ImmunoZyme's FucoTreg product is the next generation Regulatory T-cell product that overcomes current clinical challenges to improve Regulatory T-cell efficacy, reduces costs, and enables faster treatment with a lower cell dose requirement.
Phase 3 REgistration
Prevention of Kidney Organ
P3 Trial Planning
Type 1 Diabetes
University of Texas
Prevention of Graft Versus Host Disease
Severe Autoimmune Disease with Partners*:
Including MS, SLE, IBD, RA
ImmunoZyme: Fuco-Tregs that are Phase 2 and Phase 3 Trial Ready
Regulatory T-cell Therapies are potentially efficient and reliable therapeutic regimens to cure autoimmune disorders such as T1D and several life-threatening allergic reactions. However there are several technical constraints limiting their efficacy and commercial viability as curative treatments for auto-immune diseases today. These constraints include the inefficient trafficking of infused Regulatory T-cells to sites of auto-immune diseases (less than 3 percent of infused Regulatory T-cells reach sites of disease), their minimal residence time in auto-immune disease sites as well as the required high cell dose requirements resulting in its prohibitive costs and many weeks to patient therapy.
Targazyme’s FucoTreg product is the next generation Regulatory T-cell product which overcomes the above described technical constraints to improve Regulatory T-cell efficacy, reduce COGS and faster time to patient therapy with lower cell dose.
A Phase ½ pilot trial conducted by MD Anderson Cancer Center showed human safety and an early efficacy signal for the chronic GVHD end-point (a life-threatening ‘auto-immune disease’) for cancer patients undergoing for Stem Cell Transplantation. There were no patient cases with chronic GVHD receiving FuoTregs compared to the historical 50% - 60% incidence of chronic GVHD in patients undergoing stem cell transplantation.
Preclinical proof of concept data at MD Anderson demonstrated that FucoTregs infusion in GVHD animal models resulted in a 4 Fold increase in Regulatory T-cell trafficking to sites of auto-immune disease attack, increased Regulatory T-cell residence time in those sites and a 200 percent reduction in GVHD scores with 100 percent survival of animals receiving FucoTregs versus the 100 percent death rates of animals receiving non Targazyme Fuco-Tregs.
The clinical and preclinical efficacy outcomes observed for FucoTregs points to the potential of FucoTregs to improve on the current efficacy outcomes observed with Treg therapies today, not only to help prevent chronic GVHD in patients but also as potentially curative therapies for serious auto-immune disorders such as T1D and other life-threatening allergic reactions.