Markets and Product Pipeline Overview

Tolera plans to develop and commercialize therapies for the immune suppression and immune modulation markets; to address unmet medical needs with safer, targeted solutions. These markets include segments such as oncology, autoimmune disease, and transplantation. Currently available therapies often carry significant risk of serious and toxic side effects. As a result, physicians are seeking novel and safer solutions for their patients.

Tolera’s initial focus will be to commercialize a therapeutic monoclonal antibody for the transplantation and oncology markets, while researching and developing related therapies to serve patients who will benefit from safer and more targeted immune suppression, or immune modulation. The company owns an exclusive, worldwide license to this therapeutic antibody. The antibody has been the subject of a number of pre-clinical, Phase I, and Phase II trials. Based on this clinical history, the company believes it has a unique opportunity to bring a safer immune therapy to market.

To further enhance the long term value of the pipeline, the company will continue research and development of Dr. Siemionow’s immune modulation discoveries, which offer promise for commercialization of additional novel therapeutics in autoimmune, oncology and transplantation. The company may also seek to in-license additional safer or more effective technologies aimed at these, and other valuable clinical markets.

Pipeline
Tolera’s near term objective is to apply its therapeutic monoclonal antibody therapies to two valuable market segments (transplantation and oncology), and to address current unmet medical needs for safer, more targeted immunosuppression and enhanced tolerance of donor organs and bone marrow.

Induction of tolerance studies at the Cleveland Clinic have led Dr. Siemionow to new discoveries in applying cell therapy to modulating the immune response in order to permit a broader range of tissue transplantation between mismatched donors and recipients. These discoveries may have broad implications for immune modulation beyond tissue and organ transplantation and may provide new solutions for autoimmune disease and oncology. The company plans to further develop and commercialize these discoveries.

 

The Pipeline
TOL101	Anti-rejection and Induction in transplantation
TOL102	Novel oncology therapies
Cell Therapy	Immune modulation to address multiple autoimmune, oncology and transplant needs
Other technologies	The company will seek to develop or license other novel technologies that offer the promise of safer and more effective immune support, modulation, or suppression.