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Analysis Published In New England Journal of Medicine Highlights Discovery of New Predictive Biomarkers for Vectibix (Panitumumab)

Amgen (NASDAQ: AMGN) recently announced the publication of a biomarker analysis of Vectibix® (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the New England Journal of Medicine, the analysis found that RAS mutations, beyond the known KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX. RAS mutations are mutations occurring in exons 2, 3 and 4 of KRAS and NRAS.

Berg Receives Frost & Sullivan 2013 Drug Discovery Technology Innovation Award

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach, was recently recognized with the 2013 North American Drug Discovery Technology Innovation Award at the Frost & Sullivan Growth, Innovation and Leadership Awards Gala, the annual event by the global research organization that highlights the most promising new innovative technology across sectors.

COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

The COPD Biomarkers Qualification Consortium (CBQC) recently announced at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, “To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them.”

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, “COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes.”

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”

The CBQC Fibrinogen Working Group is composed of the following members:

  • Bruce Miller, industry co-chair, GlaxoSmithKline
  • Ruth Tal-Singer, GlaxoSmithKline
  • Mike Lowings, GlaxoSmithKline
  • Ubaldo Martin, AstraZeneca
  • Jeff Snyder, Boehringer-Ingelheim
  • Kay Tetzlaff, Boehringer-Ingelheim
  • Armin Furtwaengler, Boehringer-Ingelheim
  • Nicholas Locantore, GlaxoSmithKline
  • Nancy Leidy, Evidera
  • Amber Martin, Evidera
  • Jason Simeone, Evidera
  • David Mannino, academic co-chair, University of Kentucky
  • Stephen Rennard, University of Nebraska
  • David Lomas, University College London, U.K.
  • Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
  • Graham Barr, Columbia University
  • Debora Merrill, COPD Foundation

Source: COPD Foundation

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

Broad Institute and Bayer Join Forces to Develop Novel Treatment Options in Cancer Therapy

The Broad Institute has entered into a strategic alliance with Bayer Healthcare in the area of oncogenomics and drug discovery. The goal of this collaboration is to jointly discover and develop therapeutic agents that selectively target cancer genome alterations over a period of five years.

“We look forward to working together with our Bayer colleagues to translate scientific discoveries into novel cancer therapeutics,” said Professor Eric Lander, President and Director of Broad Institute. “The Broad’s deep expertise and knowledge in cancer genomics, chemical biology and drug discovery perfectly complement Bayer’s decades of experience in pharmaceutical development. We are thrilled to be working with Bayer in such a visionary collaboration.”

Oncogenomics is a promising field of oncology research that identifies and characterizes genes which are associated with cancer. Cancer is caused by the accumulation of DNA mutations which lead to uncontrolled cell proliferation and tumor formation. The goal of oncogenomics research is to identify new genes which, when mutated, stimulate or lose the ability to suppress tumor cell growth. These genes may provide new insights into cancer diagnosis, prediction of clinical outcomes, and new targets for cancer therapies. Targeting individual patient tumor mutations will allow for the development of more personalized cancer treatments.

“We are excited to collaborate with such a prestigious research institute as the Broad Institute which brings together researchers from Harvard, MIT, and the Harvard hospitals,” said Professor Andreas Busch, Head of Global Drug Discovery and Member of the Executive Committee of Bayer HealthCare. “The Broad Institute’s scientists have created impressive systematic catalogues of mutational changes across different types of tumors, laying a foundation for the development of new cancer therapies and diagnostics. The alliance is another significant step underlining our engagement in the field of oncology and personalized medicine.”

As part of the collaboration, the Broad Institute will share its oncogenomic expertise. Both parties will explore their compound libraries and use their screening platforms as well as medicinal chemistry expertise to benefit joint projects. The collaboration will be based on joint decision-making and the rights to the research findings are shared equally between the partners. Joint research and joint steering committees will be established for the initiation and selection of projects, and as governance structures. Bayer will have an option for an exclusive license for therapeutic agents at preclinical development stage. Financial terms of the agreement were not disclosed.

Source: Broad Institute