10 November 2017 - - US-based ImmunoMolecular Therapeutics (IM Therapeutics), a company developing personalized small molecule therapies for the treatment of genetically defined autoimmune diseases, has made its debut as a spinout from the Barbara Davis Center for Diabetes at the University of Colorado, the company said.

IM Therapeutics was co-founded by Peter Gottlieb, M.D., Professor of Pediatrics and Medicine with tenure at the University of Colorado Health Science Center, and director of Translational Research Unit at the Barbara Davis Center for Diabetes; and Aaron Michels, M.D., Associate Professor of Pediatrics and Medicine at the University of Colorado Denver, the Frieda and George S. Eisenbarth Clinical Immunology Endowed chair, and director of Clinical Immunology at the Barbara Davis Center for Diabetes.

The company was created to advance new therapeutic strategies for Type 1 Diabetes that aim to directly inactivate pathogenic immune cells responsible for damaging the insulin-producing beta cells in the pancreas.

The key to this approach is the group of immune molecules called human leukocyte antigens.

Because HLA molecules arise from genes that are slightly different among individuals (i.e., alleles), some HLA alleles function in an abnormal way to "mis-present" autoantigens that leads the body to mount an immune system attack against itself.

The HLA-DQ8 allele is one such gene known to predispose individuals that carry it for T1D by mis-presenting autoantigens that favor the generation and function of harmful, but not protective, immune cells.

IM Therapeutics' scientific co-founders discovered that an oral small molecule drug, methyldopa, targets and inhibits the HLA-DQ8 molecule. The company's lead candidate, IMT-002, is a proprietary formulation of the D enantiomer of methyldopa.

The D enantiomer offers more convenient dosing, better potency and less side effects than the L enantiomer which is an anti-hypertensive. The company has received orphan designation for methyldopa, which applies to both enantiomers.

IMT-002 is currently in preclinical development as a candidate to treat T1D in patients with the HLA-DQ8 gene. Gottlieb and Michels will continue to advance the development of autoimmune therapies for IM Therapeutics as Chief Medical officer and chief scientific officer, respectively, while maintaining their clinical and academic appointments.

The company will be led by Dr. Orndorff as president and chief executive officer and Greg Kading, CFA as chief financial officer and chief operating officer.

Orndorff and Kading previously worked together at Accera, where they were instrumental in guiding the company from R and D to commercialisation.

IMT-002 (D-methyldopa) is an oral small molecule drug being developed to treat T1D in patients with the HLA-DQ8 gene. IMT-002 occupies the peptide binding groove of DQ8 present on the surface of antigen presenting cells where diabetogenic peptides such as insulin are presented to CD4 T-lymphocytes to initiate the autoimmune cascade.

When HLA-DQ8 function is inhibited, the immune system will no longer attack insulin producing beta-cells, thus creating the potential for at risk or early stage patients to maintain normal insulin production.

IM Therapeutics is developing personalised immuno-therapeutic drugs for autoimmune diseases based on the genetic risk attributed by human leukocyte antigen genes.

The lead candidate drug is an oral small molecule that starves the autoimmune process in type 1 diabetes by blocking DQ8 on specific immune cells. The company's goal is to preserve pancreatic beta cell function and maintain normal insulin production in at-risk and early-stage patients with type 1 diabetes.