A hankering for HER2

Dako, Genentech pair up for FDA submissions of HER2 companion diagnostics

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GLOSTRUP, Denmark—Dako and Genentech, a member of the RocheGroup, have announced the signing of an agreement to collaborate on theregulatory submissions of two of Dako's cancer diagnostics. The two companieswill collaborate on the U.S. Food and Drug Administration submissions forHercepTest and HER2 FISH pharmDx as companion diagnostics for one ofGenentech's investigational drug candidates, trastuzumab emtansine (T-DM1),which is indicated for patients with advanced HER2-positive breast cancer. Nofinancial details were disclosed.
"At Dako, we are constantly looking for new opportunities tomove pathology forward, and we see this new agreement as a sign of confidencein Dako's leading competencies within the area of companion diagnostics," LarsHolmkvist, CEO of Dako, said in a press release.
T-DM1 is an antibody drug conjugate currently being studiedin HER2-positive cancers as an inhibitor of HER2 signaling. The drug binds toHER2-positive cancer cells, delivering the chemotherapy agent internally, andis believed to block rampant signals that lead to cancer growth while alsoinciting the immune system to attack the cancerous cells.
Dako's HercepTest is a semi-quantitative immunohistochemicalassay for determining the over-expression of HER2 protein in breast cancertissues and formalin-fixed, paraffin-embedded (FFPE) cancer tissues frompatients with either metastatic gastric or gastroesophageal junctionadenocarcinoma. The HER2 FISH pharmDx is a direct fluorescence in-situ hybridization (FISH) assay for quantitativelydetermining HER2 gene amplification in FFPE breast cancer tissue samples andFFPE samples from patients with metastatic gastric or gastroesophageal junctionadenocarcinoma. Both tests are indicated for aiding clinicians in assessingpatients who might benefit from treatment with Herceptin. In addition, resultsfrom the HER2 FISH pharmDx test are intended for use as an adjunct forestimating prognosis in stage II, node-positive breast cancer patients.
The collaboration is in keeping with Dako's strategy topartner with pharmaceutical companies in an effort to further develop itsportfolio of companion diagnostic assays, and is in fact the company's secondpartnership with Genentech. The first collaboration was announced in Decemberof last year, focused on the regulatory submissions of HercepTest and HER2 FISHpharmDx as companion diagnostics for Pertuzumab, an investigational drugcandidate of Genentech's indicated for patients with advanced HER2-positive breastcancer.
Genentech is not the only company with whom Dako has soughtdiagnostics partnerships. Earlier this year in January, Dako announced that ithad begun a development and collaboration agreement with Amgen to develop adiagnostic test for a drug candidate of Amgen's indicated for a rare cancertarget. No financial details were disclosed, nor were the drug candidate orcancer target revealed. Holmkvist noted in a press release regarding theagreement that he was proud the companies had "succeeded in putting together abusiness model that supports the concurrent development of drug and diagnosticsfor a low-incidence cancer." Dako and Amgen announced an additionalcollaboration in February to develop a companion diagnostic test for one ofAmgen's cancer therapy drugs currently in clinical development.
"It is a pleasure to welcome Genentech as a partner onceagain," Holmkvist said of the most recent collaboration. "Working withGenentech on this FDA submission for companion diagnostics for trastuzumabemtansine is another important step forward in our relentless commitment tofighting cancer."
In the company's most recent development, Dako announced May17 the signing of a definitive agreement between Agilent Technologies Inc. andEQT V, the Sweden-based private equity firm that owns Dako. Under theagreement, Agilent will acquire Dako for $2.2 billion on a debt-free basis.Assuming all customary closing conditions are met, the transaction is expectedto close in the second quarter of the year. The all-cash deal is expected to beimmediately accretive to Agilent's earnings on a non-GAAP basis.

Genentech, Lorus Therapeutics ink licensing deal
TORONTO—Genentech also recently entered into a globallicensing agreement with Lorus Therapeutics Inc., a biopharmaceutical companyfocused on cancer, for certain patents owned by Genentech for IL-17E.
IL-17E is a recently identified cytokine that plays animportant role in inflammation. Lorus has discovered that human IL-17E haspotent anticancer properties against a range of solid tumors, including humanmelanoma, pancreatic, colon, lung, ovarian and breast tumor models with verylow toxicity. IL-17E is highly potent and does not require further modificationor optimization before proceeding to the formal IND-enabling preclinicalstudies planned to support advancing to a Phase I clinical trial. Lorus hasselected pancreatic cancer and malignant melanoma as the initial lead cancerindications for this agent.
"We are excited about obtaining this license from Genentech,which will enable Lorus to develop this program as a novel and excitingtreatment for a large number of cancers," said Dr. Aiping Young, president andCEO of Lorus, in a statement. "Lorus scientists were the first to discover theanticancer properties of IL-17E, and we have patents pending for the use ofIL-17E in cancer in the major world markets. IL-17E represents a uniqueimmunotherapeutic approach to the treatment of some of the most importantcancers, and preclinical data to date shows excellent efficacy with lowtoxicity—properties that we plan to demonstrate in the clinic in the nearfuture."
Detailed financial terms of the licensing agreement were notdisclosed.

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