October 22, 2014 6:44 PM ET

Biotechnology

Company Overview of REGiMMUNE Corporation

Company Overview

REGiMMUNE Corporation, a biotechnology company, engages in the discovery, development, and commercialization of immune-regulatory therapeutics to treat life-threatening diseases and debilitating disorders. Its products include RGI-2001 for graft versus host disease (GvHD) associated with hematopoietic stem cell transplantation (HSCT) as a proof of concept; and RGI-3010, a immunetolenance inducing liposome encapsulating proinsulin designed to increase the number of regulatory T cells and tolerize the immune system to proinsulin, thereby turning off the self directed immune attack. The company was founded in 2006 and is headquartered in Tokyo, Japan. It has an additional office in Mountain Vie...

1-7-8 Kaigan

Tokyo Industry Trade Center 607 (6th Floor)

Minato-ku

Tokyo,  105-0022

Japan

Founded in 2006

Phone:

81 3 6809 2199

Key Executives for REGiMMUNE Corporation

Co-Founder
Chief Development Officer and Senior Director
Compensation as of Fiscal Year 2014.

REGiMMUNE Corporation Key Developments

REGiMMUNE Corporation to Present Its Method for Long-Term Tolerance in Organ Transplantation at World Transplant Congress in San Francisco

REGiMMUNE Corporation announced that it will present results from its research on its novel approach to long-term tolerance in organ transplantation without continuous administration of immune suppressants at the World Transplant Congress (WTC) on Tuesday, July 29, 2014. Robust, lifelong, donor-specific tolerance can be reliably achieved by induction of mixed chimerism in various animal models of bone transplantation. To date, the clinical application of these protocols has been impeded by the potential toxicity of the required host conditioning regimens. The REGiMMUNE poster presents the potential of a novel approach using a ligand alpha-GalCer (aGC) for iNKT cells and suboptimal dosage of antibody that blocks CD40:CD40L signaling as a powerful method to generate mixed chimerism. Invariant natural killer T (iNKT) cells are one of the innate lymphocytes that regulate immunity, although it is still elusive how iNKT cells should be manipulated for transplant tolerance. It previously reported that the liposomal formulation of -galactosylceramide (Lipo-aGC) could enhance immune-regulative aspect of iNKT cells compared to the conventional aGC. Here describe a novel approach to induce mixed chimerism (MC) by activating iNKT cells with Lipo-aGC under CD40-CD40L blockade (MR1). 3Gy irradiated BALB/c mice were transplanted with B6 bone marrow cells (BMC s) with/without Lipo-aGC and/or several dosages of MR1. Only combination therapy of Lipo-aGC plus suboptimal-MR1 showed robust MC. Mice established MC completely accepted subsequent cardiac allografts in a donor-specific manner. High amounts of Th2-cytokines were detected right after iNKT-cell activation, while subsequent IFN- production by NK cells was effectively inhibited by MR1. Expansion of regulatory T cells (Tregs) was observed in MC mice and Treg-depletion on 1 day before transplantation resulted MC brake. Further, iNKT-cell knockout mice failed both MC establishment and Tregs expansion. These results collectively suggest that new protocol makes it possible to induce donor-specific tolerance by enhancement of the innate regulatory mechanism in place of the conventional immunosuppression.

REGiMMUNE Corporation Presents at The 21st Annual Future Leaders in the Biotech Industry Conference, Mar-28-2014 03:30 PM

REGiMMUNE Corporation Presents at The 21st Annual Future Leaders in the Biotech Industry Conference, Mar-28-2014 03:30 PM. Venue: Millennium Broadway Hotel & Conference Center, New York, New York, United States.

REGiMMUNE Corporation Begins Enrollment for Phase II Clinical Trial for Graft Versus Host Disease

REGiMMUNE Corporation announced that it has begun a Phase II study of its proprietary compound RGI-2001 for GvHD associated with hematopoietic stem cell transplantation. The multicenter study is being conducted in six highly regarded US cancer centers including the Fred Hutchinson Cancer Research Center, Stanford University Medical Center, the Ohio State University Medical Center, University of California, San Diego, Massachusetts General Hospital/Harvard University and University of Miami Sylvester Comprehensive Cancer Center. The study was initiated following the successful completion of a Phase I study in patients with bone marrow or peripheral blood stem cell transplantation leukemia patients following chemotherapy. The RGI-2001 study is a randomized, open-label, multicenter Phase II study being conducted in patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT). This clinical trial is the expansion of the company's Phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The expansion phase will further evaluate the pharmacologic effects of either a maximum tolerated dose, maximum feasible dose or optimal pharmacologically active dose of RGI-2001. This Phase II study will expand the enrollment criteria from Phase I and allow transplantation by either related or unrelated donors. This study is designed to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity. Results from the Phase I study demonstrated very clean safety profile with no safety concerns observed up to the highest cohort. 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.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
February 14, 2014
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