On April 8, 2014 Janssen Research & Development reported the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc (Press release Johnson & Johnson, APR 8, 2014, View Source [SID:1234500380]). This regulatory submission is based on data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL). IMBRUVICA is being jointly developed and commercialized by Janssen and Pharmacyclics.
In February 2014, IMBRUVICA received FDA approval to treat patients with CLL who have received at least one prior therapy. This indication is based on an overall response rate (ORR) from Phase 2 data and an improvement in survival or disease-related symptoms has not been established. The current approval was granted under the FDA’s Accelerated Approval regulations and required the completion of an additional, larger Phase 3 trial to verify clinical benefit.
The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study, which compares once-daily oral IMBRUVICA versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial). Data from this study were accepted and will be presented at the upcoming 50th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

On April 7, 2014 CANCER RESEARCH TECHNOLOGY (CRT), the commercial arm of Cancer Research UK reported a successful outcome to their existing collaboration with Teva through the identification of a novel atypical Protein Kinase C (aPKC) inhibitor pre-clinical candidate, licensed by Teva (Press release, Cancer Research Technology, APR 7, 2014, View Source [SID1234523227]).

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The successful multi-year, cross-discipline, collaboration between CRT and Teva has produced a first-in-class, highly selective and orally-active pre-clinical candidate* inhibitor for development by Teva into possible new drug therapies for cancer patients.

The drug compound blocks the atypical class of Protein Kinase C (PKC) proteins that are differentially activated in defined subsets of cancer patients. The aPKC inhibitor pre-clinical candidate was discovered following lead optimisation of early stage compounds identified within the CRT Discovery Laboratories. Teva provided significant resource and expertise during the collaborative research term to boost existing investment by Cancer Research UK.

The aPKC isoforms PKC iota and PKC zeta are types of enzymes called serine/threonine kinases that have a key role in regulating the formation of tumours (tumourigenesis), the early steps of tumor invasion and metastasis (tumor spread) to distant tissues, and the expansion and growth of cancer stem cells, which contribute to the emergence of tumor resistance to a variety of standard cancer therapies. Inhibition of the aPKC isoenzymes is an attractive target for anti-tumour treatments. Professors Peter Parker and Neil McDonald, at Cancer Research UK’s London Research Institute, significantly contributed to understanding the structural biology of the aPKC drug targets and their validation as important players in cancer cell growth and spread.

"The fruits of this collaboration are significant. These aPKC targets may play a role in a pathway that leads to the formation and progression of cancer. The ability to inhibit this pathway may provide a new approach to the treatment of multiple cancer types in a number of different patient populations", said Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer.

Under the terms of the license, CRT receive an upfront payment, and will be eligible to receive future success-based development milestone payments and royalty payments upon reaching specified targets once the drug is marketed.

Dr Keith Blundy, Cancer Research Technology’s chief executive officer, said: "This successful outcome from our collaboration represents the pinnacle of a highly productive collaboration to discover and develop first-in-class inhibitors of aPKC.

"By working with our industry partner, Teva and academic collaborators, we’ve accessed a much wider range of specialist expertise and experience, and demonstrated our ability to execute successfully the development of novel inhibitors.

"This approach has allowed us to move fast on this project, ahead of other commercial and academic groups interested in developing atypical PKC inhibitors."

On April 7, 2014 Roche and Oryzon Genomics reported they have entered into a worldwide collaboration to research, develop and commercialize inhibitors of Lysine Specific Demethylase-1 (LSD1; KDM1A), an epigenetic modulator that regulates gene expression (Press release Oryzon, APR 7, 2014, View Source [SID:1234500879]).
The lead molecule, ORY-1001, was granted orphan drug status by EMA in August 2013 and is currently in phase I/IIA for acute myeloid leukaemia (AML). Roche will have sole responsibility for developing and commercializing ORY-1001 and/or its backup compounds. The agreement includes the licensing of two patent families that Oryzon has created in its pioneering research in LSD1, and includes options for other Oryzon programs to be incorporated in future. The agreement also includes an initial two-year collaborative research program between Oryzon and Roche’s New York-based Translational Clinical Research Center (TCRC), Roche’s hub for research and early development activities in North America, to better understand the potential of LSD1 inhibitors in oncology and haematology.
John Reed, Roche’s Head of Pharma Research and Early Development, commented, "Oryzon is working at the leading edge of LSD1 inhibition, a technology with great potential to bring genuine patient benefit. Our TCRC in New York has been launched with a mandate to identify partnerships that drive innovation, providing an industryleading conduit between sources of breakthrough science and the broader Roche organization. This collaboration on LSD1 inhibition with Oryzon fulfils that mandate perfectly."
Carlos Buesa, CEO of Oryzon, added, "We are excited to work with Roche in developing ORY-1001 to make a significant difference for patients with AML and, hopefully, for patients in other disease areas as well. Roche is the global leader in oncology and haematology, with a tremendous expertise in clinical development; this was the primary reason to prioritize this alliance. The collaboration is recognition of our cutting-edge science and our experience in epigenetics, an approach that we believe holds great promise for many patient groups."
Under the terms of the agreement, Oryzon will receive an upfront payment and near-term milestones totalling $21 million, plus potential development, commercial and sales milestone payments across haematology, cancer and non-malignant indications that could exceed $500 million, together with tiered royalties on sales which range up to mid-double digits.

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(Press release Lion Biotechnologies, APR 7, 2014, View Source [SID:1234501577])

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Theratechnologies has filed a 20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release Theratechnologies, APR 7, 2014, View Source [SID1234500375]).

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