Basel, Switzerland and Orsay, France, April 10, 2012 – Immutep and Lonza announced today an agreement for cell line selection, master cell banking and process development of ImmuFact(R) IMP321. Lonza will initiate the process development for Immutep’s lead product, using Immutep's newly-developed proprietary cell lines. Immutep announced Phase I/II results for IMP321 in an oral presentation at ASCO (American Society of Clinical Oncology conference) in 2010 describing its use in a chemo-immunotherapy protocol in first-line metastatic breast cancer.
“We are pleased to support Immutep’s development initiatives,” said Janet White, head of Lonza development services. “This partnership directly reflects Lonza’s commitment to emerging biotechnology innovation through its clinical milestones.”
IMP321 (LAG-3Ig) has potential for the treatment of advanced cancer in combination with standard first-line chemotherapy. IMP321 is an antigen presenting cell (APC) activator. Tumour-specific memory CD8 T cells are activated by these APC and contribute to tumour regression.
“We have every confidence in Lonza to carry out the production for pivotal trials and beyond,” said Dr. Frederic Triebel, scientific and medical director of Immutep. “The mechanism of action of this synergistic combination of chemotherapy and active immunotherapy is very simple. The chemotherapy provides a burst of tumour cell debris and the surrounding APC take up the tumour antigens. IMP321 activates these APC resulting in a long-lasting CD8 T cell response against the tumour. We think that the combination of first-line standard chemotherapy plus IMP321 should be tested in several first-line indications. We are in partnering discussions at present.”
About ImmuFact(R) IMP321
IMP321 is an APC (antigen presenting cell) activator that 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. In addition, the APC activation observed in the blood was dose-dependent and correlated with the reduction of the tumour mass. IMP321 is a LAG-3Ig fusion protein produced in CHO (Chinese Hamster Ovary) cells.
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 chemoimmunotherapy is to amplify natural pre-existing T cell responses specific for any known or unknown tumour antigen and to recruit and amplify new tumour-specific T cell responses resulting from the use of cytotoxic drugs. The direct cytolytic effect of some cytotoxic drugs, such as paclitaxel, can enhance antigen loading of APC by inducing tumour cell apoptosis.
Clinical Development History
More than 600 subcutaneous injections of IMP321 have been administered to date 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:
- ImmuTune(R) IMP701
IMP701 is an antagonist anti-LAG-3 antibody. It gives rise to T cell proliferation in a similar manner to anti-CTLA-4 and anti-PD-1 antibodies except that it also inhibits T regulatory cells (Tregs) giving it a unique double mode of action. Partnering discussions are in progress.
- ImmuTune(R) IMP731
IMP731 is a depleting anti-LAG-3 antibody for autoimmune disease. This product is licensed to GSK.
For more information, visit http://www.immutep.com
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations and delisting. In 2011, the company had sales of CHF 2.69 billion.
Further information can be found at http://www.lonza.com