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This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.
On April 15, 2020, Immutep, an Australian biotechnology company specializing in lymphocyte activation gene-3 (LAG-3)-related immunotherapeutic products, and Batavia Biosciences, a Leiden, the Netherlands-based contract development and manufacturing organization, announced the successful generation of a high-yielding cell line for an immunoglobulin 4 (IgG4)-based antibody for LAG-3 immunotherapy for autoimmune diseases. The antibody, known as IMP761, represents an important milestone in the preclinical development of the compound. The companies can now move forward with development of a GMP-compliant manufacturing process and aim to initiate clinical testing of the compound as soon as possible.
LAG-3 is a protein that 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. This makes the LAG-3 protein a promising focus for the development of novel cancer or autoimmune disease therapies, according to the companies.
The pharmaceutical-grade, stable Chinese hamster ovary (CHO) cell clones that have been developed provide significantly higher product yields of Immutep’s IMP761 product candidate than initially anticipated. The 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, the companies report in a press release.
In September 2019, Batavia announced licensing of Horizon Discovery’s GS-knockout CHO expression system, CHOSOURCE, which enables the rapid generation of clones expressing high levels of monoclonal antibody (mAb) during the development of a stable production cell line.
“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,” said Batavia Biosciences’ CEO, Menzo Havenga PhD, in the press release.
“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,” added Immutep CEO Marc Voigt in the press release.
Source: Batavia Biosciences