Tolera Therapeutics closes Series B-3 financing, raises $5.5 million to submit Phase 3 Special Protocol Assessment for its immune targeting biologic drug in kidney transplantation

KALAMAZOO, Mich., Oct. 16, 2012 — /PRNewswire/ – Tolera Therapeutics Inc., a privately held biotechnology company focusing on the development of immunotherapeutics directed at the transplantation, autoimmune and oncology markets, announced today that it has closed its Series B-3 financing.  Hopen Life Science Ventures of Grand Rapids, Michigan led the round and was joined by other current investors including Triathlon Medical Venture Partners and SWMF Life Science Fund.

“This funding provides support to close out Phase 2 activities and preparation for Phase 3 investigation of TOL101, our lead clinical candidate,” said CEO John Puisis.  “We are excited to bring this novel T-cell targeting biologic drug to market where there is a significant need for new immune modulating strategies and few, if any, industry pipeline alternatives.”

Tolera is planning to submit a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial comparing TOL101 to Thymoglobulin, the current market leading induction agent, for prevention of acute organ rejection.  The FDA Special Protocol Assessment process allows sponsors to seek FDA acceptance of a Phase 3 protocol design, prior to conducting a study to support efficacy claims to be submitted as part of a Biologics Licensing Application (BLA) or New Drug Application (NDA).

Mark Olesnavage, managing director, Hopen Life Science Ventures and a member of the Tolera Board of Directors added:  “We are pleased to lead this funding round for Tolera, a company with promising technology and a nearer-term market opportunity.  Our Phase 2 data has demonstrated key advantages in transplantation, and we look forward to the Phase 3 investigation and ultimate market approval of this novel immune targeting agent.”

CEO Puisis continued, “We are pleased by the continuing support of our investors as well as the clinical investigators we have been working with, who continue to confirm the significant unmet need for an alternative induction agent.”

About Tolera Therapeutics:  Tolera Therapeutics is a Kalamazoo, Michigan based biotechnology company focusing on commercializing its therapeutic monoclonal antibody technology for the transplantation market.  Building upon research done at the University of Kentucky and the Cleveland Clinic, Tolera Therapeutics is developing and commercializing therapies for immune modulation with the goal of addressing unmet medical needs with safer, more targeted solutions to reduce the risk of serious and toxic side effects often associated with immunotherapy.  Primary investors in the company include Triathlon Medical Venture Partners, Hopen Life Science Ventures, the SWMF Life Science Fund, and the Michigan Economic Development Corporation. Additional information concerning the company and its technology can be found on its website

SOURCE Tolera Therapeutics