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Bayer HealthCare to Collaborate with Sysmex Inostics GmbH to Develop Blood-based Companion Diagnostic Tests in Oncology

Bayer HealthCare has entered into a master collaboration agreement with the diagnostic company Sysmex Inostics GmbH for the development of companion diagnostics for targeted cancer therapies. The innovative blood-based companion diagnostic solutions offered by Sysmex Inostics will complement anti-cancer agents developed by Bayer.

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

Northwestern Medicine Enrolls First Participant in Midwest for Research Study of Personalized Vaccine for Aggressive Brain Tumors

Northwestern Medicine® recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase II trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM). The study is the largest randomized brain tumor vaccine trial ever funded by the National Cancer Institute (NCI) and is chaired by Andrew T. Parsa, MD, PhD, who joined Northwestern Memorial Hospital in July as the new chair of neurological surgery. The first participant in the Midwest, and only third in the country, was enrolled in the trial last week at Northwestern Memorial.

The trial will enroll more than 200 participants with recurrent glioblastoma that can be surgically removed. Following the participant’s surgery, the tumor is sent to an industry collaborator Agenus Inc., where the participant’s specific personalized vaccine, designated as HSPPC-96, is created. The vaccine is unique to the individual participant and is engineered to trigger an immune system response to kill tumor cells that may remain following surgery.

“This is truly personalized medicine where the patient’s own tumor is being used to help fight their cancer,” said Parsa, who is also the Michael J. Marchese Professor and chair of the department of neurological surgery at Northwestern University Feinberg School of Medicine and a member of the of Robert H. Lurie Comprehensive Cancer Center of Northwestern University and part of the Northwestern Brain Tumor Institute. “The vaccine provokes a tumor-specific immune response that is specific to that patient. The T cells, which are the part of the immune system that fights disease, tracks down the cancer cells and kills them.”

Parsa launched this area of research in 2006 at the University of California, San Francisco (UCSF). Previous phases of this research have returned promising results finding that the vaccine extended survival for participants with glioblastoma when compared to standard therapies. In this next phase, researchers are seeking to understand if the vaccine is safe and more effective when given with Avastin, a drug that is known to shrink brain tumors and is a standard therapy for recurrent glioblastoma. Trial participants will be randomized to either receive the vaccine alone, concurrently with Avastin or Avastin only. Jeffrey Raizer, MD, co-director of the Northwestern Brain Tumor Institute (NBTI), is the principal investigator for the trial at Northwestern.

“This vaccine therapy has the potential to extend the lives of patients who often have limited options when their tumor returns,” said Raizer, medical director of neuro-oncology at Northwestern Memorial, associate professor of neurology at the Feinberg School and a member of the Lurie Cancer Center. “Previous results indicate that we may be able to extend survival longer by combining the therapy with other drugs, such as Avastin, that may boost the immune response of the vaccine.”

Each year, 17,000 Americans are diagnosed with glioblastoma, a particularly aggressive form of brain cancer. This type of tumor is often resistant to standard therapies and median survival is approximately 15 months from the point of first diagnosis.

“This research does not present a cure for brain tumors, but instead a potential way to convert the cancer into a chronic disease – something comparable to diabetes that you may be able to live with and control with medication,” said Parsa.

A successful trial could lead to the vaccine potentially being approved to treat recurrent brain tumors, making it one of only a few approved therapeutic cancer vaccines.

“Vaccine therapy is rapidly emerging as a potential treatment for many types of cancers and we’re proud that Northwestern is part of this exciting research,” said Steven T. Rosen, MD, director of the Lurie Cancer Center, director of cancer programs at Northwestern Memorial, and Genevieve E. Teuton Professor of Medicine at the Feinberg School. “This field of research has the potential to offer safer and less toxic cancer therapies that can be personalized to each individual patient.”

The study is sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI, and the vaccine is being developed by Agenus Inc. Parsa has not received any financial support or travel expense from the company.

To learn more about the clinical trial, call 312-695-2047 or email kskirnyk@nmff.org. Enrollment criteria can be viewed on the Lurie Cancer Center website.

Northwestern’s neurology and neurological surgery program is ranked as 7th in the country on the U.S. News & World Report 2013-14 Best Hospitals specialty rankings and 1st in Chicago. This is the seventh consecutive year that Northwestern is the highest ranked neurological program in Illinois and Chicago. The departments of neurology and neurological surgery provide treatment for a full range of neurological disorders and offer patients the latest and most sophisticated treatment and surgical options. Our neurologists and neurosurgeons are actively engaged in clinical research to advance new therapies and uncover the causes and cures of neurological diseases.

