REGiMMUNE Initiates Phase I/II Clinical Trial for GvHD

TOKYO--(Marketwire - January 31, 2012) - REGiMMUNE Corporation said today that it has begun a Phase I/II study of its proprietary compound RGI-2001 for Graft versus Host Disease (GvHD) associated with hematopoietic stem cell transplantation. The safety and efficacy study will enroll approximately 50 bone marrow or peripheral blood stem cell transplantation leukemia patients following chemotherapy. The U.S.-based study will be conducted in five leading cancer centers including the Fred Hutchinson Cancer Research Center, Stanford University Medical Center, the Ohio State University Medical Center, University of California, San Diego and Massachusetts General Hospital/Harvard University.

RGI-2001 is a liposomal formulation of KRN7000, a synthetic derivative of alpha-galactosylceramide. The compound, which utilizes REGiMMUNE’s reVax technology, promotes transplantation tolerance by inducing regulatory T (Treg) cells. Treg has been shown to have significant potential for treating GvHD; in studies by independent researchers, Treg has proven to produce longer patient survival because it reduces rejection without reducing an anti-tumor graft versus leukemia (GvL) effect.

“The major problem with existing immunosuppressant therapy is the reduction of GvL,” explained Haru Morita, President and Chief Executive Officer of REGiMMUNE. “We hope to demonstrate, in our Phase I/II study, that by inducing Treg-mediated transplantation tolerance, RGI-2001 can be developed as an effective treatment to prevent graft rejection, without the risks associated with current therapies.”

$5 Million U.S. Financing Announced
REGiMMUNE also announced the closing of the first tranche of a Preferred A financing. The company raised $5 million U.S. in this tranche, which was led by Daiwa Enterprise Co. Ltd. and Japan Asia Investment Corporation (JAIC). Additionally, new investors Shinkin Capital Corporation and MediNet Co. Ltd. joined existing investor SMBC Venture Capital Co., Ltd., the VC arm of Sumitomo Mitsui Banking Corporation, in this round. Proceeds from this funding will be used primarily to support the company’s first clinical stage product development. The company is continuing to seek investors for a second tranche later this year.

About REGiMMUNE
REGiMMUNE is a biotechnology company focused on the discovery, development and commercialization of immune regulatory therapeutics to treat life-threatening and debilitating conditions, including allergies, autoimmune diseases and transplantation. The company’s proprietary platform technology, reVax, induces immune tolerance in an antigen-specific manner through pharmacological induction of regulatory T (Treg) cells. Using its reVax technology, REGiMMUNE is developing RGI-2001, which may be the first drug in the class of Treg-inducing agents.

The company is also applying its reVax technology to develop a range of pipeline products, including its RGI-1000 series for allergy and its RGI-3100 series for type 1 diabetes. Additionally REGiMMUNE is developing its RGI-4000 series for vaccine adjuvants. The company is seeking pharmaceutical partnership opportunities for its products worldwide, exclusive of Japan. REGiMMUNE is headquartered in Tokyo, Japan and has a U.S. operation in Santa Clara, California. For more information, visit www.regimmune.com.