Highly personalized medicine

Galena and Leica develop companion diagnostic for breast cancer therapeutic

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LAKE OSWEGO, Ore.—A partnership todevelop a screening technology to determine the eligibility ofpatients to participate in a clinical trial could be very good newsfor a specific group of breast cancer patients. Galena Biopharma Inc.and Leica Biosystems have joined forces to develop a companiondiagnostic to more accurately screen tissue in breast cancer patientswith low-to-intermediate (1+/2+) HER2/neu protein expression forGalena's NeuVax (nelipepimut-S or E75) breast cancer therapeutic.

The companies will work to develop amodification to the Leica Bond Oracle IHC system approved in theUnited States as a companion diagnostic for determining whether apatient with HER2 high expression is eligible for Herceptin. It willbe used to select patients to receive Galena's NeuVax peptide-basedbreast cancer vaccine. The test will be used in the ongoing PRESENTPhase III trial, being conducted under a U.S. Food and DrugAdministration (FDA) Special Protocol Assessment.

NeuVax is designed to preventrecurrence in the 50 percent of breast cancer HER2 patients with lowto intermediate protein expression who are not eligible to receiveother therapies after initial treatment. NeuVax immunotherapy usesthe patient's own immune system to target tumor cells in a highlyspecific, less toxic and more convenient way than conventional cancertherapies, according to the company.

Galena, a U.S.-based biotechnologycompany focused on developing innovative, targeted oncologytreatments addressing major unmet medical needs to advance cancercare, is attempting to strengthen its NeuVax personalized medicineand regulatory pathway with companion diagnostic development,according to Dr. Mark Schwartz, executive vice president and chiefoperating officer.

Galena reviewed all of the companiesand technologies working in the HER2 diagnostic arena, and "feltthat Leica—which provides anatomical pathology laboratories andresearchers a comprehensive product range for each step in thepathology process, from sample preparation and staining to imagingand reporting—was best positioned from a technology and a marketperspective to develop the test," he explains. "Leica hassuperior technology, a strong development organization and aworldwide commercial presence, all of which will facilitate thedevelopment and commercialization of the required assay."

"The Leica Bond Oracle HER2 IHCSystem is validated as a fully-automated HER2 IHC test, and deliversthe diagnostic confidence that comes with proven HER2 FISHconcordance," adds Arnd Kaldowski, president of Leica. "We arepleased to be working with Galena Biopharma to potentially expand ourindication for this product to HER2 negative patients."

According to Schwartz, Galena is theleader in developing therapeutics targeting HER2 1+ or 2+ (HER2negative) breast cancer patients, and Leica is committed to being theleader in immunohistochemistry (IHC) testing. This patientpopulation, an unmet medical need, is greatly underserved compared tothe HER2 positive patient population. Both companies are committed todeveloping products to meet this need.

Galena is responsible for the clinicaldevelopment of NeuVax, while Leica is responsible for development ofthe diagnostic assay. However, both companies are working closelytogether to assure the diagnostic has the specificity, selectivityand reproducibility to select and identify the appropriate patientsfor the NeuVax Phase III PRESENT trial. The companies are alsocollaborating on obtaining regulatory approval for the assay.

The assay will be able to identify anddistinguish not only HER2 positive patients from HER2 negativepatients, but it will also distinguish patients with no HER2expression from patients with low HER expression.

According to the National CancerInstitute, there are approximately 230,000 breast cancer patientsdiagnosed every year in the United States, and about 450,000diagnosed annually in the European Union (EU). The current standardof care for both geographies calls for measuring levels of HER2 todetermine clinically HER2 positive from HER2 negative patients at thetime of breast cancer diagnosis. As more therapies such as NeuVax aredeveloped for treating HER2 negative patients, includingtriple-negative patients (HER2 negative, ER and PR negative), it isanticipated that measuring and discriminating all levels of HER2(HER2 3+, 2+, 1+, 0) will become the standard of care with all newlydiagnosed breast cancer patients. Hence, this assay could become partof the standard of care at diagnosis.

"Initially, the companies plan onseeking regulatory approval in the U.S., Canada and the EU, withsubsequent approvals in most markets around the world," Schwartzconcludes.

Galena, Teva in cancer deal

LAKE OSWEGO, Ore.—Galena BiopharmaInc. also announced in December that it has signed an agreement witha subsidiary of Teva Pharmaceutical Industries Ltd. for thecommercialization of NeuVax, a target for therapeutic intervention inbreast carcinoma, in Israel.

Based on a successful Phase II trial,which achieved its primary endpoint of disease-free survival, theU.S. Food and Drug Administration granted NeuVax a Special ProtocolAssessment for its Phase III study of prevention of recurrence inearly-stage, node-positive breast cancer with low to intermediateHER2 expression.

Under the agreement, Teva Israel willassume responsibility for regulatory registration in Israel, providefinancial support for local development and commercialize the productin the region. Specific financial terms were not disclosed, but theagreement allows for significant royalty payments to Galena Biopharmaon future sales.

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