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From top to bottom: midkine and pleiotrophin as emerging players in immune regulation.
Sorrelle N1, Dominguez ATA1, Brekken RA2,3.
Author information
1Hamon Center for Therapeutic Oncology Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; and.Hamon Center for Therapeutic Oncology Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; and rolf.brekken@utsouthwestern.edu.Division of Surgical Oncology, Departments of Surgery and Pharmacology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Abstract
Cytokines are pivotal in the generation and resolution of the inflammatory response. The midkine/pleiotrophin (MK/PTN) family of cytokines, composed of just two members, was discovered as heparin-binding neurite outgrowth-promoting factors. Since their discovery, expression of this cytokine family has been reported in a wide array of inflammatory diseases and cancer. In this minireview, we will discuss the emerging appreciation of the functions of the MK/PTN family in the immune system, which include promoting lymphocyte survival, sculpting myeloid cell phenotype, driving immune cell chemotaxis, and maintaining hematopoiesis.
© Society for Leukocyte Biology.
https://www.ncbi.nlm.nih.gov/pubmed/28356350
BREKKEN - 3rd Border Biomedical Research Center Symposium
Health Disparities: From Molecules to Disease
September 17-19, 2017
Tuesday 19 September 2017
6:10 – 6:55 pm Rolf Brekken (Professor, Surgery, Hamon Center for therapeutic Oncology, Pharmacology, UT
“Pathways that drive resistance to anti-VEGF therapy and strategies to overcome them”
https://science.utep.edu/bbrcsymposium/index.php/program
Phosphatidylserine Translocation after Radiosurgery in an Animal Model of Arteriovenous Malformation
http://www.bioone.org/doi/abs/10.1667/RR14646.1
That was my intention
ESMO 2017: Exhibiting Companies
http://www.esmo.org/Conferences/ESMO-2017-Congress/Abstracts
Mouse macrophages show different requirements for phosphatidylserine receptor Tim4 in efferocytosis
Just a mouse
http://m.pnas.org/content/early/2017/08/01/1705365114.abstract
Cladosporol A triggers apoptosis sensitivity by ROS-mediated autophagic flux in human breast cancer cells.
https://www.ncbi.nlm.nih.gov/pubmed/28728544
For you my friend!:
http://precisionlungcancer.com/assets/plc-2017---agenda.pdf
Or this - Novartis:
David Lebwohl, MD
Senior Vice President & Global Program Head, CAR-T Program, Novartis
David Lebwohl, M.D. is Senior Vice President and Executive Global Program Head for the CART Team in the Novartis Cell and Gene Therapy Unit, based in East Hanover, NJ, USA. In this position he leads the development of chimeric antigen receptor T-cell therapies at Novartis.
He was formerly global head of Oncology Clinical Development, and Global Program Head for Afinitor, an oral mTOR inhibitor, within Novartis Oncology. He graduated from Harvard College magna cum laude in Biochemical Sciences and was then a Graduate Research Student in Tumour Immunology at University College London. He graduated as doctor of medicine from the Yale University School of Medicine.
Following post-graduate training at Brigham and Women’s Hospital and Memorial Sloan-Kettering Cancer Center [color=red][/color]in internal medicine, hematology and medical oncology, he joined the staff of Memorial Sloan-Kettering on the Breast Cancer Service. More recently, Dr. Lebwohl has focused on the clinical development of new cancer drugs, first at Bristol Myers Squibb, where he lead the development of JM-216, an oral platinum, and ixabepilone, an epothilone, as well as other compounds. He joined Novartis Oncology in 2002 where he was responsible for the development of Afinitor (RAD001) from phase 1 through five NDA/MAA approvals. He also led the clinical development of PTK787, a VEGFR inhibitor, panobinostat, a deacetylase inhibitor, and PKC412, a FLT3 kinase inhibitor.
Next - Novartis:
Novartis reports 9.7 pct passive stake in Akcea Therapeutics as of July 19 - Reuters Investor Briefs
27-Jul-2017 12:32:44
July 27 (Reuters) - Akcea Therapeutics Inc AKCA.O: *Novartis Pharma AG reports 9.7 percent passive stake in Akcea Therapeutics Inc as of July 19, 2017 - SEC filing
Maybe Novartis is trying to speed up:
Oncology Venture Enters into Option Agreement with Novartis Pharma to License Small Molecule Compound - MarketLine
22-Jul-2017 00:20:05
Oncology Venture AB, a company engaged in the R&D of anti-cancer drugs, has entered into an agreement with Novartis Pharma AG, a pharmaceutical company, providing Oncology Venture with an option right to execute an exclusive license to develop and commercialize an undisclosed small molecule, kinase inhibitor in clinical development. The molecule has been explored in multiple therapeutic indications including a variety of solid tumors. Under the option agreement, Oncology Venture will evaluate whether it can suitably develop and validate a companion diagnostic for the drug using its proprietary DRP biomarker platform. This agreement will enable Oncology Venture and Novartis Pharma to evaluate the potential of a small molecule compound for development in cancer.
