WuXi AppTec will manufacture ImmuFact(R) IMP321 to US, European and Chinese GMP standards for Immutep and Eddingpharm
Immutep S.A., the biopharmaceutical company specializing in immuno-oncology, and Eddingpharm have started production of Immutep’s ImmuFact(R) IMP321 (a LAG-3Ig fusion protein) at WuXi AppTec facilities in China. The product is being produced to European, U.S. and Chinese GMP standards.
WuXi AppTec has initiated process development for Immutep’s lead product using Immutep's newly developed proprietary cell line. Immutep is additionally providing full technical support for the development of the production. Immutep and Eddingpharm will develop the product in combination with first-line chemotherapy in metastatic cancer.
Like the checkpoint inhibitors that remove the brake on the CD8 T cells and greatly extend survival in metastatic cancer, antigen presenting cell (APC) activators also increase the T cell response against tumors. ImmuFact(R) IMP321 (a first-in-class APC activator) can be used in combination with first-line chemotherapy or in combination with checkpoint inhibitors.
The mechanism of action of Immutep’s synergistic combination of chemotherapy and active immunotherapy is unique. Chemotherapy provides a burst of tumor cell debris, and the surrounding APCs take up the tumor antigens. ImmuFact(R) IMP321 activates these APC’s, resulting in a long-lasting CD8 T cell response against the tumor.
"We have been very impressed by WuXi's know how and motivation,” said Dr. Frederic Triebel, Scientific and Medical Director of Immutep. “This deal is important for Immutep to continue the development of APC activators in the expanding field of immuno-oncology, in Europe, the USA and Japan. We are in partnering discussions at present.”
“Eddingpharm is excited to be entering the new field of immuno-oncology with Immutep. We believe that immuno-oncology will revolutionize cancer treatment," said Xin Ni, Chairman and CEO of Eddingpharm. "We are working closely with Immutep to develop IMP321.”
“Manufacturing IMP321, a first-in-class biologics in China, showcases WuXi’s solid capability as the gateway for developing novel biologics in China with global standards,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “Once manufacturing is complete, we will achieve the first industry milestone of using the same CMC package, developed at WuXi, for global registration in US, Europe and China.”