of indications. Our ability to quickly generate specific antibodies without the need, and problems related to, humanizing antibodies makes our approach unique in the field