On May 26, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of molecular diagnostic testing products and life science tools for translational research, reported that Cigna has issued a positive Medical Coverage Policy decision for the Prosigna Breast Cancer Gene Signature Assay (Press release, NanoString Technologies, MAY 26, 2016, View Source [SID:1234512804]). Cigna and its roughly 13 million members join other payors now covering Prosigna, collectively representing more than 135 million covered lives throughout the United States.

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This positive coverage decision is in line with updated ASCO (Free ASCO Whitepaper) guidelines released in February, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.

"Cigna’s decision to cover Prosigna is another milestone in expanding access to this state-of-the-art-test," said Brad Gray, president and chief executive officer of NanoString Technologies. "We estimate that more than 80% of patients indicated for Prosigna testing are now covered and our team is dedicated to working with the remaining health insurance providers to ensure that their patients have access to this important test."

The updated healthcare policy for Cigna, which now includes the Prosigna Assay, is available on its website:
View Source

About the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory.

In the United States, the Prosigna Assay is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.

For more information, please visit www.prosigna.com.

On May 26, 2016 Cancer Research Technology and Pangaea Biotech reported to sign license agreement for new cancer drugs (Press release, Cancer Research Technology, 26 26, 2016, View Source [SID1234523185]).

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These promising new drugs have been developed by scientists at CRT’s Discovery Laboratories with support from Cancer Research UK-funded scientists at King’s College London.

PAK is involved in cell growth and survival and is overexpressed in many cancers including ovarian, breast, pancreatic, melanoma and lung. Scientists hope that the PAK inhibitors will block the activity of overexpressed PAK protein – killing cancer cells. Although researchers have linked PAK with tumour development, there are no approved compounds available on the market.

Under the terms of the agreement, Pangaea Biotech will be responsible for research and development of the PAK inhibitors, taking CRT’s compounds through clinical development. CRT will receive undisclosed upfront and downstream payments.

CRT and Pangea Biotech will work collaboratively to complete lead optimisation, then Pangaea will assume responsibility for pre-clinical and clinical development.

Javier Rivela, CEO of Pangaea Biotech, said: "This strategic agreement maximises the capabilities of both parties, with CRT focusing on the earlier stages of development involving specialised medicinal chemistry work, and Pangaea on regulatory preclinical development, early stage clinical trials and development of biomarkers, where our main abilities and experience lie.

"We are excited about this partnership as it marks the beginning of what we expect to be a fruitful long-term collaboration with one of the most important global players in cancer drug development."

Dr Phil L’Huillier, CRT’s director of business management, said: "It’s fantastic to see this new investment in Cancer Research UK-funded science that has progressed through our Discovery Laboratories. We look forward to working with Pangaea to develop the PAK inhibitor for clinical trials."

CRT’s Discovery Laboratories build on Cancer Research UK’s investment in world-class research and focus on forming drug discovery alliances with industry, to develop potential novel therapies based on the cancer targets identified in academic research.

On May 26, 2016 OncoResponse, an immuno-oncology antibody discovery company, reported an investment from Baxalta Incorporated (NYSE: BXLT) (Press release, OncoResponse, MAY 26, 2016, View Source [SID1234522899]). In October 2015, OncoResponse closed a Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating . The investment by Baxalta brings the total Series A to $12.5 million and will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

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OncoResponse utilizes a validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer immunotherapy. The company has an ongoing strategic alliance with the MD Anderson Cancer Center, which provides access to patient samples and oncology and translational medicine expertise including clinical and regulatory input.

"We are pleased to welcome Baxalta to our solid team of investors," said Clifford J. Stocks, CEO of OncoResponse. "Our current partnership with MD Anderson has seen significant progress, and this additional investment reinforces our continued commitment to the identification of rare cancer-fighting antibodies and novel targets that may lead to the development of improved cancer treatments."

"This investment will assist OncoResponse in the advancement of its research programs which seek to develop a deeper understanding of the immune response in patients who have responded exceptionally well to cancer immunotherapy," said Geeta Vemuri, PhD, Managing Venture Partner at Baxalta. "Their innovative approach is in line with Baxalta’s investment strategy to accelerate the development of cuttingedge biotechnologies that address unmet patient needs in hematology, immunology and oncology."