NOX-E36 (emapticap pegol) is a Spiegelmer* that binds and neutralizes the human chemokine CCL2, also referred to as MCP-1 (C-C Chemokine Ligand 2 / Monocyte Chemoattractant Protein 1), and the related chemokines CCL8, CCL11 and CCL13. NOXXON plans to position NOX-E36 in oncology since its target is implicated in cancer spread and immune privilege of tumors. The recent identification of a signature, called IPRES for Innate, PD-1 Resistance Signature, that appears to be linked to resistance to checkpoint inhibitors (Source: Bu et al. 2016) provides further rationale to use NOX-E36 in treating cancer. The IPRES contains a monocyte/macrophage component composed of four chemokines, three of which, CCL2, CCL8 and CCL13, are neutralized by NOX-E36.

NOX-E36 was originally developed in diabetic nephropathy where it completed a Phase 2a exploratory study which included 76 patients with Type 2 diabetes and proteinuria on top of standard of care. NOXXON believes promising results were obtained on two key parameters: protein in the urine as measured by the albumin to creatinine ratio (ACR), and glycated hemoglobin (HbA1c) in blood. Based on the results observed, NOXXON believes NOX-E36 may be the first disease-modifying drug for this indication. NOX-E36 was generally well tolerated in this study.

About the target
Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages. Both CCL2 and its receptor CCR2 have been demonstrated to be induced and involved in a variety of inflammatory diseases and are implicated in cancer spread and immune privilege of tumors.

Details of clinical studies available at clinicaltrials.gov
  • NOX-E36 First-in-Human (FIH) Study
    (Ref: NCT00976729)
    Status: completed
  • NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
    (Ref: NCT01085292)
    Status: completed, data analysis ongoing
  • NOX-E36 Renal Impairment Study
    (Ref: NCT01372124)
    Status: completed
  • NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
    (Ref: NCT01547897)
    Status: completed, data analysis ongoing
NOX-E36 publication archive
NOX-E36 press release archive

The press releases contained in this archive section are provided for historical purposes only. The information contained in each press release is accurate only as of the date each press release was originally issued. NOXXON disavows any obligation to update the information contained in such press releases after the date of their issuance.