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Tolera Therapeutics
Biotech Specialty Pharma
350 E. Michigan Avenue, Suite 205
Kalamazoo, MI 49007 USA
phone:(877) 986-5372
fax:(269) 585-2119
Symbol Private
Founded 2007
Employees
     www.tolerainc.com
Research Sector Biotech Specialty Pharma
Summary Description
T-Cell Antagonist for Treatment of Autoimmune Disorders, Transplant
Management
John J. Puisis, President and CEO; Maria Siemionow, MD, PhD, DSc, CSO; Jim Herrmann, Chief Operating Officer
Keywords
monoclonal antibody, immunology, transplant, T-cell therapy, TCR

Comment | Printable Version | Modify profile Dec. 21, 2009

Description
Tolera offers 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).
Products / Services
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.
Technology / Differentiation
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.
Market / Customers
The initial target market will be the solid organ transplant market where the MAb 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. Intended customers include: transplant surgeons, immunologists and oncologists, who have expressed strong interest in seeing the MAb commercialized. These physicians are not satisfied with the current array of therapeutic agents and their untoward effects.
Competitors / Substitutes / Alternatives
No other targeted anti-TCR drugs are approved, or under investigation for human therapeutic use.
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).
Funding
Currently venture funded, "Series A".
Status
Tolera was granted orphan drug status for its initial lead candidate in solid organ transplantation in April 2009. The company's product has been in previous human studies, and is ready for later stage trials and near-term market approval.