It successfully achieved silencing of the IDO gene in human dendritic cells (Press release ReGen Therapeutics, AUG 1, 2014, View Source [SID:1234500857]). This is the first experiments in which human cells were utilized in a manner similar to which will be filed with the US FDA.

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On July 31, 2014 Eisai reported that its U.K. subsidiary Eisai Europe Ltd. has been granted an accelerated review by the European Medicines Agency (EMA) for its in-house developed anticancer agent lenvatinib mesylate ("lenvatinib") in the treatment of radioiodine-refractory differentiated thyroid cancer (Press release Eisai, JUL 30, 2014, View Source [SID:1234500704]).

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The EMA’s accelerated review procedure is granted for new medicines that are expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation. Currently, Eisai is planning to submit applications for marketing authorization in Europe and the U.S. in the second quarter of fiscal 2014. In addition, the first application for marketing authorization of lenvatinib in the world was submitted in Japan in June 2014.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors (VEGFR), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor receptors (FGFR), the platelet-derived growth factor (PDGF) receptor PDGFRα, KIT and RET that are involved in tumor proliferation. This potentially makes lenvatinib a first-in-class treatment, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR. It was granted Orphan Drug Designation for thyroid cancer by the health authorities in Japan, Europe and the U.S.

In Europe alone, over 50,000 cases of thyroid cancer were diagnosed in 2012. Although treatment is possible for most types of thyroid cancer, there remains an unmet need for treatment options once the disease has progressed.

Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families.

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.

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."