Tolera Therapeutics, Inc.
350 E. Michigan Avenue
Business Summary: Tolera is a Kalamazoo, Michigan based company with a highly specific T-cell antagonist monoclonal antibody technology (anti-TCR) with broad application potential in T-cell mediated disease such as transplant rejection, autoimmune disease (e.g. type 1 diabetes) and hematological malignancies (e.g. pediatric ALL). It has been clinically proven effective and safe in previous human studies. It is ready for later stage trials and near-term market approval.
Management: Tolera is managed by an experienced biotech team and supported by an extensive network of development and clinical experts. The CEO, John Puisis has experience as CEO of a publicly traded biotech company and has over 20 years experience in biotech. Tolera has the support of the Cleveland Clinic, the University of Michigan, and Northwestern University, advising on the market’s unmet needs and clinical development strategies.
Unmet Medical Need: Current T-cell antagonists operate as either overly broad spectrum, toxic agents, or as overly specific and less effective immune inhibitors. As a result, clinicians are seeking safer alternatives for T-cell modulation. Extensive research dollars and development efforts have been expended in search of a more selective and safer means of modulating T-cell function without triggering dangerous inflammatory responses or opportunistic infections; such as those seen in currently available therapies.
Product: Tolera has a clinically proven, T-cell specific, monoclonal antibody, ready for later stage trials (TOL101). It has been successfully manufactured and purified by several methods, and is currently being produced to GMP standards for further clinical investigation.
Target Market: The initial target market will be the solid organ transplant market where the MAb has proven clinical efficacy and superior safety in over 100 patients. The agent and its humanized versions have potentially attractive product profiles for the autoimmune and oncology markets where its anti-CD3 properties make it an ideal candidate for various T-cell mediated diseases. As a result, Tolera is poised to develop a deep pipeline, and address a number of valuable therapeutic opportunities.
Customers: Transplant surgeons, immunologists and oncologists who have experience with the MAb, have expressed strong interest in seeing it commercialized. These physicians are not satisfied with the current array of therapeutic agents and their untoward effects.
Business Model / Marketing Strategy: Develop safer, more targeted, T-cell therapy – TOL101. Obtain FDA market approval for first indication (solid organ transplant) within 3 years. Address the highly concentrated market of transplant practitioners with a safer, more targeted T-cell modulator. Parallel track development of T-cell therapies to address autoimmune and oncology applications to expand the pipeline (i.e. potential for partnering).
Competitive: While a number of T-cell antagonists have proven effective, they have created new clinical concerns over inflammation, opportunistic infections, and cancers resulting from their use. Tolera’s MAb profile offers the efficacy of the market leading agents with far lower risk of adverse events. Tolera intends to displace the antibody induction market leader (used off-label) once approved for transplant rejection. In autoimmune and oncology, there are no approved anti-CD3 T-cell mediators which combine strong efficacy with low risk of adverse event.
Tolera Therapeutics, Inc.