OSE Pharma, an immuno-oncology company with a specific immunotherapy activating T lymphocytes, currently in a registration phase III study, and Effimune, a biotech company specialized in immune regulation with clinical applications in autoimmunity, transplantation and immune-oncology, have announce the signing of a proposed merger agreement.

The Boards of Directors of both OSE Pharma and Effimune have approved the proposed terms of the merger, which will be submitted for approval to the shareholders of the two companies during Extraordinary General Meetings that are expected to take place at the end of the second quarter of 2016. The merger will result in the shareholders of OSE Pharma owning approximately 71% of the capital of the merged entity and the shareholders of Effimune 29%.

The new company will benefit from a balanced portfolio that would open up major avenues to growth and have a financial visibility of about two years to advance its projects toward greater attractiveness.

The objective of the merger is to create a new international enterprise that offers innovative immunotherapies based on the activation or regulation of the immune system. This new generation of products is optimized to better target key receptors of the activation or regulation of immune response and allow a durable therapeutic effect.

Emile Loria, chairman of the Board of Directors and the main shareholder of OSE Pharma, said, "The merger with Effimune is a major step for both our companies, which have complementary expertise and multiple synergies. Now that our phase III registration trial of Tedopi has been launched in Europe and in the U.S. in the field of immuno-oncology, the development of other clinical and preclinical programs co-financed by grants or industrial companies opens up additional strong perspectives for growth. The proposed merger gives us a unique opportunity to create value for all of our shareholders in the rapidly growing field of immunotherapy."

Dominique Costantini, chief executive officer of OSE Pharma, said, "We are very happy to join forces with a leading team in immunotherapy and, specifically, with a group able to develop a next generation checkpoint inhibitor. We acknowledge the work of Effimune's team that, based on its experience in the field of transplantation, developed at INSERM/French Institute of Transplantation, Urology and Nephrology in Nantes, France, has established major immunotherapy projects with the support of an international leading pharmaceutical group and developed a first product, a CD28-antagonist that prevents the activation of T cells, which is currently at the end of clinical phase I. In the future, the merged entity will have a balanced portfolio, from R&D through to the last clinical phase before registration, and a diversified risk profile."

Maryvonne Hiance, Chairman of Effimune, said, "This merger capitalizes on immuno-activation and immuno-regulation technologies. It is the perfect lever to deploy our programs and optimize innovative drug candidates in the field of immuno-oncology, autoimmune diseases and transplantation. These next generation products are attractive for the pharmaceutical industry, and provide the flexibility to out-license either at an early stage or later in development, retaining more value for the group."

Assuming completion of the merger, Dominique Costantini will assume the role of chief executive officer of the new group. Maryvonne Hiance will become the vice-chairman of the Board of Directors, alongside Emile Loria, Chairman. Two independent Board Directors from Effimune will join and strengthen the Board alongside current board members of OSE Pharma.

Two chief operating officers will assist the chief executive officer: Bernard Vanhove, chief operating officer in charge of R&D and international scientific collaborations, and Alexis Peyroles, chief operating officer in charge of operations, finance, agreements and licenses within the new entity.

To reflect the change in company profile brought by the merger, it is expected that OSE Pharma will be renamed OSE Immunotherapeutics, and the headquarters will be transferred from Paris (France) to Nantes (France), reflecting Effimune's strong academic establishment.