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Archives for February 2013

Covance and M2Gen Enter into Alliance to Promote Faster Patient Recruitment in Biomarker-Driven Oncology Trials

Covance Inc. (NYSE: CVD), a leading provider of drug development services, announced today that it has entered into an exclusive alliance and services agreement with M2Gen, a subsidiary of the Moffitt Cancer Center and leader in advancing personalized medicine by using high-quality tissue, clinical data and molecular technology to advance research for personalized cancer treatments. Under the agreement, Covance and M2Gen will work together to offer biopharmaceutical clients the ability to match potential patients for biomarker-driven oncology trials with the right treatment or clinical trial. In addition, Covance will become the preferred provider for M2Gen for DNA/RNA sequencing, gene expression analysis, and genotyping analysis services, which will be conducted at Covance’s genomics laboratory in Seattle, Washington.

M2Gen’s cancer-focused data warehouse, one of the largest of its kind in the world, and related specimen biorepository, links longitudinal clinical, molecular and specimen data from more than 95,000 consented patients from Moffitt Cancer Center and a consortium of 17 hospitals throughout the United States. M2Gen uses a proprietary healthcare informatics platform to support a clinical trial matching program, which can significantly reduce the timeline for identifying suitable participants for enrollment in clinical trials and improve the design of biomarker driven trials.

“Working together, Covance and M2Gen expect to help biopharmaceutical companies accelerate their drug development programs, make better decisions, and improve their efforts to develop targeted therapies for cancer patients,” said Ken Somberg, MD, Chief Medical Officer for Covance and Vice President, Clinical Development Services. “M2Gen’s database is unique in the industry, with clinical data captured and maintained over the cancer patient’s lifetime. This alliance will help us partner with sponsors as the field of personalized medicine continues to evolve, and as we work toward a common goal of bringing new life-saving medicines to patients who need them.”

”M2Gen considers Covance to be an ideal strategic partner with the goal of connecting patients to the best treatment options, including clinical trials, by accelerating the discovery and delivery of personalized medicine,” said Bill Dalton, PhD, MD, President and CEO of M2Gen.

Covance is a leader in clinical oncology and has conducted more than 130 trials across several tumor types in the past five years on behalf of biopharmaceutical sponsors. The alliance with M2Gen will extend Covance’s personalized medicine strategy and reinforce its drug development capabilities in this key therapeutic area.

M2Gen and Moffitt Cancer Center will continue efforts to add new hospitals to their network, further expanding access to clinical data for thousands of consenting cancer patients across the United States.

Source: Covance

NanoString Launches Its First Commercial Diagnostic Product in the European Union and Israel

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and molecular diagnostic products, today announced it has launched its first commercial in vitro diagnostic product, the Prosigna™ Breast Cancer Prognostic Gene Signature Assay for the nCounter® diagnostic system in the European Union (EU) and Israel.

Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna assay provides a subtype classification based on the fundamental biology of an individual’s breast tumor (referred to as intrinsic subtyping), and a prognostic score (referred to as the risk of recurrence, or ROR, score). The ROR score estimates the probability of cancer recurrence by 10 years in post-menopausal women with hormone receptor-positive early-stage breast cancer who have been treated with endocrine therapy alone. The Prosigna assay was validated in two clinical studies with more than 2,400 patient samples and results were presented at the 2011 and 2012 San Antonio Breast Cancer Symposium.

The Prosigna assay requires minimal hands-on time and can be offered through qualified pathology laboratories, empowering oncologists and pathologists to manage the diagnostic evaluation of breast cancer patients locally. The Prosigna assay runs on NanoString’s proprietary nCounter system, which offers a simple, reproducible and cost-effective way to profile hundreds of targets simultaneously with high sensitivity and precision. The nCounter Analysis System is currently available for “Research Use Only” in North America.

“Prosigna provides physicians and their patients access to analytically and clinically validated genomic information that can impact important treatment decisions, without the need to send precious samples to a centralized reference lab that may be overseas,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Our launch in the European Union and Israel marks the beginning of our efforts to market Prosigna globally. This is a significant milestone for NanoString as we launch our commercial diagnostics business and work toward additional regulatory marketing authorizations.”

