Avanir has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On December 9, 2014 Ignyta reported that the World Health Organization (WHO) has approved the international nonproprietary name (INN) "entrectinib" for the company’s lead product candidate, RXDX-101 (Press release Ignyta, DEC 9, 2014, View Source [SID:1234501138]). INNs facilitate the identification of active pharmaceutical ingredients, and each INN is a globally recognized unique name.

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About Entrectinib (formerly RXDX-101)

As a novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins, entrectinib is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK. Entrectinib has demonstrated in vivo antitumor activity against various TrkA, ROS1 or ALK-driven mouse xenograft models of different human cancers, and has demonstrated oral bioavailability and been observed to efficiently cross the blood brain barrier in three animal species.

Entrectinib is currently in two Phase I/II clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial. The company presented interim results from the ALKA-372-001 study in September 2014 at the ESMO (Free ESMO Whitepaper) annual meeting. The interim findings at such date showed:

No dose-limiting toxicities were observed, and only one Grade 3 or higher possibly drug-related adverse event was observed (Grade 3 fatigue, which subsided with dose reduction);
Eight patients remained on active treatment across the three dosing schedules, with four patients having received 9 to 21 cycles of treatment;
Entrectinib demonstrated a complete response in a patient with ROS1-positive non-small cell lung cancer (NSCLC);
Entrectinib demonstrated five partial responses, in patients with three different cancer histologies (colorectal cancer, NSCLC and neuroblastoma) and in patients with each of TrkA, ROS1 and ALK alterations; and
Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.

On December 8, 2014 iTeos Therapeutics SA reported a strategic collaboration with Pfizer Inc. pursuant to which iTeos will license to Pfizer rights to iTeos’ pre-clinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2) (Press release, iTeos Therapeutics, DEC 8, 2014, View Source [SID:1234512318]). Pfizer will be responsible for the development and commercialization of IDO1 and TDO2 drug candidates. Additionally, the parties will collaborate to discover and validate new targets that play key roles in the ability of tumors to evade immune responses. These new targets will be shared by iTeos and Pfizer for further independent or collaborative development.

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"This strategic collaboration is a transformative opportunity for iTeos," said Michel Detheux, Ph.D., chief executive officer of iTeos. "The oncologic expertise of Pfizer will help enable the acceleration and expansion of the scope of iTeos’ IDO1 and TDO2 programs. Furthermore, by working with Pfizer, we aim to produce a series of new targets that have the potential to be further developed by iTeos or Pfizer. This expansion of our drug discovery programs is expected to provide additional, novel immunomodulators for future treatment of cancer patients. The successful integration of Ludwig Cancer Research science into iTeos’ preclinical discovery platform in just two years following inception of the company made this collaboration possible."

"This collaboration with iTeos is another important step for Pfizer as we continue to build an industry-leading pipeline of cancer immunotherapeutics, a critical facet of which is the promising class of small molecule immunomodulators," said Robert Abraham, Ph.D., Senior Vice President and Chief Scientific Officer, Oncology Research Unit, Pfizer. "With iTeos’ strong expertise and experience in tumor immunology, this collaboration is well-positioned to help us deliver on our commitment to help bring new therapies to patients."

iTeos will receive from Pfizer an up-front payment of € 24 million, plus an equity investment, licensing fees and collaborative funding. Further, iTeos will be eligible to earn potential milestone payments from Pfizer based on the achievement of specific development, regulatory and commercial milestones across the IDO1 and TDO2 programs, in addition to royalties on sales. iTeos also has the opportunity to earn additional milestone and royalty payments for any of the new target programs that are advanced by Pfizer.

About IDO1 and TDO2

Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2) are enzymes that break down the amino acid tryptophan. They are expressed in many cancers. Their elevated expression in tumors locally degrades tryptophan, blunting tumor surveillance by the immune system and as such preventing tumor rejection. Specific inhibitors for each enzyme might permit the treatment of a wider variety of tumors, which often express only one of the two enzymes. In tumors that express both enzymes, the combined use of IDO1 and TDO2 inhibitors could reveal complementary benefit for personalized cancer therapy.

On December 4, 2014 Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that the mechanism of action of OncoHist in acute myeloid leukemia (AML) will be the subject of a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 56th ASH (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Xenetic Biosciences, DEC 4, 2014, View Source [SID1234537816]). The meeting is being held December 6-9, 2014 in San Francisco and the poster presentation will be from 6:00 p.m. to-8:00 p.m. local time on December 8. The abstract, available here, also will be published in Blood on December 5.