This agreement will enable Oncology Venture and Novartis Pharma to evaluate the potential of a small molecule compound for development in cancer.
Deal In Brief
Deal Type Partnership
Sub-Category Licensing Agreement
Deal Status Announced: 2017-07-19
Deal Participants
Partner 1 (Company) Novartis Pharma AG Partner 2 (Company) Oncology Venture Sweden AB
Deal Rationale
Copyright (c) 2001-2016 Marketline.
Increased heterogeneity of brain perfusion is an early marker of central nervous system involvement in antiphospholipid antibody carriers
Published: August 1, 2017
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0182344
That was in April 2017!
Evaluation of tumor oxygenation following radiation and PS-targeting antibody therapy in an orthotopic lung cancer model
Heling Zhou1, Olivier Belzile2, Zhang Zhang3, Debabrata Saha3, Jo Wagner1, Brock Sishc3, Strahinja Stojadinovic3, Rolf Brekken2,4, and Ralph P Mason1
1Radiology, Univ Texas Southwestern Medical Center, Dallas, TX, United States, 2Hamon Center for Therapeutic Oncology Research, Univ Texas Southwestern Medical Center, Dallas, TX, United States, 3Radiation Oncology, Univ Texas Southwestern Medical Center, Dallas, TX, United States, 4Surgery, Univ Texas Southwestern Medical Center, Dallas, TX, United States
Combining phosphatidylserine (PS)-targeting monoclonal antibodies with radiation therapy can potentially enhance treatment efficacy. Oxygenation is important in radiation therapy response and could influence future treatment design. Oxygen enhanced MRI was used to examine changes in oxygenation in orthotopic lung tumors in rats treated by radiation or radiation plus a PS-targeting antibody. Orthotopic tumors were well oxygenated and responsive to oxygen breathing challenges before and after treatment. Combination therapy appeared to be more effective in tumor control than radiation alone.
http://dev.ismrm.org/2017/4364.html
Bayer : Patent Issued for Gla Domains as Targeting Agents (USPTO 9694048)
IS THIS AN OLD ONE? - Rutgers and R. Birge
Differential Phosphatidylserine sensing by TAM receptors regulates AKT dependent chemoresistance and PD-L1 expression in epithelial cells
Canan Kasikara,
Sushil Kumar and
Raymond Birge
-
Author Affiliations
Microbiology, Biochemistry and Molecular Genetics, Rutgers University, Newark, NJ
Abstract
Tyro3, Axl and Mertk (TAMs) are three homologous receptor tyrosine kinases that bind vitamin K-dependent endogenous ligands, Protein S (ProS1) and Growth arrest specific factor 6 Gas6, and act as bridging molecules to promote PS-mediated clearance of apoptotic cells (efferocytosis). In recent years, it has become appreciated that TAMs are overexpressed in a vast array of tumor types, whereby the level of expression correlates with the tumor grade and the emergence of chemo and radio resistance to targeted therapeutics. TAMs have also been implicated as inhibitory receptors on infiltrating myeloid-derived cells in the tumor microenvironment that can suppress anti-tumor immunity. In addition to TAM overexpression, externalized PS is also concomitantly up-regulated in the tumor microenvironment, suggesting a PS/TAM receptor axis operates in the tumor microenvironment. Previously, we developed chimeric TAM reporter cell lines comprised of the extracellular domains of each TAM fused to the intracellular domains of the IFNR1, and reported that each TAM receptor had a unique pattern of activation by Gas6 or ProS1, as well as unique dependency for PS on apoptotic cells and PS liposomes for activity. In the present study, we leveraged this system to engineer epithelial cells that express WT TAMs, and show that while each TAM can promote PS-mediated efferocytosis, AKT-mediated chemo-resistance, as well as up-regulate the immune checkpoint inhibitory ligand PD-L1 on tumor cells, Mertk is most dominant in the aforementioned pathways. Functionally, TAM-mediated efferocytosis could be partially blocked by PS-targeted antibody 11.31 and Annexin V, demonstrating the existing of a PS/PS-R (TAM-receptor)/PD-L1 axis that operates in epithelial cells that may drive immune escape. These studies provide a rationale that anti-PS, anti-TAM, and anti-PD-L1 based therapeutics may have therapeutic merit as combinatorial checkpoint inhibitors.
