T1D-RAID Project Information
Project Name: IL-2/Fc-IL15/Fc fusion proteins components of the "Power Mix" immune modulator.Summary: This requestor presents a novel regimen consisting of two chimeric proteins generated by the fusion of two T cell growth factors (cytokines) bonded to the Fc portion of human immunoglobulin G (IgG-Fc). These chimeric proteins are an agonist IL-2 (IL-2/Fc) and a mutant antagonist of IL-15 (IL-15/Fc). The combination of these two proteins plus Rapamycin has been named "Power Mix" by Dr Terry Strom-who has demonstrated its capacity to induce and maintain a state of immune tolerance that prevents or halts/reverses the autoimmune process that leads to the destruction of the insulin producing beta cells of the pancreatic islets. The T1D-RAID program is working with Dr. Strom and his associates to develop the IL-2/Fc and IL-15/Fc fusion proteins and is assisting in the evaluation of manufacturing processes and production (including assays, purification, stability and quality control research studies) in addition to evaluating the pharmacokinetics, toxicology and efficacy of the regimen in animal models, with intent of conducting studies in humans.
Program Cycle: 3
Agent Category: Biologic
Investigator: Terry B. Strom, Beth Israel Deaconess Medical Center, Harvard University
Project Name: Purification of Lisofylline Drug Substance and Manufacture of Lisofylline Drug Product
Summary: Lisofylline (LSF) is a novel anti-inflammatory compound that has a unique spectrum of activity to improve beta cell function and viability by maintaining mitochondrial membrane potential and ATP production and reducing damage to islets by targeting IL-12 signaling and STAT4 phospholrylation. DiaKine is seeking to develop LSF for unmet medical needs in type 1 diabetes with a focus on preventing inflammatory damage to insulin producing cells in islets. T1D-RAID is supporting the manufacture of this substance and is working with DiaKine Therapeutics to acquire bulk drug, make GMP drug supplies for clinical studies, and conduct stability studies
Program Cycle: 2
Agent Category: Small Molecule
Investigator: Jerry Nadler, DiaKine Therapeutics, LLC
Project Name: Starch-Deferoxamine (S-DFO) for Diabetic Neuropathy
Summary: Biomedical Frontiers, Inc. (BMF) is developing innovative and proprietary iron-binding drugs for treatment of iron overload disorders and diabetic neuropathy. Specifically, BMF's patented technology involves conjugation of drugs to chemically modified polysaccharides, such as starch. The T1D-RAID program is supporting Biomedical Frontiers in the production of a S-DFO drug product and conduction of toxicology and stability testing, which will be used in support of a future IND submission.
Program Cycle: 2
Agent Category: Small Molecule-Polymer
Investigator: Bo Hedlund, Biomedical Frontiers, Inc.
Project Name: GMP Manufacturing of hOKT3γ1 (Ala-Ala) Monoclonal
Summary: The Bluestone project involves the development of humanized Fc receptor-non-binding anti-CD3 antibodies that, unlike their murine counterpart (OKT3) do not elicit a potentially toxic cytokine syndrome. Preliminary studies that hOKT3γ1 (Ala-Ala) may prevent the progression of Type 1 Diabetes in humans with new onset diabetes. The T1D-RAID program is assisting the UCSF Diabetes Center in the manufacture of the antibody in order to facilitate studies of an investigation as to the clinical efficacy of the drug in the treatment of type 1 diabetes.
Program Cycle: 1
Agent Category: Biologic
Investigator: Jeffery Bluestone, Tolerance Therapeutics, Inc.
T1D-RAID Projects
