BioWorld International Correspondent

PARIS - Innate Pharma SAS and the Danish pharmaceutical company Novo Nordisk A/S entered into a strategic partnership to develop new drugs targeting natural killer (NK) cells for the treatment of cancer, autoimmune disorders and infectious diseases.

The companies will undertake a research and development program based on NK cell biology that will build on Innate Pharma's past discoveries in the field of NKs, a subset of non-conventional lymphocytes involved in immune system regulation that have a direct cytotoxic effect on a wide range of tumor targets, among other things.

The companies, which have been collaborating in the field of NK cells for the past three years, are committed to continuing the collaboration for another three years at least.

Each will contribute relevant intellectual property rights, expertise and R&D personnel to the collaboration on an exclusive basis, and at least 40 full-time employees evenly split between the companies will be dedicated to it.

There is no limit on the number of drug candidates that could emerge from the collaboration, but the companies' objective is to have at least one compound in clinical trials within the first three years, two new lead candidates in preclinical development and three more early stage projects under way.

Novo Nordisk, of Copenhagen, will be the exclusive licensee of all drug candidates developed under the agreement, although Innate Pharma will retain some rights to specific niche indications under certain conditions.

Innate Pharma stands to receive up to €25 million in the form of an up-front payment, R&D funding and preclinical milestone payments during the three-year period. The French company also will be eligible for developmental and regulatory milestones (up to approximately €25 million per drug candidate, from the first IND to first commercial sales), as well as royalties on future product sales.

As part of the agreement Novo Nordisk, which already is a minority shareholder in Innate Pharma, is to acquire new Innate Pharma stock for €10 million, increasing its shareholding in the Marseille, France-based company to 20 percent. Moreover, in the event that Innate Pharma decided to launch an initial public offering, Novo Nordisk said it would "participate actively in it in certain circumstances."

The two companies originally signed a research, development and licensing deal in December 2003 aimed at developing new therapeutics for cancer and possibly other diseases. They indicated at the time that they hoped to generate a new class of immuno-modulatory antibodies targeting NK cells. The deal granted Novo Nordisk exclusive rights to one family of receptor targets expressed by NK cells and provided for it alone to develop and commercialize any products arising from the collaboration.

In June 2005, Innate announced that it had attained its first milestone under the collaboration for moving one lead candidate into preclinical development. The product concerned is a monoclonal antibody that blocks an inhibitory NK cell receptor, thus stimulating NK cell activity.

During the next phase of their collaboration, the companies hope to build a portfolio of new drug candidates, some of which may originate from their own research while others will be licensed in from third parties.

The new compounds they plan to develop - mainly antibodies - will be designed to stimulate or inhibit NK cell activity. Although the partnership covers all therapeutic indications, the focus primarily will be on cancer, autoimmune disorders and infectious diseases. The collaboration aims to bring drug candidates through preclinical trials, at which point Novo Nordisk will take charge of their clinical development and regulatory filing.

Novo Nordisk is a world leader in diabetes and insulin delivery systems, as well as in growth hormone and hormone replacement therapy, while Innate Pharma is specialized in immunotherapeutics for cancer. The French company is developing product platforms based on three proprietary targets relating to cell receptors, NK cells and Toll receptors, and has established proof of concept in all three. In addition, it is developing a new generation of cytotoxic antibodies specifically targeting certain cancers.

Its lead product is Phosphostim, a cell receptor agonist that is about to be tested in a Phase II clinical trial in metastatic renal cell carcinoma. A Phase I trial of the product in hematological cancers is also under way. Moreover, the active ingredient of Phosphostim, BrHPP, is being developed as an autologous cell therapy under the name of Inacell and has completed a Phase I trial in kidney cancer.

Innate Pharma's NK cell program now is bound up entirely with Novo Nordisk. According to its CEO, Hervé Brailly, the expansion of their collaboration to include a new group of targets "provides very important visibility to one of our three product platforms, consolidating Innate Pharma's leadership in immunotherapy targeting the innate immune system."

For his part, the head of Novo Nordisk's Biopharmaceuticals Research Unit, Terje Kalland, said: "The expansion of our partnership to include a new group of targets underscores Novo Nordisk's beliefs in the promise of NK-receptor biology and is a natural consequence of our successful collaboration with Innate Pharma. The agreement has a very strong strategic fit to our emerging pipeline within oncology and inflammation. Moreover, the equity investment in Innate Pharma . . . underlines our commitment to our new protein strategy and to making successful alliances with leading biotech companies."