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GMP Manufacturing Process Developed for Immutep’s IMP761

Achievement allows IND-enabling studies in 1H 2023 and subsequent clinical testing of IMP761 to address root cause of autoimmune diseases.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, announced today that a GMP compliant manufacturing process has been established for IMP761, its proprietary preclinical candidate for autoimmune diseases.
 
The 200L scale attained by Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organization (CDMO), will ensure supply of IMP761 for IND-enabling studies and ensuing clinical trials.
 
An immunosuppressive agonist antibody to LAG-3 acting upstream on activated T cells to target the root cause of self-antigen-specific T cell induced disease, IMP761 is a potential game-changer in how autoimmune diseases are treated. Pre-clinical testing of IMP761 in oligoarticular juvenile idiopathic arthritis, published in Pediatric Research in May 2021, showed that agonistic activation of LAG-3 in this Th1-driven autoimmune disease setting resulted in a decreased secretion of nearly all measured cytokines, and that of IL-10, IL-12, IL-1beta, IL-4, and IL-6 reached the level of significance (p is less than 0.01).
 
Immutep CEO Marc Voigt said: “We are pleased to have a GMP manufacturing process for IMP761 in hand with our manufacturing partner Northway Biotech as we move towards initiating IND-enabling studies in the first half of 2023 and subsequent clinical development. As a first-in-class LAG-3 immunosuppressive antibody, IMP761 has been designed to address the root cause of autoimmune diseases by specifically silencing self-reactive exhausted effector T cells that express LAG-3 and accumulate at disease sites.”
 
Vladas Algirdas Bumelis, CEO of Northway Biotech stated: “Our world-class team in Vilnius worked diligently and expeditiously to develop the capability to produce this unique LAG-3 antibody at 200L scale. We continue to work closely with Immutep to accelerate the development of its first-in-class LAG-3 therapy and help advance this novel approach against autoimmune diseases that impair so many patients on a global basis.”
 
The manufacturing process was developed on a platform technology of Northway Biotech resulting in a final product of high quality. An engineering and a GMP manufacturing run at 200L have been successfully performed for bulk drug substance and final filled drug product, proving the robustness and reproducibility of the developed manufacturing process. A stability program according to ICH guidelines has been initiated and will support the definition of a shelf life of the drug in its current formulation. After final release and batch certification, the produced material will be used for further preclinical development, including IND-enabling studies, and Immutep’s planned clinical trials of IMP761.

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