Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial; AstraZeneca and Isis Pharma to Co-Develop Targeted Oligonucleotide Delivery Methods Print E-mail
By William Kent   
Thursday, 13 November 2014 20:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 13, 2014.
Chimerix, Inc. (NASDAQ: CMRX), announced its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.

With funding provided by the Wellcome Trust, the trial will be led by the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), with operational support in west Africa provided by Medecins Sans Frontieres (MSF). The World Health Organization (WHO) and local health authorities are also participating in this clinical research. The west African trials will require the review and authorization of local health ministers and ethics boards prior to commencement.

"During what is perhaps the greatest acute public health crisis of our lifetimes, we want to recognize the profound sense of urgency and myriad scientific, medical, and clinical development issues being addressed together with multiple federal and international partners. We look forward to finalizing the trial arrangements with ISARIC as soon as possible to allow a better understanding of the potential benefit that brincidofovir could have in this Ebola Virus Disease outbreak," said M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix.

In October, the U.S. Food and Drug Administration (FDA) authorized a Phase 2 (Study 205) single-arm study to evaluate the safety and antiviral activity of brincidofovir in subjects with confirmed Ebola Virus Disease.



Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
and AstraZeneca announced a strategic alliance to discover and develop novel delivery methods for antisense oligonucleotides. The new delivery approaches seek to target the desired tissue more effectively. The agreement builds on an existing collaboration between AstraZeneca and Isis Pharmaceuticals, a leader in the field of antisense, and supports AstraZeneca's research and development capabilities in the area of antisense oligonucleotide-based therapeutics and RNA biology. Initial project areas will be oncology and cardiovascular and metabolic diseases (CVMD).

Antisense oligonucleotides are short, single strands of DNA or RNA molecules. Rather than modulating the activity of already-formed proteins, antisense oligonucleotides act before proteins are produced at the level of messenger RNA in the cell, thus opening up new opportunities for therapeutic intervention. The new delivery methods will aim to enhance the access of antisense oligonucleotides into specific organs and cells. The methods build on Isis Pharmaceuticals' successful Ligand Conjugation Antisense (LICA) technology. The first example of this technology being Isis' GalNac-conjugated antisense oligonucleotides targeting liver hepatocytes, which lowers the therapeutic dose needed for liver targets by approximately 10-fold.

Under the terms of the agreement, each party will fund its own contribution and commit investigators to the collaboration. In line with AstraZeneca's open innovation approach, the companies will work together on an agreed programme and share rights to the results. Isis can apply learnings from this collaboration broadly across its antisense technology platform and AstraZeneca can similarly apply learnings across its broader RNA-based, small molecule and antibody research and development activities.

Isis Pharmaceuticals and AstraZeneca entered into a collaboration, development and license agreement in 2012 in oncology, subsequently expanded in 2013 to include CVMD. Under the 2012 agreement, one of the molecules being developed is AZD9150 (ISIS-STAT3Rx), a first-in-human, first-in-class, antisense oligonucleotide inhibitor of STAT3, which is being developed as an immunomodulatory agent in combination with MEDI4736, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor. A second product of that collaboration, an antisense oncology compound targeting the androgen receptor AZD5312 (ISIS-ARRx), is in Phase I trials. The new delivery collaboration announced today builds on this existing relationship and is expected to also bring benefits to these programs.

"This exciting collaboration very much supports AstraZeneca's research and development in the area of RNA-based therapeutics. If successful, we'll have a way to selectivity modulate therapeutic targets in specific cell types that are intractable to small molecules and antibodies. This could lead to a number of ground breaking drugs for both oncology and cardiovascular and metabolic diseases," said Susan Galbraith, Head of the Oncology Innovative Medicines Unit, AstraZeneca.

Brett Monia, Senior Vice President of Antisense Drug Discovery, Isis Pharmaceuticals said, "The collaboration expansion announced today builds upon an already successful agreement between Isis and AstraZeneca. Together, we have advanced ISIS-STAT3Rx and ISIS-ARRx in clinical development, both of which are being evaluated in patients with cancer. This opportunity also complements our internal efforts to expand the use of our technology and develop drugs with broad therapeutic applicability."