J. Wayne Cowens, M.D., Chief Medical Officer for NanoString Technologies added: “I would like to extend my heartfelt thanks to the investigators and patients who participated in the two pivotal trials for Prosigna. We look forward to making Prosigna available to the many breast cancer patients in need throughout the European Union and Israel.”

Source: Business Wire

Biomarker May Identify Neuroblastomas with Sensitivity to BET Bromodomain Inhibitors

Neuroblastoma, the most common malignant tumor of early childhood, is frequently associated with the presence of MYCN amplification, a genetic biomarker associated with poor prognosis. Researchers have determined that tumors containing MYCN amplification are sensitive to a new class of drugs, BET bromodomain inhibitors.

The researchers made this discovery in a preclinical study, which was funded in part by a Stand Up To Cancer Innovative Research Grant and was published in Cancer Discovery, a journal of the American Association for Cancer Research.

“BET bromodomain inhibitors are a class of drugs that many researchers are hopeful may offer a new therapeutic option for treating patients with certain cancers,” said Kimberly Stegmaier, M.D., assistant professor of pediatrics in the Department of Hematology/Oncology at Dana-Farber/Children’s Hospital Cancer Center in Boston, Mass. “The challenge has been identifying biomarkers that can help direct clinical translation of these drugs by pinpointing those patients with the highest likelihood of response.”

To identify genetic biomarkers of responsiveness to BET bromodomain inhibitors, Stegmaier and colleagues screened more than 600 cancer cell lines with known genetic characteristics for sensitivity to a prototypical BET bromodomain inhibitor.

Using this high-throughput, cell-based screening process, the researchers found that neuroblastoma cells in which the MYCN gene was amplified were sensitive to BET bromodomain inhibitors.

“Neuroblastoma is a devastating childhood cancer, and only a minority of children with high-risk disease will be cured with currently available treatments,” Stegmaier said. “Prior research has shown that MYCN amplification is common in neuroblastoma, but it has been an elusive drug target.”

To further validate their findings, the researchers tested a BET bromodomain inhibitor, from the laboratory of James E. Bradner, M.D., at the Dana-Farber Cancer Institute, using cultured MYCN-amplified neuroblastoma cell lines and three animal models of MYCN-amplified neuroblastoma. Together, they found that the drug decreased levels of MYCN protein in cultured cells, and that this led to impaired cell growth and cell death. In each animal model, including a mouse model of neuroblastoma that is known to be resistant to many standard therapies, the drug was shown to have anti-tumor effects and to prolong survival.

“My Stand Up To Cancer grant, which focused on modulating difficult drug targets in childhood cancers, was instrumental to us being able to do this exciting work,” Stegmaier said. “These types of studies are generally considered high-risk, particularly because they start with unbiased screening, and they are generally less likely to be supported by traditional sources of funding.”

Study: Targeting MYCN in Neuroblastoma by BET Bromodomain Inhibition

Source: EurekAlert!

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

The Medicines Company and Alnylam Form Strategic Alliance to Develop and Commercialize RNAi Therapeutics Targeting PCSK9 for the Treatment of Hypercholesterolemia

The Medicines Company (Nasdaq: MDCO) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, recently announced that they have formed an exclusive global alliance for the development and commercialization of Alnylam’s ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia.

“This new alliance unites two organizations with a shared culture and commitment to innovation. In my view and past experience, there could be no stronger partner for our ALN-PCS program than The Medicines Company, which has demonstrated industry-wide leadership in the advancement of cardiovascular medicines to patients and remarkable success in its strategy of in-licensing, developing, and commercializing breakthrough products,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “For Alnylam, this new partnership enables the advancement of ALN-PCS, an important program within our ‘Alnylam 5×15’ product development and commercialization strategy focused on RNAi therapeutics directed toward genetically validated targets. We believe that the ALN-PCS program holds great promise for the development of a significant therapeutic option for patients with hypercholesterolemia, and that the unique mechanism of action for ALN-PCS could provide a differentiated and potentially best-in-class strategy for PCSK9 antagonism.”