Support or Funding Information
NIH CA 1650771
New Jersey Health Foundation NJHF pilot grant
Rutgers Foundation grant
http://www.fasebj.org/content/31/1_Supplement/775.10
Targeting phosphatidylserine in combination with adoptive T cell transfer eliminates advanced tumors without off-target toxicities in a melanoma preclinical model
http://cancerres.aacrjournals.org/content/77/13_Supplement/1651
Just one..... and there are many others
PEREGRINE PHARMACEUTICALS INC FILES AMENDED PROXY STATEMENT -- DEFA14A
EDG
07/31/2017 8:07 PM
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20170731:EDG_0001683168-17-001896
nEOL8GfNgH
© Thomson Reuters 2017. All rights reserved.
AstraZeneca hires two immuno-oncology experts - RTRS
31-Jul-2017 14:41
July 31 (Reuters) - AstraZeneca Plc AZN.L:
* ?Jean-Charles Soria joins Medimmune, co's global biologics research and development arm, as senior vice president, head of oncology innovative medicines
Geoffrey Kim appointed head oncology strategic combinations at AstraZeneca?
Peregrine Provides Strategic Update - GlobeNewswire
31-Jul-2017 14:30:06
Plans to Expand Board of Directors to Add CDMO and Biologics Industry
Expertise
Search for a Dedicated President to Head Avid Bioservices CDMO Business to
Commence
Continues to Evaluate Strategic Options for Advancing R&D Business
TUSTIN, Calif., July 31, 2017 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals,
Inc. (Nasdaq:PPHM) today announced that it intends to increase the size of its
Board of Directors from four to up to seven members through the addition of
new highly-qualified independent directors with CDMO and biologics experience.
The Company also announced that it plans to initiate a search for a dedicated
President to lead its wholly-owned CDMO subsidiary, Avid Bioservices, Inc.
Lastly, the Company today provided an update on its evaluation of strategic
options for advancing its R&D business.
Addition of Board Members
“We look forward to adding new directors with valuable CDMO and biologics
industry experience and skills to the Board, broadening our overall expertise
and complementing the capabilities and experience of our current directors,”
said Carlton Johnson, Chairman of Peregrine’s Board of Directors. “The
Board and management will benefit from the additional perspectives provided by
new directors who share our commitment to maximizing stockholder value.”
“The Board has played an important role in supporting the growth of the CDMO
business and has provided the management team with valuable insight and
support over many years. This support was critical in allowing us to build a
successful CDMO business while simultaneously advancing our R&D pipeline,”
said Steven King, President, CEO and Director of Peregrine and President of
Avid Bioservices. “As we continue to evaluate a number of strategic options
to sharpen the focus of each of our two distinct businesses and enhance
shareholder value, I am confident that these planned additions will enhance
our ability to successfully lead the Company through this critical process.”
Search for Dedicated Avid Bioservices President
Peregrine also plans to appoint a new dedicated President to lead Avid and
focus entirely on executing the CDMO business’ growth strategy. The new
President will report directly to Mr. King while the company continues to
evaluate strategic options including potentially separating the R&D and CDMO
businesses. The Company believes that the addition of the new President for
Avid and the addition of board members with CDMO experience will strengthen
Avid’s position for future success regardless of the strategic alternatives
the Company may pursue. Mr. King, who has served as President of Avid since
its formation, will continue to serve in his current role until a candidate is
hired in order to ensure continued high level services for its current
customers and to make sure there is a successful and smooth transition to the
new leadership.
Avid was formed in 2002 to service the attractive commercial bio-manufacturing
market. Over the last 15 years, Avid has become a leader in implementing
disposable bio-manufacturing processes at commercial scale for large molecule
API manufacturing. The Company has achieved a premiere customer list,
excellent regulatory track record and strong competitive position from which
it can capitalize on favorable industry growth trends. In fiscal year 2017,
Avid generated revenues of over $57 million and achieved a five-year
compounded annual revenue growth rate of 31%.
