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Plexxikon and Roche Enter Partnership

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Plexxikon Inc. and Roche have announced they have entered into an agreement to develop and commercialize PLX4032, Plexxikon’s investigational targeted cancer therapy which selectively inhibits B-RafV600E, a mutated form of the BRAF kinase gene.

The BRAFV600E gene has been associated with increased tumor aggressiveness and decreased survival in many types of cancers and is a common cancer-causing kinase gene.

The BRAFV600E gene is found in approximately 70% of malignant melanomas and a large number of colorectal and thyroid tumors.

PLX4032 may offer a treatment modality for the estimated 100,000 cancer patients in the United States who carry the BRAFV600E gene.

Plexxikon recently filed an Investigational New Drug (IND) application for PLX4032 and plans to initiate a Phase 1 clinical trial by the end of this year.

Separately, Roche Molecular Diagnostics, a business unit of Roche Diagnostics, and Plexxikon announced they will collaborate on development of an in vitro assay to screen for the presence of the BRAFV600E mutation in biological samples taken from patient tumors.

An assay that correlates the presence of this mutation with clinical outcome may aid clinical development of PLX4032.

"As one of the leading pharmaceutical companies in oncology, together with their commitment to personalized medicine, Roche makes an ideal partner for the development of this unique compound," said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon Inc.

"We believe PLX4032 could be a first-in-class oral cancer therapeutic which selectively targets an oncogenic protein found only in diseased tissue."

"Along with our Phase 2 diabetes product and preclinical stage portfolio in multiple therapeutic areas, PLX4032’s entry into development further validates Plexxikon’s discovery platform for novel drug candidates."

"There is a growing body of evidence demonstrating that agents such as PLX4032, which selectively inhibit activated kinases, are increasingly useful in treating cancer and improving patient outcomes," said Peter Hug, Roche’s Global Head of Pharma Partnering.

"We are very excited to partner with Plexxikon for the development of PLX4032 and other B-RafV600E targeted compounds. This could be a further example of the potential of personalized medicine."

"With our combined expertise in diagnostic and therapeutic development as well as commercialization, we are confident in our capability to develop this potential drug to make a difference to patients’ lives."

Under the terms of the agreement, Roche will pay Plexxikon $40 million as an upfront payment and a further $6 million in guaranteed research funding over the next two years. 

In addition, Plexxikon could potentially receive up to approximately $660 million over the term of the collaboration based on the completion of a series of development and commercial milestones for multiple indications and/or multiple compounds, as well as royalties on potential product sales. 

Also under the collaboration, Roche and Plexxikon will jointly develop PLX4032 and follow on compounds targeting other BRAF kinase mutations.

Plexxikon has filed an IND application for PLX4032, and will conduct a Phase 1 dose escalation study in patients with cancer, including melanomas. 

Roche will have a worldwide, exclusive license to develop and commercialize PLX4032, in addition to other anticancer compounds resulting from the partnership.

Plexxikon retains the right to co-promote any product in the collaboration in the United States.