BioWorld International Correspondent

PARIS - Innate Pharma SAS signed an agreement with Schering-Plough Corp. covering the acquisition of technologies and the licensing of intellectual property rights to certain Schering-Plough products based on the pharmacological manipulation of Toll-like receptors (TLRs).

At the same time, Innate Pharma signed a collaboration with the Institut Gustave-Roussy (IGR), France's leading cancer center, with which Innate already conducted a comprehensive retrospective analysis of the TLR3 agonist approach that yielded promising results.

Innate Pharma, of Marseille, France, is developing new classes of drug candidates targeting the innate immune system, focusing initially on cancer.

The company turned its attention to the pharmacological manipulation of TLR in September, after obtaining promising initial results with its first two platforms of immunotherapeutic products targeting non-conventional lymphocytes - gamma delta T cells and natural killer cells. The company's lead product, IPH 1101, a gamma delta T-cell agonist, entered a Phase II trial in renal cancer at the beginning of June.

The first drug candidate to emerge from Innate's TLR platform, IPH 31XX, is an agonist to the TLR3 receptor. The company intends to develop the product in several indications as a targeted immunotherapy addressing TLR3-positive cancers, especially TLR3-positive breast cancers. Innate Pharma said that TLR3-positive breast cancers account for 5 percent to 10 percent of all breast cancers.

Innate expects IPH 31XX to enter clinical trials in 2008 and would like to develop it together with a diagnostic kit to provide an individualized therapy that specifically targets TLR3-positive cancer populations.

The agreement between Innate and Schering-Plough, of Kenilworth, N.J., gives the U.S. company in exchange some rights to Innate's TLR3 product candidates in non-European territories under certain specified conditions and up to a certain stage of development. The financial and other terms of the agreement were not disclosed.

Innate's past collaboration with the IGR, which is based in the Paris suburb of Villejuif, entailed the retrospective immunostaining of breast cancer biopsies from 175 patients with node-positive disease who had been included in a prospective randomized trial comparing a synthetic dsRNA, Poly(A:U), to placebo. It demonstrated that only patients with TLR3-positive breast cancer had a prolonged survival after receiving Poly(A:U).

Innate concluded that both the improved survival of patients with TLR3-positive breast cancer and the lack of efficacy in TLR3-negative cancers argued against non-specific immuno-stimulation by Poly(A:U) and suggested instead a direct effect of the TLR3 agonist on cancer cells.

The Phase II trial of Innate's lead candidate, IPH 1101, is in metastatic renal carcinoma (mRCC), the indication for which it was granted orphan drug status by the European Medicines Evaluation Agency in 2004. The drug earlier completed a successful Phase I trial in mRCC, as well as one in solid tumors. Moreover, a third Phase I is under way in non-Hodgkin's lymphoma.