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Researchers from Dana-Farber Cancer Institute (DFCI), one of the world’s leading cancer institutes, will be presenting the abstract, entitled "OncoHist, an rh Histone 1.3 is cytotoxic to acute myeloid leukemia cells and results in altered downstream signaling (Suiyang Liu, Surender Kharbanda and Richard Stone)." The researchers conclude that their findings support the development of OncoHist alone and in combination with chemotherapy for the treatment of AML. Richard M. Stone, M.D., will present the poster. He is Director of the Adult Acute Leukemia Program at Dana-Farber, Professor, Department of Medicine, Harvard Medical School and, serves on the Medical Oncology Board of the American Board of Internal Medicine, and is Chair, Alliance Leukemia Committee. In February 2013, Xenetic Biosciences signed a broad research agreement for OncoHist with Dana-Farber.

"We are very encouraged by the conclusions of the Dana-Farber researchers and are planning a Phase 1 study with OncoHist in conjunction with Dana-Farber Cancer Institute ultimately to support a New Drug Application filing with the U.S. Food and Drug Administration," said M. Scott Maguire, chief executive officer of Xenetic Biosciences. "Dr. Stone and his colleagues have noted in their preclinical research that OncoHist inhibits and induces necrosis of a number of AML cell lines. We believe this research validates the continuation of the Phase 1/2 trial with OncoHist in combination with cytarabine for the treatment of AML in refractory patients, which is underway in Russia by our partner Pharmsynthez. We look forward to filing our Investigational New Drug application with the FDA during the first half of 2015 and to beginning testing OncoHist in the U.S. for the treatment of AML," added Mr. Maguire.

About OncoHist

OncoHist is a novel patent-protected platform technology that utilizes the special properties of human histone H1.3 for the development of a broad range of cancer indications. OncoHist is based on a molecule occurring naturally in the human cell nucleus, and is therefore expected to be less toxic and immunogenic than other oncology therapies. OncoHist has strong anti-proliferative properties in cancer cells of different histological origins, including hematologic malignancies such as leukemias, lymphomas and myelomas. OncoHist also has the potential to be broadly applied across a spectrum of other cancers.

About Dana Farber Cancer Institute

Dana-Farber Cancer Institute is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute. It provides adult cancer care with Brigham and Women’s Hospital as Dana-Farber/Brigham and Women’s Cancer Center and it provides pediatric care with Boston Children’s Hospital as Dana-Farber/Children’s Hospital Cancer Center. Dana-Farber is the top ranked cancer center in New England, according to U.S. News & World Report, and one of the largest recipients among independent hospitals of National Cancer Institute and National Institutes of Health grant funding. Follow Dana-Farber on Twitter: @danafarber or Facebook: facebook.com/danafarbercancerinstitute.

On December 3, 2014 Array BioPharma reported that it has reached a definitive agreement with Novartis International Pharmaceutical Ltd. to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials (Press release Array BioPharma, DEC 3, 2014, View Source;p=RssLanding&cat=news&id=1994724 [SID:1234501062]). This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected in the first half of 2015, and remain subject to regulatory approval. Array had previously granted Novartis worldwide exclusive rights to develop and commercialize binimetinib under a 2010 License Agreement, which will terminate and be superseded by a new set of agreements between the parties.

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"Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array," said Ron Squarer, Chief Executive Officer, Array BioPharma. "Binimetinib is currently advancing in three Phase 3 clinical trials and, we expect to file for our first regulatory approval during the first half of 2016. With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients."

Novartis stated, "Binimetinib has demonstrated promising results for cancer patients across several different clinical trials. We are committed to supporting a successful transition to Array."

Upon deal close, Array will receive up to $85 million and Novartis’ global, exclusive license to binimetinib will terminate with all rights reverting to Array. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign to Array patent and other intellectual property rights it owns to the extent relating to binimetinib. All clinical trials involving binimetinib, including the COLUMBUS, NEMO and MILO pivotal trials, will continue to be conducted as currently contemplated.

Novartis will be responsible for continued conduct and funding of the COLUMBUS trial. This obligation will transfer to any future owner of LGX818 (encorafenib). Following deal close, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining fully-burdened full time equivalent (FTE) costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials, Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining fully-burdened FTE costs required to complete these studies.

Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array’s designation.

Novartis also retains binimetinib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib. Novartis will also provide Array continued access to several Novartis pipeline compounds including, but not limited to, LEE011 (CDK 4/6 inhibitor) and BYL719 (a-PI3K inhibitor), for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with binimetinib.