On December 22, 2014 Oncolytics Biotech reported that it has submitted applications for Orphan Designation to the European Medicines Agency ("EMA") for REOLYSIN for the treatment of pancreatic and ovarian cancers (Press release Oncolytics Biotech, DEC 22, 2014, View Source [SID:1234501238]).

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"This is the second jurisdiction in which we have elected to file for Orphan Designation," said Dr. Brad Thompson, President and CEO of Oncolytics. "The EMA serves all 28 member countries of the EU and securing Orphan Designation would help support the future development of REOLYSIN in the region."

The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU, and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition. Following Orphan Designation, sponsors can access a number of incentives including protocol assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: View Source

REOLYSIN is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.

On December 22, 2014 Cancer Research UK, Cancer Research Technology (CRT) and Amgen Inc., reported that they have reached an agreement to take forward Amgen’s experimental immunotherapy treatment, AMG319, into its first trial involving patients with solid tumours, following a successful phase one trial of this drug in leukaemia and lymphoma patients (Press release, Cancer Research Technology, 22 22, 2014, View Source [SID1234523243]).

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The collaboration forms part of Cancer Research UK’s Clinical Development Partnership (CDP) scheme, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents for which pharmaceutical companies do not have the resource to progress through early phase clinical trials.

AMG319 targets an important protein called P13 kinase delta to disable the ‘cloaking device’ that tumours use to evade detection by the immune system.

Studies in mice with solid tumours, part-funded by Cancer Research UK, have shown the ability of this class of drug to mount a response against cancer cells by independently stimulating the immune system but this is the first time it has been trialled in patients with solid tumours.*

Cancer Research UK’s Centre for Drug Development will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with the aim of evaluating the safety and biological effect of AMG319 in patients with head and neck cancer.

Dr Jeremy Haigh, Chief Operating Officer for Amgen’s European R&D Organisation, said: "We fully recognise the value of working with Cancer Research UK in this project. Its distinctive expertise and resources will make a big contribution to our deeper understanding of this area of cancer treatment and wider understanding of AMG319. Cancer Research UK brings more than a century of experience in the prevention, diagnosis and treatment of cancer. "

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We’re pleased that this collaboration will allow patients with a wider variety of cancers to access this promising new immunotherapy treatment, which was originally developed for blood cancer patients. Treatments that train the immune system to recognise and kill cancer cells are showing huge promise, so we look forward to seeing whether this drug could echo those results."

On December 22, 2014 Cancer Research UK, Cancer Research Technology (CRT) and Amgen Inc. reported an agreement to take forward Amgen’s experimental immunotherapy treatment, AMG319, into its first trial involving patients with solid tumours, following a successful phase one trial of this drug in leukaemia and lymphoma patients (Press release, Cancer Research Technology, DEC 22, 2014, View Source [SID1234523214]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The collaboration forms part of Cancer Research UK’s Clinical Development Partnership (CDP) scheme, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents for which pharmaceutical companies do not have the resource to progress through early phase clinical trials.

AMG319 targets an important protein called P13 kinase delta to disable the ‘cloaking device’ that tumours use to evade detection by the immune system.

Studies in mice with solid tumours, part-funded by Cancer Research UK, have shown the ability of this class of drug to mount a response against cancer cells by independently stimulating the immune system but this is the first time it has been trialled in patients with solid tumours.*

Cancer Research UK’s Centre for Drug Development will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with the aim of evaluating the safety and biological effect of AMG319 in patients with head and neck cancer.

Dr Jeremy Haigh, Chief Operating Officer for Amgen’s European R&D Organisation, said: "We fully recognise the value of working with Cancer Research UK in this project. Its distinctive expertise and resources will make a big contribution to our deeper understanding of this area of cancer treatment and wider understanding of AMG319. Cancer Research UK brings more than a century of experience in the prevention, diagnosis and treatment of cancer. "

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We’re pleased that this collaboration will allow patients with a wider variety of cancers to access this promising new immunotherapy treatment, which was originally developed for blood cancer patients. Treatments that train the immune system to recognise and kill cancer cells are showing huge promise, so we look forward to seeing whether this drug could echo those results."

On December 22, 2014 Kite Pharma reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 study of KTE-C19, the Company’s investigational anti-CD19 CAR T cell therapy, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL) (Press release Kite Pharma, DEC 22, 2014, View Source [SID:1234501230]).

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On December 19, 2014 ONO PHARMACEUTICAL and Gilead Sciences reported that the companies have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases (Press release Gilead Sciences, DEC 19, 2014, View Source [SID:1234501243]). Under the terms of the agreement, Gilead will pay ONO an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones. The companies will collaborate jointly on global development of ONO-4059. Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.

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ONO-4059 is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells. ONO has presented preliminary Phase 1 data showing clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) at several scientific conferences. ONO and Gilead plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead’s portfolio.

"We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059," said Gyo Sagara, ONO’s President, Representative Director and Chief Executive Officer. "Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead."

"With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK and BTK," said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. "In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead’s other kinase inhibitors with a goal of achieving more pronounced and more durable response rates. We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible."