On May 6, 2008 REGiMMUNE Corporation, a privately held biopharmaceutical company, reported that it has closed its Series B financing for a total of $8 million U.S. Proceeds from the financing will be used to advance the company’s lead program, RGI-2001, to human clinical trials for graft versus host disease (GvHD) (Press release, REGimmune, MAY 6, 2008, View Source [SID1234642239]). Preclinical development for GvHD associated with bone marrow transplantation has been completed and an Investigation New Drug application is expected to be filed in late 2008.
"This financing underscores our ability to make significant progress towards the clinic and eventual product commercialization," commented Haru Morita, President and Chief Executive Officer of REGiMMUNE. "To thrive as REGiMMUNE has, in a very difficult business environment for many biotech companies in Japan, is a particularly great achievement."
New and existing investors include NIF SMBC Ventures Co., Ltd.; CSK Venture Capital Co., Ltd.; Japan Asia Investment Co., Ltd. and Yasuda Enterprise Development Co., Ltd.
The company’s proprietary technology platform, MultiVax, induces antigen-specific immune tolerance via induction of Tregs, a T-cell subset that plays a central role in controlling immune responses to self-antigens and pathogens when administered at the time of exposure to disease-causing antigens. Because of its specificity in targeting immune suppression, MultiVax is anticipated to exhibit higher efficacies with more favorable safety profiles over current immunomodulatory drugs.
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RGI-2001 for GvHD
REGiMMUNE plans to start development of its MultiVax product RGI-2001 to treat GvHD following allogeneic stem cell transplantation (SCT) primarily for bone marrow transplants. A major clinical challenge associated with allogeneic SCT is to maintain a fine balance of the immune system to prevent GvHD, serious infection, and/or recurrence of malignancy. This balance is critical because intensive immune suppression will result in infection and recurrence of malignancy while insufficient immune suppression may cause GvHD.
Serious GvHD occurs in up to 40% of HLA-matched allogeneic SCT cases, and 100% in haploidentical, related allogeneic SCT. Current treatment is prophylactic use of immunosuppressants such as cyclosporine A. High-dose steroids are administered once GvHD occurs but the condition often progresses to steroid refractory status and there is no proven second-line therapy for steroid refractory GvHD. Prevention and treatment of GvHD thus represent high unmet medical needs addressing serious, life-threatening conditions. If alloantigen specific, selective immune suppression can be induced with RGI-2001, it would be possible to suppress GvHD while maintaining protective immune responses to infection and recurrence of malignancy.