Northway Biotech, a CDMO headquartered in Vilnius, Lithuania, and with a biomanufacturing facility in Waltham MA, signed an agreement with Sydney, Australia-based Immutep to manufacture IMP761 ahead of clinical testing. The product, Immutep’s preclinical candidate for autoimmune diseases, is an immunosuppressive agonist antibody to LAG-3. It has now been tested in a Th1-driven autoimmune disease setting, oligoarticular juvenile idiopathic arthritis, as a proof-of-concept.
Northway has already started developing a GMP-compliant manufacturing process of IMP761 and will manufacture IMP761 in large-scale bioreactors. The process is based on a pharmaceutical-grade, stable GS knockout CHO K1 cell line system that has been shown to produce product yields of IMP761 in small-scale setup. The work is undertaken at Northway’s Vilnius facility with the potential to expand the agreement to include further process scaleup and cover commercial supply in the future.
After completion of the required preclinical development, the material produced will be used for Immutep’s clinical trials of IMP761.
“As a targeted immunosuppressive antibody, IMP761 has the potential to address the root cause of autoimmune diseases by specifically silencing the autoimmune memory T cells accumulating at the disease site, known to express LAG-3,” says Marc Voigt, executive director, and CEO, Immutep.
“We are proud to be selected by Immutep as CDMO to support Immutep’s fight against autoimmune diseases which impair so many patients globally,” adds André Markmann, vp, business development, Northway Biotech.