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Ventana Developing CDx for Seattle Genetics, Millenium Cancer Drug

NEW YORK (GenomeWeb News) – Ventana is developing a companion diagnostic test for an oncology drug developed by Seattle Genetics and Millennium Pharmaceuticals under a deal announced today.

The companion diagnostic being developed by Ventana, a Roche company, will be for identifying patients who best respond to Adcetris (brentuximab vedotin) based on CD30 expression levels in their tissue specimens. Under the terms of the agreement, Ventana will develop, manufacture, and commercialize the test.

Adcetris, co-developed by Seattle Genetics and Millenium, is an antibody-drug conjugate that was approved in August 2011 by the US Food and Drug Administration for relapsed Hodgkin lymphoma and systemic anaplastic large call lymphoma. A companion diagnostic is not required for the FDA-approved indications for the drug.

As part of their ongoing clinical development work, Millenium, a wholly owned subsidiary of Takeda Pharmaceutical, and Seattle Genetics plan to conduct two phase III studies that will include use of the companion diagnostic test. One study will be for CD30-positive cutaneous T-cell lymphoma, and the other will be for CD30-positive mature T-cell lymphomas.

CD30, a member of the tumor necrosis factor receptor family, is a characteristic cell surface receptor for activated T-cells and B-cells. CD30 expression has also been reported for other cancers, and Seattle Genetics is investigating the use of Adcetris in two phase II clinical trials to further characterize CD30 expression and evaluate anti-tumor activity of the drug, the company said.

One trial targets patients with non-Hodgkin lymphomas, and the second trial is directed at patients with non-lymphoma malignancies. Adcetris is not approved for treating either indication.

"Although the identification of CD30 expression and its role in the diagnosis of Hodgkin lymphoma and systemic [anaplastic large call lymphoma] is well-established, CD30 expression in other malignancies is more heterogeneous," Thomas Reynolds, chief medical officer of Seattle Genetics, said in a statement. "The collaboration with Ventana provides an opportunity for development of a diagnostic tool to identify patients who may benefit from Adcetris treatment."

Financial and other terms of the deal were not disclosed.

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