“Avid has experienced remarkable and steady growth over the last several
years, and we are taking steps to ensure that it remains well-positioned to
take advantage of the growing demand for biologics and biosimilar drugs,”
said King. “We have a clear strategic plan and proven track-record in our
CDMO business, as evidenced by our investments in the state-of-the-art Myford
facility, our progress securing new customers and expanding our services
offerings, and our recent record financial results. With the addition of a
new dedicated President, Avid will benefit from a leadership team focused
solely on executing its long-term strategic plan of driving growth,
diversifying its customer base and optimizing its operations and
facilities.”
R&D Business Update
Continued King, “At the same time, we are actively evaluating strategic
options for advancing our R&D business. We are working with researchers at
some of the leading research institutes in the world and have seen renewed and
encouraging interest in the bavituximab program from influential key opinion
leaders. We believe recent promising clinical data from our bavituximab
program, in addition to our other R&D assets, strongly supports continued
advancement of the pipeline with the goal of providing patients with new
cancer treatment options. Leveraging the scientific expertise of key opinion
leaders, we will apply great rigor in assessing additional investments and
identifying the best way to move our R&D programs forward.”
“As we recently noted on our fourth quarter conference call, Peregrine is at
the start of a transformative journey, which includes exploring strategic
alternatives,” said King. “We are focused on enhancing shareholder
returns as we capitalize on long-term opportunities available to Avid and
pursue the optimal path forward for our drug development franchise. The
search for new Board members and a new dedicated leader for Avid mark the
first in a series of planned strategic actions that will strengthen the
position of Avid as a more independent and potentially as a completely
independent entity with a focus on revenue growth and increased
profitability. We will also continue to explore the best strategic
alternatives for the R&D pipeline in order to maximize value for
stockholders.”
Peregrine will be working with a nationally recognized executive search firm
to assist in identifying highly qualified candidates for the Avid President
and Board of Directors positions. The Company intends to appoint a President
to the Avid business in the coming months and include the identified directors
in its slate of nominees for election to the Board at its next Annual Meeting
of Stockholders.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of patients by delivering high quality pharmaceutical
products through its contract development and manufacturing organization
(CDMO) services and through advancing and licensing its investigational
immunotherapy and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are provided
through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com),
which provides development and biomanufacturing services for both Peregrine
and third-party customers. The company is also working to evaluate its lead
immunotherapy candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its proprietary
exosome technology for the detection and monitoring of cancer. For more
information, please visit www.peregrineinc.com.
About Avid Bioservices, Inc.
Avid Bioservices, a wholly owned subsidiary of Peregrine Pharmaceuticals,
provides a comprehensive range of process development, high quality cGMP
clinical and commercial manufacturing services for the biotechnology and
biopharmaceutical industries. With over 20 years of experience producing
monoclonal antibodies and recombinant proteins in batch, fed-batch and
perfusion modes, Avid's services include cGMP clinical and commercial product
manufacturing, purification, bulk packaging, stability testing and regulatory
strategy, submission and support. The company also provides a variety of
process development activities, including cell line development and
optimization, cell culture and feed optimization, analytical methods
development and product characterization. For more information about Avid,
please visit www.avidbio.com.
Forward–Looking Statements
This communication contains statements that relate to future events and
expectations and as such constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include those containing such words as
“anticipates,” “believes,” “could,” “estimates,”
“expects,” “forecasts,” “guidance,” “goal,” “intends,”
“may,” “outlook,” “plans,” “projects,” “seeks,”
“sees,” “should,” “targets,” “will,” “would,” or other
words of similar meaning, including, without limitation, statements regarding
Peregrine’s intent to increase the size of its Board of Directors and add
independent members with CDMO and biologics experience, the company’s intent
to initiate a search for a President to lead its wholly-owned CDMO subsidiary,
Avid Bioservices, Inc., Peregrine’s plans for advancing its R&D business, as
well as the expected timing for the foregoing matters. All statements that
reflect Peregrine’s expectations, assumptions or projections about the
future, other than statements of historical fact, are forward-looking
statements, including, without limitation, statements and guidance regarding
future financial results or operating performance. Forward-looking statements
are not guarantees of future performance and are subject to risks,
uncertainties, and changes in circumstances that are difficult to predict.
