IRX4204

  • IRX4204 is a potent, and highly selective RXR agonist with demonstrated safety and anti-cancer activities, anti-neurodegenerative disease activities, and anti-autoimmune disease activities in preclinical and phases I and II clinical studies.
  • 100 patients have been treated with IRX4204, including 85 with various cancers and 15 with early-stage Parkinson’s disease under US INDs.
  • IRX4204 has been safe and well tolerated with up to 20 months of treatment in humans.
  • Oral PK in humans is consistent with once per day dosing.
  • Common side effects include dose related suppression of TSH with resultant hypothyroidism, mild to moderate increased triglycerides, and transient mild to moderate reversible leukopenia.
  • Open label phase I and IIA clinical trials in cancers and Parkinson’s disease support clinical safety and efficacy.
  • Preclinical data demonstrate synergy of therapeutic effects of IRX4204 plus anti-Her2 mab trastuzumab; HER2 tyrosine kinase inhibitors; or paclitaxel in HER2+ breast cancer.
  • Preclinical data demonstrate therapeutic activity on trastuzumab resistant, and HER2 tyrosine kinase resistant HER2+ breast cancers.
  • IRX4204 has been shown to be brain penetrant, with potential use in the treatment of brain metastasis in HER2+ breast cancer.
  • IRX4204 promotes Treg differentiation, inhibit Th17 differentiation, and inhibits IL-17, TNF, and IL-6 production.
  • IRX4204 is effective in animal models of Parkinson’s disease, Alzheimer’s disease, autoimmune encephalomyelitis, dopaminergic and cortical neuron survival and functions, insulin sensitization of cortical neurons, cortical neuron neurite outgrowth, oligodendrocyte differentiation, demyelination, remyelination, and graft versus host disease.