KALAMAZOO — Tolera Therapeutics Inc., a privately held biotechnology company focusing on the development of immunotherapeutics to treat cancer, autoimmune diseases and the complications of transplants, said it had raised $5.5 million in a financing round it called Series B-3.

Hopen Life Science Ventures of Grand Rapids led the round and was joined by other current investors including Triathlon Medical Venture Partners and SWMF Life Science Fund.

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“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 with the United States Food and Drug Administration 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 or New Drug Application.

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Said Mark Olesnavage, managing director, Hopen Life Science Ventures and a member of the Tolera Board of Directors: “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.”

Tolera Therapeutics is a Kalamazoo-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.

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More at www.tolera.com.