Immunotherapy development company Immutep (ASX:IMM) has signed a Manufacturing Service Agreement with Northway Biotech.
Immutep is developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases.
Northway Biotech is an end-to-end biopharmaceutical contract development and manufacturing organisation that will produce Immutep's IMP761 ahead of clinical testing.
IMP761 is Immutep’s preclinical candidate for autoimmune diseases. It is an immunosuppressive agonist antibody to LAG-3 that has now been tested in a Th1-driven autoimmune disease setting, oligoarticular juvenile idiopathic arthritis, as a proof of concept.
Northway Biotech is a European specialist manufacturer of recombinant proteins and monoclonal antibodies. It has manufacturing sites in Lithuania and the US.
Under the agreement, Northway has already started developing a GMP-compliant manufacturing process of IMP761 and will manufacture it 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 facility in Vilnius, Lithuania, with the potential to expand the agreement to include further process scale-up and cover commercial supply in the future.
Immutep CEO Marc Voigt said, “We are very excited to be partnering with Northway Biotech to develop a GMP manufacturing process for 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. We are very pleased to be moving IMP761 towards clinical trials.”
The CEO of Northway Biotech Vladas Algirdas Bumelis said, “We have a long and successful history of developing processes to facilitate efficient and scalable production for new and promising products. Our team in Vilnius is looking forward to applying their world-class skills and state-of-the-art equipment to develop a manufacturing process including GMP manufacturing for Immutep’s IMP761.”