Immutep and Eddingpharm sign agreement for development of ImmuFact® IMP321 in China

Eddingpharm has exclusive rights to develop and market ImmuFact® IMP321 in mainland China, Hong Kong, Macau and Taiwan

Orsay, France, October 7 2013 – Immutep S.A., the biopharmaceutical company specializing in immuno-oncology, and Eddingpharm have entered into an agreement regarding the development, commercialization and manufacturing of Immutep’s ImmuFact® IMP321. Financial details are undisclosed but include milestone payments and royalties. Burrill Securities acted as financial advisor on this transaction.

The agreement grants Eddingpharm exclusive rights to develop and market IMP321 in mainland China, Hong Kong, Macau and Taiwan. Immutep will provide full technical support for the development of the product. Immutep and Eddingpharm plan to develop the product for first-line metastatic breast cancer as well as other first-line metastatic indications.

Like the checkpoint inhibitors that induce tumor regression and extend survival, antigen presenting cell (APC) activators increase the T cell response against tumors by a different but complementary mechanism, which enhances antigen presentation to T cells. IMP321 (a first-in-class APC activator) can be used in combination with first-line chemotherapy or in combination with checkpoint inhibitors.

"We have been very impressed by the dynamic and innovative approach of Eddingpharm, and believe them to have the capability of driving the development of IMP321 in China,” said John Hawken, CEO. “Immutep is continuing the development of IMP321 in Europe and the USA. We are in partnering discussions at present.”

“We are excited to be entering the new field of immuno-oncology. We believe that immuno-oncology will revolutionize cancer treatment," said Xin Ni, chairman and chief executive officer of Eddingpharm. "Our priority is bringing new and effective treatments to patients. We look forward to working closely with Immutep to develop IMP321 in first-line metastatic breast cancer as well as other first-line metastatic indications.” About ImmuFact® 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% 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 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 tumors.

  • 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.

  • Chemo-immunotherapy

The objective of chemo-immunotherapy is to amplify natural pre-existing T cell responses specific for any known or unknown tumor antigen 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, such as paclitaxel, can enhance antigen loading of APC by inducing tumor 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® 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. This product is licensed to CoStim.

  • ImmuTune® IMP731

IMP731 is a depleting anti-LAG-3 antibody for autoimmune disease, licensed to GSK.

For more information, visit http://www.immutep.com.

About Eddingpharm

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.

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