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350 E. Michigan Avenue, Suite 205
Kalamazoo, MI 49007 USA
phone:(877) 986-5372
fax:(269) 585-2119 |
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Private |
| Founded |
2007 |
| Employees |
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| www.tolerainc.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| T-Cell Antagonist for Treatment of Autoimmune Disorders, Transplant |
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| Management |
| John J. Puisis, President and CEO; Maria Siemionow, MD, PhD, DSc, CSO; Jim Herrmann, Chief Operating Officer |
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| Keywords |
| monoclonal antibody, immunology, transplant, T-cell therapy, TCR |
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| Description |
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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). |
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| 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.
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| 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. |
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| 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.
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| Competitors / Substitutes / Alternatives |
No other targeted anti-TCR drugs are approved, or under investigation for human therapeutic use.
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| 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).
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| Funding |
| Currently venture funded, "Series A". |
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| 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. |
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