On July 29, 2014 ImmuNext reported that it has extended and expanded its collaboration with Janssen Biotech, Inc., focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer (Press release ImmuNext, JUL 29, 2014, http://immunext.com/news.php [SID:1234500870]).

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ImmuNext has extended its collaborative effort with Janssen to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. VISTA is a novel negative checkpoint regulator. Janssen will be responsible for clinical development and commercialization of all products under the agreement.

In addition, ImmuNext has expanded the collaboration with Janssen to now include discovery of new targets for modulation of the immune system for the treatment of cancer.

"We have made great progress in our collaboration with Janssen, a global leader in the field of oncology, and we look forward to continuing our collaborative efforts to develop innovative immunotherapies to improve the lives of cancer patients," commented David DeLucia, ImmuNext’s chief executive officer.

On July 28, 2014 AstraZeneca reported that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA (Press release AstraZeneca, JUL 28, 2014, View Source;diagnostic-collaboration-cbrs-layout-1 [SID:1234501057]).

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IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with IRESSA, through a blood test. Currently the main method of assessing EGFR mutation status involves the collection of tumour tissue by needle biopsy or during resection.

QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.

This collaboration is part of a long standing relationship between AstraZeneca and QIAGEN. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

"We are excited about this new partnership with AstraZeneca", said Peer M. Schatz, CEO of QIAGEN. "Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option."

MorphoSys has prioritized presenting first clinical data from the NHL trial at a major conference later this year, earlier than previously anticipated (Press release MorphoSys, JUL 28, 2014, View Source [SID:1234500655]).. In the trial, four different subtypes of NHL, namely follicular lymphoma (FL), mantle cell lymphoma (MCL), diffuse large B cell lymphoma (DLBCL) and other indolent NHL types are investigated. Recruitment in B-ALL has recently been slower than originally anticipated, but enrollment is nevertheless planned to be completed by the end of 2014. For this reason, MorphoSys does not expect to present clinical data for B-ALL in 2014.

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On July 28, 2014 Stemline Therapeutics reported the opening of its SL-401 Investigational New Drug (IND) and initiation of a broad clinical development program including trials in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML) (Press release Stemline Therapeutics, JUL 28, 2014, View Source [SID:1234500657]). SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of many hematologic cancers. SL-401 has completed a physician-sponsored Phase 1/2 trial and demonstrated a tolerable safety profile and clinical activity in multiple indications, including durable complete responses (CRs), in BPDCN and relapsed/refractory AML. Seven of nine evaluable BPDCN patients had objective responses, including 5 CRs. Stemline has now initiated a corporate-sponsored multicenter, open-label trial in patients with BPDCN and relapsed/refractory AML. This study is designed to accrue at least 60 patients, including a brief lead-in that transitions into a larger expansion stage in these indications. Additional trials in other IL-3R expressing malignancies will follow this year and into early next year.

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Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development, commented, "We’re extremely excited to officially kick off our broad clinical development program for SL-401. We’ve already witnessed significant single-agent clinical activity and a wealth of safety data in over 80 patients in a previous physician-sponsored Phase 1/2 trial. We’ve designed our initial corporate-sponsored SL-401 trial to serve as the basis for potential accelerated approval in BPDCN." Dr. Rowinsky continued, "We also expect to initiate other open-label trials this year in additional rare IL-3R+ cancers of unmet medical need including mastocytosis, hypereosinophilic syndrome, myelofibrosis, and chronic myelomonocytic leukemia, which are myeloproliferative disorders that derive from a common IL-3R+ progenitor cell. Here, too, we’ve designed these studies to form the basis of potential accelerated approval in any one, or more, of these indications. We also intend to initiate other studies over the coming months in AML first line (in 1st CR with minimal residual disease positivity), relapsed/refractory myeloma, relapsed/refractory hairy cell leukemia, and other hematologic cancers known to express high levels of IL-3R. We expect to provide specifics around these programs and potential clinical updates on our ongoing open-label trials as the year progresses."

(Press release, CanTx, JUL 25, 2014, View Source [SID:1234505850])

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