AmpliPhi Biosciences to Present at LD Micro 10th Annual Main Event

On November 28, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported that Paul C. Grint, M.D., Chief Executive Officer, will present a company overview at the LD Micro 10th Annual Main Event, on Tuesday, December 5, 2017, at 10:30 a.m. PST (1:30 p.m. EST), in Los Angeles (Press release, AmpliPhi Biosciences, NOV 28, 2017, View Source [SID1234522269]).

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The presentation will be available on the Events and Presentations page in the Investor Relations section of AmpliPhi’s website at www.ampliphibio.com.

Insmed to Present at the Nasdaq 37th Annual Investor Conference

On November 28, 2017 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that Will Lewis, President and Chief Executive Officer of Insmed, will present at the Nasdaq 37th Investor Conference in London on Tuesday, December 5, 2017 at 9:15 a.m. GMT (Press release, Insmed, NOV 28, 2017, View Source [SID1234522273]).

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The presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. The webcast will be archived for a period of 90 days following the conclusion of each live event.

Astellas to Present New Data Exploring Gilteritinib in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients at the 2017 American Society of Hematology Annual Meeting (ASH)

On November 28, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported new data in acute myeloid leukemia (AML) research, including preliminary results from a Phase 1 study of the investigational agent gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML, it will present at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Astellas Pharma US, NOV 28, 2017, View Source [SID1234522270]).

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The wide selection of abstracts showcases the company’s full-scale development program across the FLT3 mutation-positive (FLT3mut+) AML care continuum—from newly-diagnosed to relapsed or refractory patients.

"This research further shows FLT3 mutations are one of the most commonly occurring mutations in AML, and we are pleased to be continuing our commitment to addressing the needs of AML patients," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "Further, we’re pleased to showcase additional data that examines the cost of care as well as healthcare utilization in the current treatment of FLT3mut+ AML."

The following abstract will be presented during an oral presentation session:

Title: Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) (Abstract 722)

Presenter: Keith W. Pratz, M.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Session Date/Time: Monday, December 11, 3:00 p.m. EST
Location: Building B, Level 5, Murphy BR 1-2
In addition to the oral presentation, Astellas will present the following five abstracts during poster sessions:

Title: Treatment Patterns and Healthcare Resource Utilization in Patients with FLT3-mut and FLT3-wt Acute Myeloid Leukemia: A Multi-country Medical Chart Study (Abstract 2186)

Lead Author: James D. Griffin, M.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Comparative Assessment of FLT3 Variant Allele Frequency by Capillary Electrophoresis and Next-Generation Sequencing in FLT3mut+ Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) who Received Gilteritinib Therapy (Abstract 1411)

Lead Author: Catherine C. Smith, M.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Real-World Occurrence of Symptoms and Toxicities and Associated Cost Implications in Acute Myeloid Leukemia (AML) Treatment Episodes: A Retrospective Database Analysis in the U.S. (Abstract 2118)

Lead Author: Bhavik Pandya, Pharm.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Evaluation of the Impact of Minimal Residual Disease, FLT3 Allelic Ratio, and FLT3 Mutation Status on Overall Survival in FLT3 Mutation-Positive Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) in the CHRYSALIS Phase 1/2 Study (Abstract 2705)

Lead Author: Mark J. Levis, M.D., Ph.D.

Session Date/Time: Sunday, December 10, 6:00-8:00 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Economic Burden of Treatment Episodes in Acute Myeloid Leukemia (AML) Patients in the U.S.: A Retrospective Analysis of a Commercial Payer Database (Abstract 4694)

Lead Author: Bruno C. Medeiros, M.D.

Session Date/Time: Monday, December 11, 6:00-8:00 p.m. EST
Location: Building A, Level 1, Hall A2
About Gilteritinib
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of all patients with AML. Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines, which has been reported to be associated with therapeutic resistance. Astellas is currently investigating gilteritinib in various AML patient populations through several Phase 3 trials. Visit AstellasAMLTrials.com to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialize gilteritinib. Gilteritinib has been granted Orphan Drug designation and Fast Track designation by the U.S. FDA, and SAKIGAKE designation by the Japan Ministry of Health, Labor and Welfare.

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development), which is included in this press release are not intended to constitute an advertisement or medical advice.

