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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 7
www.tolera.com
Research Sector Biotech Specialty Pharma
Summary Description
T-Cell Modulation 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
Phase 2, monoclonal antibody, immunology, transplant, T-cell therapy, TCR, induction, autoimmune, diabetes, multiple sclerosis, Oncology

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Updated: Sept. 20, 2011

Description
Tolera offers a highly specific T-cell targeting 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, MS) and hematological malignancies (e.g. pediatric ALL). The company's anti-body serves as a safe T-cell antagonist, which inhibits the onset of the body's immune system response in a highly efficient manner. Current T-cell antagonists operate as either overly broad spectrum, toxic agents, or as overly specific and less effective immune inhibitors, giving Tolera's therapy an edge as a safe and effective alternative.
Products / Services
Tolera has a clinically proven, T-cell specific, monoclonal antibody, in Phase 2 trials (TOL101). It has been successfully manufactured and purified to GMP standards for clinical investigation and commercialization.
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 an attractive product profile for T-cell modulation. Other potential indications to be investigated include 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. Physicians are not satisfied with the current array of therapeutic agents, their untoward effects and narrow therapeutic indices.
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. Partner with a collaborator to parallel track development of T-cell therapies to address autoimmune and oncology applications to expand the pipeline.
Funding
Currently venture funded, "Series B". A follow-on investment opportunity is currently open (Dec 2010 - March 2011) for opportunistic investment.
Status
Tolera was granted orphan drug status for solid organ transplantation in April 2009 and for type 1 diabetes in 2010. The company's product has been in previous human studies, and is ready for later stage trials and near-term market approval.