Source: PR Newswire

EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, recently announced its commitment to the field of cancer immunotherapy by creating a fully dedicated immuno-oncology innovation platform integrating research, early development and biomarker strategies. In addition to the company’s existing oncology platform, this new immuno-oncology platform will focus on developing therapies that leverage the immune system’s natural ability to fight tumors, and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing that the complexity of cancer requires diverse approaches that will enable alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In order to spur research and early development in this specialized area, we have created an innovative environment where researchers and clinicians work side-by-side to advance potential new cancer immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of which is focused on discovery research and the advancement of molecules into the clinic through proof of confidence:

  • Therapeutic cancer vaccines: targeting tumor antigens to elicit a tumor-specific immune response
  • Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor formation and inhibit metastases
  • Immunotolerance: eliminating or circumventing inhibitory mechanisms in the immune system that prevent cancer cells from being recognized and attacked by the body

To ensure a broad immuno-oncology research and early development platform, EMD Serono has assembled an in-house team of preeminent researchers and clinicians who will focus resources and technologies to build a portfolio of investigational immunotherapies, while collaborating with premier academia, research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a robust pipeline of pre-clinical molecules. Leading therapeutic concepts in the clinic are:

  • A monoclonal antibody targeting PD-L1 (programmed cell death ligand) expressed by various tumors, currently in Phase I in solid tumors
  • NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions of tumors, sponsored by the United States National Cancer Institute (NCI), currently in Phase I in solid tumors
  • NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with other therapeutic modalities, understanding that attacking multiple cancer targets simultaneously increases the possibility of therapeutic success,” said Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, more importantly, by keeping patient needs at the heart of our efforts.”

Source: EMD Serono

med fusion and Theranostics Health Release Novel Cancer Theranostic Test

med fusion and Theranostics Health will introduce the first of the TheraLink™Assays for use in patients with malignant diseases at the American Society of Clinical Oncology (ASCO) Annual ’13 Meeting, held in Chicago, IL from May 31, 2013 through June 4, 2013. The TheraLink™ HER Family Assay for primary, recurrent and metastatic breast cancers provides a molecular analysis of each patient’s unique cancer, based upon the functional activity of signal transduction pathways known to modulate cancerous growth. This ‘theranostic’ assay provides a comprehensive molecular profile of the HER family of cell surface receptors and three key signaling pathways modulated by the HER family which have important roles in the therapeutic approach to treating breast cancer. The TheraLink™ HER Family Assay is the first in a series of similar assays based upon measuring a panel of analytes, including a number of drug targets.

med fusion and Theranostics Health will also announce that they are entering into an exclusive distribution agreement for Theranostics Health’s TheraLink™ HER Family Assay. Under the terms of the agreement, med fusion and its affiliate, Pathologists Bio-Medical Laboratories (PBM), will provide a gateway for access to the theranostic test for the McKesson Network of oncologists, which includes US Oncology and Texas Oncology and to the oncologists of the Baylor Healthcare System. Oncologists will be able to order the assay through their pathology services directly from med fusion.

The TheraLink™ HER Family Assay measures the total amount and activation (phosphorylation) status of 14 critical proteins, receptors and signaling pathway members, providing actionable information for ten currently marketed therapeutics. Starting with a few histopathology sections taken from a core needle biopsy or open resection, the assay is a reverse-phase immunoassay that leverages the extreme sensitivity and precision of microarray technologies to measure these very low abundance proteins, with analyte-specific quantitation provided by on-array calibration samples along with positive and negative controls. The assay provides oncologists with actionable information on drug targets, directly linking active drug targets and the available therapies to identify the most effective personalized treatment options.

“We believe med fusion provides Theranostics Health with a unique opportunity to advance the use of the TheraLink™ Assays,” says Glenn Hoke , President and CEO of Theranostics Health. “Through relationships with their founders, including the McKesson family of health care companies and the Baylor Healthcare System, med fusion provides Theranostics Health with a strong marketing and distribution partner to ensure these assays find utility in the clinical setting.”

“Signal pathway analysis provides some of the most relevant information for targeting cancer therapies,” says Gary L. Smith , Ph.D., Interim CEO and Chief Operating Officer of med fusion. “Furthermore, our collaboration with Theranostics and PBM continues to support med fusion’s model of developing and creating strategic alliances that expand our offering of personalized diagnostic testing services within a patient-centric model of care delivery.”

Source: PR Newswire