BioWorld International Correspondent

PARIS - Innate Pharma SAS and Novo Nordisk A/S signed a research, development and licensing deal aimed at developing new therapeutics for cancer and possibly other diseases.

The companies plan to generate a new class of immunomodulatory antibodies targeting natural killer (NK) cells, a subset of nonconventional lymphocytes involved in immune system regulation that have a cytotoxic effect on a range of tumor targets. Marseille-based Innate Pharma recently established the validity of the strategy in leukemia patients.

Innate has granted Novo, of Bagsvaerd, Denmark, exclusive rights to one family of receptor targets expressed by NK cells. Innate has obtained preliminary proof of concept for products acting on the family. The companies will form a joint research program to develop the concept in cancer.

Novo will develop and commercialize any products and has rights for all indications. Innate Pharma will retain residual rights to develop products for orphan indications at a later stage. Also, Innate will receive license fees and shoot for milestone payments and royalties. Other financial details were not disclosed.

Innate's CEO Hervé Brailly said, "This is a very important agreement for Innate Pharma from a scientific, strategic and financial standpoint." It provides Innate with "third-party validation for its innovative approach targeting nonconventional lymphocytes," as well as brings in "significant short-term cash," he said.

However, Brailly told BioWorld International that he was not in a position to give any indication of the deal's potential pecuniary value to the company. Observing that the research was "still at the discovery stage," he emphasized its "multi-indication" potential, saying it could prove to have therapeutic value in pathologies other than cancer, such as infectious diseases.

The deal with Novo covers a different class of nonconventional lymphocytes from those targeted by the three cancer therapies Innate Pharma is developing, all of which are focused on gd cells. The company's strategy is based on controlling the activation of NK and gd cells using new groups of chemically defined agonists and antagonists. Unlike conventional lymphocytes, which activate an immune response to a pathogen that is specific to each individual, nonconventional lymphocyte (including CD1-restricted ab lymphocytes, as well as NK cells and gd T lymphocytes) do not recognize the antigen associated with an individual-specific molecule, so antigen recognition can be pharmacologically manipulated.

Innate's Innacell-gd, a cell therapy for renal carcinoma that entails the ex vivo manipulation of a new chemical entity to activate a sub-population of cells having antitumor activity (T g9d2 cells), is in a Phase I trial started a year ago. It planned to begin a Phase II trial this fall, but Brailly said its development program for Innacell-gd had slipped by several months and that the company "might now favor the approach of a directly administered drug," which would be quicker and easier to get to market.

Along those lines, Innate is developing Phosphostim, designed to stimulate the immune system by activating T g9d2 cells. It is being developed in two oncological indications - multiple myeloma and renal carcinoma - and a Phase I trial started at the end of October.

Innate's third product candidate is Kiromab, a cytotoxic monoclonal antibody designed to help treat certain cutaneous lymphomas. It is in preclinical development but could enter clinical development in 2004.

The company plans to take drug candidates as far as Phase II trials before partnering. In that regard, Brailly said it would be inclined to "partner out a cell therapy like Innacell-gd to a specialist."

Innate Pharma was founded in 1999 and has raised €25 million since then, including €20 million in a second round financing completed in July 2002.