“Our focus on acute and intensive care medicine has led us to a leadership position with Angiomax® (bivalirudin) and potentially with cangrelor in the management of patients in extreme risk as a consequence of the rupture of their vulnerable coronary artery plaque at and around the time of acute coronary syndromes. Meantime, we have made progress with MDCO-216 (ApoA-1 Milano), a turbocharged form of HDL-C (‘good cholesterol’) which has the potential to modify disease through reverse cholesterol transport,” said Clive Meanwell, M.D., Ph.D., Chairman and Chief Executive Officer of The Medicines Company. “Now, this exciting collaboration with Alnylam – leaders in their field of RNAi – adds a second potentially disease modifying approach and more cutting edge technology to our portfolio. We have seen that PCSK9 gene silencing can substantially reduce LDL-cholesterol in patients and has epidemiological and disease mechanisms studies suggest this can further reduce the risks of the world’s number one killer, coronary artery disease. Clearly we see the complementarity of approaches which increase ‘good cholesterol’ (HDL-C) and decrease ‘bad cholesterol’ (LDL-C). We look forward to working with our colleagues at Alnylam for whom we have the greatest respect and admiration based upon earlier collaborations particularly around Angiomax, which was invented by John Maraganore.”

PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that regulates low-density lipoprotein (LDL) receptor levels on hepatocytes; gain-of-function human mutations in PCSK9 are associated with hypercholesterolemia while loss-of-function mutations are associated with lower levels of LDL cholesterol and a reduced risk of cardiovascular disease. ALN-PCS is a PCSK9 synthesis inhibitor that reduces intracellular and extracellular levels of PCSK9 resulting in lowered plasma levels of LDL-C. MDCO-216 is a naturally occurring variant of a protein found in high-density lipoprotein, or HDL. It is a reverse cholesterol transport agent designed to reduce atherosclerotic plaque burden development and thereby reduce the risk of adverse thrombotic events.

Under this alliance, The Medicines Company and Alnylam intend to collaborate on the advancement of the ALN-PCS program. Alnylam’s ALN-PCS program includes ALN-PCS02 – an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc – a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. The Medicines Company is responsible for leading and funding development from Phase II forward and commercializing the ALN-PCS program if successful. Under the terms of the agreement, The Medicines Company will make an upfront cash payment of $25 million to Alnylam. Alnylam may also receive potential development and commercial milestone payments of up to $180 million. Alnylam will be eligible to receive scaled double-digit royalties on global products sales of ALN-PCS products.

Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C. Results showed that administration of a single intravenous dose of drug, in the absence of concomitant lipid-lowering agents such as statins, resulted in statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of LDL-C of up to 50%. ALN-PCS02 was shown to be generally safe and well tolerated in this study and there were no serious adverse events related to study drug administration. Alnylam has also presented pre-clinical data from its ALN-PCSsc program demonstrating potent knockdown of the PCSK9 target gene with an ED50 of less than 0.3 mg/kg after a single subcutaneous dose.

“Cardiovascular disease remains the leading cause of mortality worldwide, with elevated LDL-C a major modifiable risk factor. New strategies are needed to dramatically and rapidly reduce LDL-C and prevent acute cardiovascular events that result from the rupture of cholesterol rich plaque when patients are at their most vulnerable,” said Daniel J. Rader, M.D., professor of Medicine and chief, Division of Translational Medicine and Human Genetics, at the Perelman School of Medicine at the University of Pennsylvania. “As a key regulator of the LDL receptor, liver-expressed PCSK9 is one of the most important and best validated new targets in molecular medicine for the treatment of hypercholesterolemia. The ALN-PCS data generated to date are very encouraging and I look forward to continued clinical studies that highlight the unique mechanistic approach of PCSK9 synthesis inhibitors.”

Dr. Rader serves as a member of Alnylam’s Scientific Advisory Board and as a consultant on Alnylam’s ALN-PCS program, and Alnylam and Dr. Rader collaborate on research for which Alnylam provides materials.

Source: The Medicines Company