Benzinga | Dec 16, 2021 08:32AM EST

Immutep Says Advances IMP761 Manufacturing

Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has signed a Manufacturing Service Agreement (MSA) with Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of clinical testing.



IMP761, 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 which has been published in the peer-reviewed Pediatric Journal in Oct 2021.1

Northway Biotech is a European specialist manufacturer of recombinant proteins and monoclonal antibodies, with manufacturing sites in Lithuania and the United States. Under the agreement, 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, Lithuania facility with the potential to expand the agreement to include further process scale up 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. Planning for further pre-clinical and clinical development is ongoing.

Commenting on the agreement, 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."

Vladas Algirdas Bumelis, CEO of Northway Biotech 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."

Andr? Markmann, VP Business Development of Northway Biotech, added: "We are proud to be selected by Immutep as CDMO to support Immutep?s fight against autoimmune diseases which impair so many patients globally."