STORM THERAPEUTICS ANNOUNCES PUBLICATION IN NATURE ON RNA EPIGENETICS BY FOUNDER PROFESSOR TONY KOUZARIDES

On November 27, 2017 STORM Therapeutics, the leading drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported the publication of data in the internationally renowned scientific journal Nature linking an essential RNA-modifying enzyme to acute myeloid leukaemia (AML) (Press release, STORM Therapeutics, NOV 27, 2017, View Source [SID1234561048]).

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The study has found an unexpected new drug target for acute myeloid leukaemia (AML) that could open new avenues to develop effective treatments against this potentially lethal disease. Data show that inhibiting the METTL3 gene destroys human and mouse AML cells without harming nonleukaemic blood cells. The paper, entitled "Promoter-bound METTL3 maintains myeloid leukaemia via m6A-dependent translation control’, goes on to reveal why METTL3 is required for AML cell survival, by deciphering the new mechanism it uses to regulate several other leukaemia genes.

Professor Tony Kouzarides, Founder of STORM Therapeutics and joint project leader from the Gurdon Institute, University of Cambridge, commented: "This is an important milestone in the understanding of RNA epigenetics and its links to disease. These findings highlight the importance of RNA modifying enzymes in cancer, and in particular in leukaemia. New treatments for AML are desperately needed and we have been looking for novel genes that would be good drug targets. We identified the methyl transferase enzyme METTL3 as a highly viable target against AML. Our study will inspire pharmaceutical efforts to find drugs that specifically inhibit METTL3 to treat AML."

STORM has established a pipeline of drug discovery programmes to develop novel, first-in-class drugs for the treatment of specific cancers and other diseases with high unmet medical need. It is focusing on two classes of RNA modifying enzymes, RNA methyltransferases and terminal uridyltransferases (TUTases), and has already advanced two undisclosed targets in drug discovery.

Keith Blundy, CEO of STORM Therapeutics, said: "STORM leads the field of harnessing the power of RNA epigenetics as a new area of important biology. Our ambition is to become a world leading therapeutics company tackling diseases through modulating RNA modifying enzymes. Publication of these data, in such a prestigious journal as Nature, is validation of the world class science on which the Company was founded."

This publication represents results obtained from research conducted in collaboration by: Wellcome Trust Sanger Institute, The Gurdon Institute and Department of Pathology at the University of Cambridge, Cold Spring Harbor Laboratory and STORM Therapeutics.

AstraZeneca and Chinese Future Industry Investment Fund establish joint venture to develop new medicines in China

On November 27, 2017 AstraZeneca reported a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster (Press release, AstraZeneca, NOV 27, 2017, View Source [SID1234537458]). FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

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The new company, Dizal Pharmaceutical, incorporates all scientific and technical capabilities of AstraZeneca’s Innovation Center China (ICC), and holds exclusive rights to develop and commercialise three potential medicines currently in pre-clinical development from AstraZeneca’s pipeline in its main therapy areas of oncology, cardiovascular and metabolic diseases, and respiratory. It is also expected to initiate novel clinical programmes. The FIIF will contribute funding and expertise in establishing strategic partnerships in China.

Dr. Xiaolin Zhang, previously Head of AstraZeneca’s ICC, has been named as Chief Executive Officer of the new company. All staff employed by the ICC have been invited to join the new company.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: "AstraZeneca has a long-standing and strong commitment to China, which we are reinforcing today with this ground-breaking joint venture. By joining forces with the FIIF, we aim to accelerate the local discovery and development of innovative, affordable medicines for patients in China and around the world."

Guohua Gao, Chairman of SDIC Fund, said: "FIIF is delighted to be collaborating with AstraZeneca to promote the development of innovative medicines. AstraZeneca’s Innovation Center China has an excellent track record of drug discovery, and the synergy created by combining AstraZeneca’s scientific talent and assets with FIIF’s China expertise and funding will help further promote innovation in medical science."

The remit of the FIIF in the pharmaceutical industry is to promote the development and manufacturing of innovative medicines in China through strategic partnerships. The joint venture supports AstraZeneca’s commitment to enhancing China’s research and development capabilities through diversified external partnerships that deliver value to patients in China.