Highly personalized medicine
January 2013
by Ilene Schneider  |  Email the author


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

The companies will work to develop a modification to the Leica Bond Oracle IHC system approved in the United States as a companion diagnostic for determining whether a patient with HER2 high expression is eligible for Herceptin. It will be used to select patients to receive Galena's NeuVax peptide-based breast cancer vaccine. The test will be used in the ongoing PRESENT Phase III trial, being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment.

NeuVax is designed to prevent recurrence in the 50 percent of breast cancer HER2 patients with low to intermediate protein expression who are not eligible to receive other therapies after initial treatment. NeuVax immunotherapy uses the patient's own immune system to target tumor cells in a highly specific, less toxic and more convenient way than conventional cancer therapies, according to the company.

Galena, a U.S.-based biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, is attempting to strengthen its NeuVax personalized medicine and regulatory pathway with companion diagnostic development, according to Dr. Mark Schwartz, executive vice president and chief operating officer.

Galena reviewed all of the companies and technologies working in the HER2 diagnostic arena, and "felt that Leica—which provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting—was best positioned from a technology and a market perspective to develop the test," he explains. "Leica has superior technology, a strong development organization and a worldwide commercial presence, all of which will facilitate the development and commercialization of the required assay."

"The Leica Bond Oracle HER2 IHC System is validated as a fully- automated HER2 IHC test, and delivers the diagnostic confidence that comes with proven HER2 FISH concordance," adds Arnd Kaldowski, president of Leica. "We are pleased to be working with Galena Biopharma to potentially expand our indication for this product to HER2 negative patients."

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

Galena is responsible for the clinical development of NeuVax, while Leica is responsible for development of the diagnostic assay. However, both companies are working closely together to assure the diagnostic has the specificity, selectivity and reproducibility to select and identify the appropriate patients for the NeuVax Phase III PRESENT trial. The companies are also collaborating on obtaining regulatory approval for the assay.

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

According to the National Cancer Institute, there are approximately 230,000 breast cancer patients diagnosed every year in the United States, and about 450,000 diagnosed annually in the European Union (EU). The current standard of care for both geographies calls for measuring levels of HER2 to determine clinically HER2 positive from HER2 negative patients at the time of breast cancer diagnosis. As more therapies such as NeuVax are developed for treating HER2 negative patients, including triple-negative patients (HER2 negative, ER and PR negative), it is anticipated that measuring and discriminating all levels of HER2 (HER2 3+, 2+, 1+, 0) will become the standard of care with all newly diagnosed breast cancer patients. Hence, this assay could become part of the standard of care at diagnosis.

"Initially, the companies plan on seeking regulatory approval in the U.S., Canada and the EU, with subsequent approvals in most markets around the world," Schwartz concludes.

Galena, Teva in cancer deal

LAKE OSWEGO, Ore.—Galena Biopharma Inc. also announced in December that it has signed an agreement with a subsidiary of Teva Pharmaceutical Industries Ltd. for the commercialization of NeuVax, a target for therapeutic intervention in breast carcinoma, in Israel.

Based on a successful Phase II trial, which achieved its primary endpoint of disease-free survival, the U.S. Food and Drug Administration granted NeuVax a Special Protocol Assessment for its Phase III study of prevention of recurrence in early-stage, node-positive breast cancer with low to intermediate HER2 expression.

Under the agreement, Teva Israel will assume responsibility for regulatory registration in Israel, provide financial support for local development and commercialize the product in the region. Specific financial terms were not disclosed, but the agreement allows for significant royalty payments to Galena Biopharma on future sales.
Code: E011314

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