"RNA molecules play an increasingly important role in our research portfolio. We are delighted to be expanding our existing, strong collaboration with Isis Pharmaceuticals, who are leading players in RNA biology, with the aim of improving the delivery of antisense oligonucleotides to specific cardiovascular and metabolic tissue targets," said Marcus Schindler, Head of the CVMD Innovative Medicines Unit, AstraZeneca.

Also Thursday:

Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported financial results for the quarter ended September 30, 2014.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will present a general corporate overview at the Therapeutic Area Partnerships (TAP) meeting scheduled to take place November 19-21, 2014 in Boston, MA.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced the appointment of Philippe Van Holle to the company's board of directors.

Avalanche Biotechnologies, Inc. (Nasdaq:AAVL)
, a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced that Linda C. Bain, Chief Financial Officer, will present at the Jefferies Global Healthcare Conference on Thursday, November 20, 2014 at 8:40 am GMT in London, England.

Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the Company has filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.

BGMedicine, Inc. (Nasdaq:BGMD)
, the developer of the BGM Galectin-3®Test, today reported financial results for the third quarter 2014.

Cancer Genetics, Inc., (Nasdaq:CGIX)
an emerging leader in DNA-based cancer diagnostics, announced today that the company's CEO, Panna Sharma, will present at the upcoming Canaccord Genuity Medical Technology & Diagnostics Conference.

Capstone Therapeutics (OTCQB:CAPS)
, today will hold a conference call and webcast to provide an operating update and announced financial results for the third quarter 2014.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that Nathan Harding, chief executive officer and co-founder, will present at the Canaccord Genuity Medical Technologies and Device Forum 2014 on Thursday, November 20th at 3:30pm Eastern time in New York.

Enzymotec Ltd. (Nasdaq:ENZY),
a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today reported its financial results for the third quarter ended September 30, 2014.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the Stifel 2014 Healthcare Conference.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, announced it will exhibit its life science equipment and instruments at the Society for Neuroscience 2014 Annual Meeting at the Walter E. Washington Convention Center in Washington, DC on November 16-19 in four separate booths.

Immune Design Corp. (Nasdaq:IMDZ)
, a clinical-stage immunotherapy company, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design, will present at the Jefferies 2014 Global Healthcare Conference in London on November 19, 2014 at 11:20 a.m. GMT/3:20 a.m. PST.

India Globalization Capital, Inc. (NYSE MKT:IGC)
announced financial results for the quarter ended September 30, 2014.

Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the homecare setting, today announced it was included on Deloitte's Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. Inogen grew revenue 605% between 2009 and 2013.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced the controlled market release of the Integra® Expandable Interbody System, in the United States.

Intuitive Surgical (Nasdaq:ISRG)
has awarded technology grants to five top U.S. medical centers to increase training opportunities in minimally invasive surgical techniques. Dartmouth-Hitchcock Medical Center, Duke University, Oregon Health & Science University (OHSU), University of Texas Southwestern and Washington University School of Medicine in St. Louis will each receive a da Vinci System console and Skills Simulator™ equipment for one year.

Minerva Neurosciences, Inc. (Nasdaq:NERV)
, a leader in the development of new therapies to treat neuropsychiatric diseases and disorders, today announced that Remy Luthringer, PhD, president and chief scientific officer at Minerva, will present a review of company pipeline research in a panel discussion at the CNS Summit meeting being held at the Boca Raton Resort and Club in Boca Raton, Florida, November 13-16, 2014.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced today that Stanley C. Erck, President and CEO, will present at the Jefferies Global Healthcare Conference to be held on Thursday, November 20, 2014 at 9:20 a.m. U.S. EST (2:20 p.m. GMT) at the Waldorf Hilton Hotel in London, UK.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced its consolidated financial results and business progress for the third quarter ended September 30, 2014.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an overview of its three clinical development programs and financial results for the quarter ended September 30, 2014.

T2 Biosystems, Inc. (Nasdaq:TTOO)
today announced that John McDonough, president and chief executive officer, is scheduled to present at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 20, 2014, at 10:00 a.m. E.T. in New York City.

VBL Therapeutics (Nasdaq:VBLT)
, a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases, today reported third quarter 2014 financial results.

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