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Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3 BEACON Study of Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer at the 2013 American Society of Clinical Oncology Annual Meeting

Nektar Therapeutics (NASDAQ:NKTR) recently announced that it presented a series of target-specific biomarkers that are being evaluated in the development of etirinotecan pegol for the treatment of breast cancer. Etirinotecan pegol is a unique, next generation, targeted topoisomerase I inhibitor currently in Phase 3 clinical development as a potential treatment for patients with locally recurrent or metastatic breast cancer. The BEACON (BrEAst Cancer Outcomes with NKTR-102) Phase 3 Study is a randomized, open-label, international study that is evaluating single agent etirinotecan pegol in patients who have previously received an anthracycline, a taxane and capecitabine (ATC) versus a comparator arm consisting of an active single agent treatment of physician’s choice (TPC).

“One of our objectives in treating metastatic breast cancer is to prospectively identify patients that will respond to specific treatments so they can achieve the optimal individualized care,” said Hope Rugo, M.D., Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Comprehensive Cancer Center and Member of the BEACON Study investigator steering committee. “The goal of evaluating these important biomarkers in patients enrolled into the BEACON study is to help us understand which breast cancer patients might have the best clinical outcomes from treatment with etirinotecan pegol.”

A series of assays for target-specific pharmacodynamic biomarkers for etirinotecan pegol, including the molecular target topoisomerase I, have been established and are being measured in the Phase 3 BEACON study. The biomarkers were identified from Circulating Tumor Cell (CTC) samples which were collected prior to patient treatment. Additional CTC patient samples are being collected at regular intervals during treatment and at the end of treatment. Preliminary results from the initial pre-dose samples found CTCs in over 90% of patient samples, with a median of 200 CTCs per 7.5 mL blood draw. Patient participation in the CTC sub-set of the BEACON study is projected to be over 75%. Measurements of each biomarker expression over time will be analyzed in order to identify potential predictive biomarkers for clinical response to etirinotecan pegol.

“We are pleased to have identified several baseline pharmacodynamic biomarkers, which are target-specific such as topoisomerase 1, and which can be reliably measured over the patient’s treatment period,” said Robert Medve, M.D., Chief Medical Officer of Nektar Therapeutics. “The measurement of these biomarkers in the BEACON study will help us understand and shape the future treatment of patients with etirinotecan pegol. Enrollment in the BEACON study is well ahead of schedule and we expect to complete the target enrollment of 840 patients in the third quarter of 2013.”

Circulating Tumor Cells are cancer cells shed from either the primary tumor or its metastases that circulate in the peripheral blood. CTCs are emerging tumor biomarkers, collected through a minimally invasive blood draw, providing a “liquid” biopsy sample and allowing for post-treatment monitoring of the patient. CTCs provide well-defined targets for the understanding of tumor biology and tumor cell dissemination, which offers a unique approach to identify novel therapeutic targets and understand resistance to established therapies.

Source: Nektar Therapeutics

KineMed, Isis and CHDI Collaborate to Advance Therapeutic Development for Huntington’s Disease and Develop Novel Biomarkers for Pre-clinical and Clinical Use in Drug Development and Therapeutic Monitoring

KineMed, Inc., Isis Pharmaceuticals Inc. (NASDAQ: ISIS), and CHDI Foundation, Inc., announced today that they are collaborating to utilize KineMed’s translational biomarker platform with Isis’ antisense therapeutic program for Huntington’s disease (HD). This collaboration, which builds on an earlier alliance between CHDI and KineMed to develop companion biomarkers of therapeutic response in HD, will provide Isis access to novel biomarkers for use in the development of an antisense drug to treat HD.

“A pharmacodynamic biomarker could be an important contribution to our clinical development efforts, and we look forward to working with KineMed and CHDI to evaluate KineMed’s biomarker platform in our Huntington’s disease program,” said Frank Bennett, Ph.D., Senior Vice President of Research at Isis.

“This companion biomarker partnership represents personalized medicine in action,” said Patrizia Fanara, Ph.D., Vice President of Neuroscience KineMed. “Our neurodegeneration-specific biomarkers, which provide dynamic measures of axonal transport deficits in degenerating brain cells, predict therapeutic response in neurological and neuromuscular disorders. This is a translational biomarker that could prove crucial to the advancement of disease-modifying treatments. With the Huntington’s disease domain knowledge that CHDI brings and the therapeutic approach that Isis is pioneering, this partnership has the potential to develop biomarkers for specific therapeutics for Huntington’s disease and lead to personalized medicines for Huntington’s patients.”

“There is a critical need to identify appropriate biomarkers to determine target engagement and predict early clinical efficacy for future Huntington’s disease clinical trials,” said Jonathan Bard, Ph.D., Director of Molecular Pharmacology for CHDI Foundation. “Combining Isis’ knowledge of antisense therapies with KineMed’s expertise in developing unique pharmacodynamic biomarkers creates a collaboration with great potential for discovering such tools for Huntington’s disease.”

KineMed’s neurodegeneration biomarker of axonal transport deficit has been recently published in the Journal of Clinical Investigation1 and validated in patients with other neurological disorders.

Source: Business Wire

Takeda and Metabolon Initiate Research Collaboration to Discover Novel Targets and Biomarkers

Metabolon, Inc., a diagnostics and services company offering the industry’s leading biochemical profiling technology announces that Metabolon and Takeda Pharmaceutical Company Limited (TSE: 4502), a global pharmaceutical company, have formed a multiyear research alliance that will focus on discovering therapeutic targets and biomarkers.

Metabolon Launches Strategic Outsourcing Programs Focused on Disease Metabolism

Metabolon, Inc., a diagnostics and services company offering the industry’s leading biochemical profiling technology, announces the launch of its Disease Metabolism Strategic Outsourcing Program.

Parsortix Research Partnership with the Paterson Institute for Cancer Research

ANGLE plc (AIM: AGL) is pleased to announce that Parsortix Inc (“Parsortix”), its 90% owned portfolio company which specialises in cancer diagnostics, has signed a two year research agreement with the Cancer Research UK-funded Paterson Institute for Cancer Research, The University of Manchester’s world-leading cancer research institute.