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Quintiles Releases Perspectives on Early Phase Oncology and Hematology Biomarkers

In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles recently announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.

The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug development.

“By identifying a well defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage,” said Philip Breitfeld, M.D., vice president and therapeutic strategy head, Quintiles. “As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates.”

The second report, Biomarkers: Recent Advances in their Application to the Treatment of Hematologic Malignancies, presents a point of view on the value of biomarkers in the early detection and stratification of groups at risk for aggressive disease to improve the overall survival rates associated with late stage diagnosis.

Hematopoietic malignancies, which include a heterogeneous group of diseases such as multiple myeloma, lymphomas and leukemias, are characterized based on the appearance of the cells as well as demonstrating the presence or absence of certain cell surface proteins (Cluster of Differentiation or CD markers), characteristic chromosomal abnormalities, and by the identification of particular genetic mutations.

“While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies,” said Harish Dave, M.D., MBA, vice president, global medical strategy head, hematology and oncology, oncology therapeutic area, Quintiles. “Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers.”

Source: Quintiles

Oxford Cancer Biomarkers Announces Biomarker Discovery Deal with AstraZeneca

Oxford Cancer Biomarkers Ltd (OCB), the UK-based company developing tests that allow medicines to be personalised for the benefit of the cancer patient, recently announced an agreement with AstraZeneca for biomarker discovery, with the potential for further collaboration on validation and development of resulting biomarkers.

OCB will work with an undisclosed AstraZeneca cancer drug to discover biomarkers that have the potential to predict responders and non-responders to the drug. Under the agreement, AstraZeneca has been granted an option to license biomarkers from the programme.

Nick McCooke, CEO of Oxford Cancer Biomarkers, commented: “The discovery and development of biomarkers of drug response is becoming an essential component of cancer drug development and commercialisation. With more targeted treatments being made available for more defined patient populations, the need for companion diagnostics is growing. We are a young company but already making a name for ourselves in the cancer biomarkers space, and we are delighted to be working with AstraZeneca on this important program.”

Andrew Hughes, Vice President of Clinical Oncology at AstraZeneca said: “Identifying the right patients is key for the development of AstraZeneca’s targeted oncology drugs. We are excited to be working with Oxford Cancer Biomarkers to explore how their novel approaches can contribute to our biomarker strategy in the early stages of drug development.”

Oxford Cancer Biomarkers uses its proprietary platform CancerNav® to rapidly generate predictive biomarkers for cancer drugs. It has successfully proven its platform through from biomarker discovery to clinical validation.

The company was founded by Nick La Thangue, Ph.D., Chair of Cancer Biology at Oxford University and David Kerr, CBE, D.Sc., M.D. FMedSci, Professor of Cancer Medicine at Oxford University. Its major investor is Quintiles with whom it also has a strategic relationship
in the biomarker space.

Source: AstraZeneca

Roche and Isis Pharmaceuticals Form Alliance for Huntington’s Disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Isis Pharmaceuticals, Inc (NASDAQ: ISIS) recently announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis’ ASOs and Roche’s proprietary “brain shuttle” program with the objective of increasing the brain penetration of ASOs with systemic administration.

Huntington’s disease is an inherited genetic brain disorder that results in the progressive loss of both mental faculties and physical control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications. Presently, there is no effective treatment or cure for the disease, and current treatments focus on reducing the severity of some disease symptoms.

Initially, research will focus on Isis’ lead drug candidate that blocks production of all forms of the huntingtin (HTT) protein, the protein responsible for HD and thus has the potential to treat all HD patients. Isis is also conducting research into treatments that specifically block production of the disease-causing forms of the HTT protein which has the potential to treat subsets of HD patients. In parallel, Roche will combine its proprietary brain shuttle technology with Isis ASO technology that, if successful, will also allow systemic administration of antisense drugs to treat asymptomatic patients.

Under the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche’s “brain shuttle” program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration.

Commenting on the deal, Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche, said: “Huntington’s is a severely debilitating neurodegenerative disease and a large unmet medical need. Patients experience gradually worsening motor function and psychological disturbances, with a significant shortening of life expectancy after the disease is diagnosed. Treatments are urgently needed, and we believe that the Isis approach in combination with Roche’s brain shuttle represent one of the most advanced programs targeting the cause of HD with the aim of slowing down or halting the progression of this disease.”

Shafique Virani, Global Head Neuroscience, Cardiovascular & Metabolism at Roche Partnering, added: “Central to the partnership is Roche’s brain shuttle program, which we see as highly complementary to Isis’ drug development work. This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

“We are pleased to be working with Roche, a global leader in drug development with significant experience in developing and commercializing drugs to treat neurological diseases. We believe that Roche’s expertise in developing CNS drugs, along with their clinical development experience, will greatly enhance our development efforts for this program and allow us to move forward more rapidly. In addition, by utilizing Roche’s brain shuttle technology with our antisense drug discovery capabilities, we have the potential to significantly improve the therapeutic potential for this program,” said B. Lynne Parshall, Chief Operating Officer of Isis. “By partnering our more complex and nuanced research and development programs earlier in development, like our Huntington’s disease CNS program, we add value and resources with partners that bring unique benefits.”

