A hankering for HER2
June 2012
by Kelsey Kaustinen  |  Email the author


GLOSTRUP, Denmark—Dako and Genentech, a member of the Roche Group, have announced the signing of an agreement to collaborate on the regulatory submissions of two of Dako's cancer diagnostics. The two companies will collaborate on the U.S. Food and Drug Administration submissions for HercepTest and HER2 FISH pharmDx as companion diagnostics for one of Genentech's investigational drug candidates, trastuzumab emtansine (T-DM1), which is indicated for patients with advanced HER2-positive breast cancer. No financial details were disclosed.  
"At Dako, we are constantly looking for new opportunities to move pathology forward, and we see this new agreement as a sign of confidence in Dako's leading competencies within the area of companion diagnostics," Lars Holmkvist, CEO of Dako, said in a press release.  
T-DM1 is an antibody drug conjugate currently being studied in HER2-positive cancers as an inhibitor of HER2 signaling. The drug binds to HER2-positive cancer cells, delivering the chemotherapy agent internally, and is believed to block rampant signals that lead to cancer growth while also inciting the immune system to attack the cancerous cells.  
Dako's HercepTest is a semi-quantitative immunohistochemical assay for determining the over-expression of HER2 protein in breast cancer tissues and formalin-fixed, paraffin-embedded (FFPE) cancer tissues from patients with either metastatic gastric or gastroesophageal junction adenocarcinoma. The HER2 FISH pharmDx is a direct fluorescence in-situ hybridization (FISH) assay for quantitatively determining HER2 gene amplification in FFPE breast cancer tissue samples and FFPE samples from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Both tests are indicated for aiding clinicians in assessing patients who might benefit from treatment with Herceptin. In addition, results from the HER2 FISH pharmDx test are intended for use as an adjunct for estimating prognosis in stage II, node-positive breast cancer patients.
The collaboration is in keeping with Dako's strategy to partner with pharmaceutical companies in an effort to further develop its portfolio of companion diagnostic assays, and is in fact the company's second partnership with Genentech. The first collaboration was announced in December of last year, focused on the regulatory submissions of HercepTest and HER2 FISH pharmDx as companion diagnostics for Pertuzumab, an investigational drug candidate of Genentech's indicated for patients with advanced HER2-positive breast cancer.  
Genentech is not the only company with whom Dako has sought diagnostics partnerships. Earlier this year in January, Dako announced that it had begun a development and collaboration agreement with Amgen to develop a diagnostic test for a drug candidate of Amgen's indicated for a rare cancer target. No financial details were disclosed, nor were the drug candidate or cancer target revealed. Holmkvist noted in a press release regarding the agreement that he was proud the companies had "succeeded in putting together a business model that supports the concurrent development of drug and diagnostics for a low-incidence cancer." Dako and Amgen announced an additional collaboration in February to develop a companion diagnostic test for one of Amgen's cancer therapy drugs currently in clinical development.
"It is a pleasure to welcome Genentech as a partner once again," Holmkvist said of the most recent collaboration. "Working with Genentech on this FDA submission for companion diagnostics for trastuzumab emtansine is another important step forward in our relentless commitment to fighting cancer."  
In the company's most recent development, Dako announced May 17 the signing of a definitive agreement between Agilent Technologies Inc. and EQT V, the Sweden-based private equity firm that owns Dako. Under the agreement, Agilent will acquire Dako for $2.2 billion on a debt-free basis. Assuming all customary closing conditions are met, the transaction is expected to close in the second quarter of the year. The all-cash deal is expected to be immediately accretive to Agilent's earnings on a non-GAAP basis.

Genentech, Lorus Therapeutics ink licensing deal  
TORONTO—Genentech also recently entered into a global licensing agreement with Lorus Therapeutics Inc., a biopharmaceutical company focused on cancer, for certain patents owned by Genentech for IL-17E.
IL-17E is a recently identified cytokine that plays an important role in inflammation. Lorus has discovered that human IL-17E has potent anticancer properties against a range of solid tumors, including human melanoma, pancreatic, colon, lung, ovarian and breast tumor models with very low toxicity. IL-17E is highly potent and does not require further modification or optimization before proceeding to the formal IND-enabling preclinical studies planned to support advancing to a Phase I clinical trial. Lorus has selected pancreatic cancer and malignant melanoma as the initial lead cancer indications for this agent.  
"We are excited about obtaining this license from Genentech, which will enable Lorus to develop this program as a novel and exciting treatment for a large number of cancers," said Dr. Aiping Young, president and CEO of Lorus, in a statement. "Lorus scientists were the first to discover the anticancer properties of IL-17E, and we have patents pending for the use of IL-17E in cancer in the major world markets. IL-17E represents a unique immunotherapeutic approach to the treatment of some of the most important cancers, and preclinical data to date shows excellent efficacy with low toxicity—properties that we plan to demonstrate in the clinic in the near future."
Detailed financial terms of the licensing agreement were not disclosed.
Code: E061215

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