Quantcast

Industry news that matters to you.  Learn more

Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

KineMed Awarded NIH Contract to Identify Biomarkers for Myocardial Fibrosis

KineMed, Inc. (www.kinemed.com) recently announced that the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the company a Phase I SBIR (Small Business Innovation Research) contract to develop biomarkers for the detection of early myocardial fibrosis. Biomarkers for myocardial fibrosis will guide disease interventions that block the progression of this disease which is risk factor for heart failure and arrhythmias.

FDA Advisory Committee Recommends Accelerated Approval of Genentech’s Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease in which the cancer has spread to other parts of the body).

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

“More than 6,000 people in the United States die of HER2-positive breast cancer each year,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “The ODAC’s recommendation is a step toward bringing Perjeta to people with HER2-positive early stage breast cancer, where treatment can potentially prevent the disease from returning and spreading.”

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor’s size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer.

The ODAC recommendation was based on a review of results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in high-risk, HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin® (trastuzumab) and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS). Genentech has proposed this study as a confirmatory study to the FDA. Data are expected in 2016.

Source: Genentech

Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.

Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service

Almac recently announced they are now offering a Tumor Profiling service running Illumina’s next-generation sequencing (NGS) TruSight Tumor™ panel as part of their biomarker discovery, development and delivery solutions.

Almac, a personalised medicine company with CAP accredited and CLIA certified laboratories, extends their portfolio of services by offering TruSight Tumor™ to complement its current range of RNA, DNA and protein based technologies for biomarker analysis.

Almac is currently running many bespoke diagnostic assays for pharma customers for early phase clinical trial enrichment. The TruSight Tumor™ panel enables additional profiling of these patient samples to provide Almac’s pharma partners with further important information on emerging biomarkers that may also impact drug response.
The TruSight Tumor™ panel was developed by Illumina for their MiSeq® system, allowing targeted DNA sequencing and reporting on the mutation status of 26 genes which are most commonly mutated in solid tumors including lung, colon, ovarian, melanoma and gastric cancers.

One of Almac’s key strengths is many years of experience in working with formalin fixed paraffin embedded (FFPE) tissue. The TruSight Tumor™ panel is specifically designed for use with FFPE samples, and enables the highest levels of sensitivity for mutation detection with limited DNA input requirements.

“Almac is committed to the development of personalised medicine through the delivery of a wide range of innovative solutions. We are pleased to announce the expansion of our NGS service to include TruSight Tumor™” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit.

Source: Almac