“We are excited to be working with Roche,” said Frank Bennett, Senior Vice President of Research at Isis. “We believe our mature antisense drug discovery platform is a perfect fit for Roche’s neuroscience franchise, and we anticipate a fruitful collaboration to advance our pre-clinical compounds.”

CHDI Foundation, a non-profit foundation exclusively dedicated to the development of therapies that slow the progression of HD, provided financial and scientific support to Isis’ HD drug discovery program through a development collaboration with Isis. CHDI’s support has enabled Isis to make significant progress in discovering a drug to treat HD. Together Isis and CHDI demonstrated that antisense compounds can be used to inhibit the production of HTT protein in both brain and peripheral tissues, and that the inhibition of normal HTT protein was well tolerated. Over time, CHDI will be reimbursed for its support of Isis’ program out of the milestone payments received by Isis. CHDI will receive $1.5 million associated with the signing of the Roche agreement. CHDI will continue to provide advice to Isis and Roche on the development of antisense drugs to treat patients with HD.

Isis also recognizes the tremendous benefit provided to its HD program by its academic collaborators, Drs. Don Cleveland at the Ludwig Institute, University of California San Diego and David Corey at University of Texas Southwestern. These collaborators have been instrumental in Isis’ early preclinical work demonstrating that antisense drugs can inhibit the HTT protein and produce activity in animal models of disease.

Source: Isis Pharmaceuticals

GE Healthcare Launches its First “Next-Generation” Sequencing Assay

GE Healthcare recently announced that Clarient Diagnostic Services, Inc., a GE Healthcare company, will begin offering a next-generation sequencing assay focused on solid tumor targets for use in clinical trials. This assay will empower researchers to perform prospective and retrospective analysis to better understand which patients will respond to particular therapies, to help stratify patient populations for ongoing clinical trials, and to aid early research efforts.

Molecular Response Launches TargetXTM Platform for Rapid Discovery & Validation of New Oncology Targets

Molecular Response recently announced the launch of its TargetX platform for rapid discovery and validation of new oncology targets. The program provides partners with access to the world’s largest bank of living tumor specimens, matched genomic database, and in vivo/ex vivo patient derived tumor models for validation. The integrated platform enables investigators to do in days what used to take months.

Target discovery and validation in oncology has largely relied on molecular and functional studies performed in cell lines. Recent advances in genomics have now created large databases based on well-characterized tumor tissue, which has enabled direct investigation of patient tumors for novel targets. Following these discoveries, it is routine to perform functional studies in cell line-based systems; however, it is often challenging to find a relevant cell line model and if found, there are often numerous factors which confound biology when using historical cell lines for functional studies. The result can be a process which takes considerable time and does not readily translate to clinical relevance.

“TargetX is the largest scale genomic database matched to living patient-derived tumor models,” said Dr. Mohit Trikha, CSO of Triphase Accelerator and founder of Drug Design Corp. “We plan to access it for our drug pipeline development and biomarker identification; having everything in one place allows us to do in days what used to take months. Additionally, we can now work with living patient derived tumor samples rather than cultured cell lines.”

The platform relies on Molecular Response’s proprietary bank of more than 144,000 patient derived tumor cells, of which nearly 400 tumors have been genomically characterized and databased for target discovery studies. The database is growing, but currently features the following cancer indications: colon carcinoma, NSCLC, melanoma, ovarian carcinoma, prostate cancer and Non-Hodgkins Lymphoma. Upon discovery of a novel target, tumors of interest are immediately implanted into mice to perform functional studies in direct patient derived models–either in vivo or ex vivo. Molecular Response currently has more than 60 such patient derived xenograft models established for in vivo studies.

“We continue to focus on the use of patient derived models, both in vivo and ex vivo, for advancing oncology drug development,” said Thomas Broudy, CSO of Molecular Response. “Everybody would like to perform studies in the patient derived tumor setting starting as early as possible, but without the resource to do so, it’s nearly impossible. TargetX now enables you to do that.”

Molecular Response presented results from the TargetX platform at the AACR meeting; the company has identified a novel kinase target for potential therapeutic development. They investigated prevalence of target overexpression across 7 cancer indications, and identified melanoma as a clinical indication of high interest. Growth characteristics from patient tumors featuring high kinase gene expression vs. low expression were examined to help characterize the role of this target in oncology disease progression. Functional studies in these patient derived models to further validate the novel kinase are ongoing, as is a small molecule and antibody-based therapeutic development program.

Source: Business Wire