4/8/2014 1:36:01 PM
WuXi AppTec will manufacture ImmuFact(R) IMP321 to US, European and Chinese GMP standards for Immutep and Eddingpharm
Orsay, France and Shanghai, China, 8 April 2014 – 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.”
About ImmuFact(R) IMP321
IMP321, a LAG-3Ig fusion protein, has completed a Phase I/II clinical trial combined with chemotherapy (chemo-immunotherapy) in first-line metastatic breast cancer. The trial showed that 90 per cent of the 30 patients experienced clinical benefit at six months. The APC activation observed in the blood was dose-dependent and correlated with the reduction of the tumor mass.
• APC Activators
Antigen presenting cell (APC) activators induce the activation, maturation and migration of antigen presenting cells like dendritic cells. This gives rise to improved antigen presentation to T cells and enhanced T cell responses against tumours.
• AIPAC TRIAL
Immutep has started planning the AIPAC (Active Immunotherapy - PAClitaxel) Phase IIb/III clinical trial in first line metastatic breast cancer, following scientific advice from the EMA. Other trials in other cancers and with other chemotherapies will follow to expand the use of IMP321 in chemo-immunotherapy.
The objective of chemo-immunotherapy is to amplify natural pre-existing T cell responses specific for known and unknown tumor antigens and to recruit and amplify new tumor-specific T cell responses resulting from the use of cytotoxic drugs. The direct cytolytic effect of some cytotoxic drugs enhance antigen loading of APC by inducing tumor cell apoptosis.
• Clinical Development History
More than 600 subcutaneous injections of IMP321 have been administered in Europe and the USA, at doses up to 30 mg with no clinically significant drug-related adverse events. A Phase I trial in metastatic renal cell carcinoma with IMP321 alone and a Phase I/II trial in metastatic breast cancer combining IMP321 with paclitaxel in a chemo-immunotherapy protocol have been completed. Four Phase I/II clinical trials are in progress using IMP321 as adjuvant in cancer vaccines in disease-free melanoma, metastatic melanoma treated by lympho-depletive/adoptive transfer, metastatic melanoma and prostate cancer.
About Immutep S.A.
Immutep S.A. is a biopharmaceutical company developing immunostimulatory factors for the treatment of cancer and immunomodulatory therapeutic antibodies for the treatment of cancer or autoimmune disease. The company's technologies are based on the LAG-3 immune control mechanism that mediates T cell immune responses. LAG-3 (CD223) is Lymphocyte-Activation Gene-3. Apart from IMP321, described above, two of the company's other products are:
IMP701 is an antagonist anti-LAG-3 antibody. It is an immune checkpoint inhibitor like the anti-CTLA-4 and anti-PD-1 antibodies. This product is licensed to Novartis.
IMP731 is a depleting anti-LAG-3 antibody for autoimmune disease, licensed to GSK.
For more information, visit http://www.immutep.com.
Founded in 2001, Eddingpharm is a fast-growing specialty pharmaceutical company in the Chinese market, committed to actively introducing quality products into China's pharmaceutical market. The Company focuses on the development and promotion of pharmaceutical products in four therapeutic areas: clinical nutrition, oncology, antibiotics and respiratory system. Eddingpharm has established long-term cooperative relationships with a number of multinational pharmaceutical companies and overseas specialty pharmaceutical companies and has built up a competitive product portfolio and pipeline in the four major therapeutic areas. Eddingpharm recently established its US affiliate and set up a product development team with R&D capabilities in Los Angeles, CA, USA, to coordinate and communicate with leading global R&D institutions and explore opportunities for introducing innovative pharmaceutical products in China. The Company currently employs over 700 people. More information can be found on http://www.eddingpharm.com.
About WuXi AppTec
The operating subsidiaries of WuXi PharmaTech are known as WuXi AppTec. WuXi PharmaTech (NYSE: WX) is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical, biotechnology and medical device companies with a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to help its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. For more information, visit http://www.wuxiapptec.com.
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