Leiden, April 15, 2020 – Immutep and Batavia Biosciences announce today that they have successfully generated a high yielding cell line for an IgG4-based antibody for LAG-3 immunotherapy for autoimmune diseases, known as IMP761, reaching an important milestone in the preclinical development of the compound. This achievement triggers a green light to move forward with development of a GMP-compliant manufacturing process with the aim of initiating clinical testing of this promising and potentially life-saving treatment as soon as possible.
LAG-3 stands for Lymphocyte Activation Gene-3, a protein, which is involved in the regulation of the immune system. It was discovered in 1990 by Immutep’s Chief Scientist and Medical Officer, Professor Frederic Triebel. The LAG-3 protein controls the signaling between specific immune cells, T cells and antigen presenting cells (APCs), which are responsible for the adaptive immune response, making it a very promising focus of novel cancer or autoimmune disease therapies.
The pharmaceutical-grade, stable CHO cell clones developed provide significantly higher product yields of Immutep’s IMP761 product candidate than initially anticipated. The outstanding project results permit a smooth transition to the next development stages. The fact that the product candidate is an IgG4-based biopharmaceutical, which is less commonly used in the field, demonstrates that the manufacturing platform is versatile and suitable for a broad range of monoclonal antibody therapeutics.
In September 2019, Batavia announced licensing of Horizon Discovery’s GS-knockout CHO expression system, CHOSOURCE™. The full services package using this system, including cell line generation, process development and manufacturing, is marketed by Batavia as STEP®-mAb. The CHO-GS expression system is the industry’s standard to achieve high product yields. Furthermore, it enables the rapid generation of clones expressing high levels of monoclonal antibody during the development of a stable production cell line.
Batavia Biosciences’ CEO, Menzo Havenga Ph.D., states: “We are pleased that STEP®-mAb proves its value in the development of this important LAG-3 immunotherapy product and it demonstrates that Batavia has been successful in transferring the CHOSOURCE™ technology to its facilities.”
Immutep CEO, Marc Voigt said: “IMP761 is the first agonist antibody that targets the immune checkpoint LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis. We are really pleased with the results generated by Batavia and are excited to be moving closer to clinical testing of this promising product candidate.”
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Further information can be found on the Company’s website www.immutep.com.
About Batavia Biosciences
Batavia Biosciences significantly contributes to ease human suffering from infectious diseases and cancer by improving the success rate in the translation of candidate medicines from discovery to the clinic. We offer our innovative technologies and in-depth know-how in order to help our partners to complete preclinical phases in biopharmaceutical product development at higher speed, reduced costs and increased success. The company focuses on the early stages of product development including cell line generation, upstream process development, purification development, product characterization and clinical manufacturing. Headquartered in Leiden, the Netherlands, with a subsidiary in Woburn, Massachusetts, and offices in Hong Kong, Batavia Biosciences is privileged to have strong strategic partners worldwide.