Sanofi-aventis announced that sanofi-aventis US Inc. has signed a worldwide research and development agreement with Merck KGaA, Darmstadt, Germany, under which Merck’s division Merck Serono and sanofi-aventis US Inc. will collaboratively investigate novel experimental combinations of agents that could block specific pathways in cancer cells. This collaboration could deliver novel targeted oncology treatments with high therapeutic potential.

The novel combinations involve Merck Serono’s MEK inhibitor MSC1936369B (also known as AS703026), sanofi-aventis PI3K/mTOR inhibitor SAR245409 (also known as XL765) and class I PI3K inhibitor SAR245408 (also known as XL147), respectively.

Under the terms of this agreement, each party will be initially responsible for conducting a phase I dose escalation study of these product candidates. Sanofi-aventis will be granted a research and development license to MSC1936369B to assess safety and initial clinical activity in combination with its PI3K inhibitor SAR245408. In conjunction, Merck Serono will be granted a research and development license to SAR245409 in order to assess safety and initial clinical activity in combination with its MEK inhibitor MSC1936369B.

“This collaboration reinforces our commitment to maximize our portfolio and to provide better treatments for patients with cancer,” said Debasish Roychowdhury, M.D., senior vice president, head of global oncology, sanofi-aventis. “Combining these promising molecules makes eminent sense and we are excited to partner with Merck Serono.”  

“In the spirit of personalizing and stratifying cancer care, it is a logical step to combine new exciting molecules across pipelines and companies early on, to explore combined activity against cancer pathways,” said Dr Wolfgang Wein, executive vice president for oncology at Merck Serono. “We expect a strong synergy between both oncology units in driving the projects forward.”

SAR245408 is an inhibitor of class I PI3K (Phosphoinositol 3 Kinase). SAR245409 is a dual inhibitor of PI3K and mTOR (mammalian Target of Rapamycin). Both compounds have been shown to effectively block downstream signalling and are in early clinical development as monotherapy and in combination with standard of care. Results of six ongoing Phase I clinical trials were presented at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO).

MSC1936369B is Merck Serono’s experimental selective inhibitor of protein kinases MEK1 and MEK2 (MAP/ERK kinase 1 and 2) effectively blocking downstream protein signalling. It is in early clinical development as monotherapy and in combination with standard of care. At the 2010 annual ASCO meeting the first results have been presented from the on-going phase I safety, pharmacokinetic and pharmacodynamic study of MSC1936369B in advanced solid tumours, where first signs for anti-tumour activity observed.

ERK = Extracellular signal-regulated kinase; MAPK = Mitogen-activated protein kinase; MEK = MAP/ERK kinase; mTOR = Mammalian target of rapamycin; PI3K = Phosphoinositol 3-kinase

Sanofi-aventis Oncology is targeting cancer on several fronts in an effort to address unmet medical needs for a broad range of patients. Starting with a deep understanding of the mechanisms by which cancers develop, grow and spread, as well as translating this deep scientific understanding early in the drug discovery process, the company employs innovative approaches to bring the right medicines to the right patients. There are currently more than 10 compounds in development across a broad scientific platform, including targeted, cytotoxic, and antiangiogenic approaches employing both novel chemical entities and monoclonal antibodies.

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