Although Peregrine believes that the expectations reflected in any
forward-looking statements are based on reasonable assumptions, it can give no
assurance that these expectations will be attained and it is possible that
actual results may differ materially from those indicated by these
forward-looking statements due to a variety of risks and uncertainties. Such
risks and uncertainties include, but are not limited to the risk factors
discussed in Peregrine’s Form 10-K for the year ended April 30, 2017, and
other reports filed with the U.S. Securities and Exchange Commission (SEC).
Peregrine disclaims any obligation to update publicly any forward-looking
statements, whether in response to new information, future events or
otherwise, except as required by applicable law.
Important Additional Information
Peregrine intends to file a proxy statement with the Securities and Exchange
Commission (SEC) in connection with the solicitation of proxies for
Peregrine’s 2017 Annual Meeting (Proxy Statement) with an associated WHITE
proxy card. Peregrine, its directors and certain of its executive officers
will be participants in the solicitation of proxies from stockholders in
respect of the 2017 Annual Meeting. Information regarding the names of
Peregrine’s directors and executive officers and their respective interests
in Peregrine by security holdings or otherwise is set forth in the Annual
Report on Form 10-K of Peregrine, for the fiscal year ended April 30, 2017,
filed with the SEC on July 14, 2017, and Peregrine’s proxy statement for the
2016 Annual Meeting, filed with the SEC on August 26, 2016. To the extent
holdings of such participants in Peregrine’s securities are not reported, or
have changed since the amounts described, in the 2016 proxy statement, such
changes have been reflected on Initial Statements of Beneficial Ownership on
Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC.
Details concerning the nominees of Peregrine’s Board of Directors for
election at the 2017 Annual Meeting will be included in the Proxy Statement.
BEFORE MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS OF THE COMPANY
ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO THE SEC,
INCLUDING THE COMPANY’S DEFINITIVE PROXY STATEMENT AND ANY SUPPLEMENTS
THERETO, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and
stockholders will be able to obtain a copy of the definitive proxy statement
and other documents filed by Peregrine free of charge from the SEC’s
website, www.sec.gov. Peregrine’s stockholders will also be able to obtain,
without charge, a copy of the definitive Proxy Statement and other relevant
filed documents by directing a request by mail to Peregrine, Corporate
Secretary’s Office, 14282 Franklin Avenue, Tustin, CA 92780, by calling
Peregrine’s proxy solicitor, MacKenzie Partners, Inc., toll-free at (800)
322-2885, or from Peregrine’s website at www.Peregrine.com.
Contacts:
Stephanie Diaz (investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
GlobeNewswire, Inc. 2017
nGNXOCSGFa
(C) Thomson Reuters 2017. All rights reserved.The Thomson Reuters content received through this service is the intellectual property of Thomson Reuters or its third party suppliers. Republication or redistribution of content provided by Thomson Reuters is expressly prohibited without the prior written consent of Thomson Reuters, except where permitted by the terms of the relevant Thomson Reuters service agreement. Neither Thomson Reuters nor its third party suppliers shall be liable for any errors, omissions or delays in content, or for any actions taken in reliance thereon. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
NEWSSSS
ALERTS HISTORY
31-Jul-2017 14:30 - PEREGRINE PROVIDES STRATEGIC UPDATE
31-Jul-2017 14:30 - PEREGRINE PHARMACEUTICALS INC - ?CONTINUES TO EVALUATE STRATEGIC OPTIONS FOR ADVANCING R&D BUSINESS?
31-Jul-2017 14:30 - PEREGRINE PHARMACEUTICALS INC - ?PLANS TO EXPAND BOARD OF DIRECTORS TO ADD CDMO AND BIOLOGICS INDUSTRY EXPERTISE?
31-Jul-2017 14:30 - PEREGRINE PHARMACEUTICALS INC - ?INTENDS TO INCREASE SIZE OF ITS BOARD OF DIRECTORS FROM FOUR TO UP TO SEVEN MEMBERS?
31-Jul-2017 14:30 - PEREGRINE PHARMACEUTICALS INC - ?PLANS TO INITIATE A SEARCH FOR A PRESIDENT TO LEAD ITS WHOLLY-OWNED CDMO SUBSIDIARY, AVID BIOSERVICES, INC?
PEREGRINE PHARMACEUTICALS INC - ?PLANS TO INITIATE A SEARCH FOR A PRESIDENT TO LEAD ITS WHOLLY-OWNED CDMO SUBSIDIARY, AVID BIOSERVICES, INC? - RTRS
Circulating tumor cells and coagulation—Minireview
http://www.croh-online.com/article/S1040-8428(17)30197-X/fulltext
Phosphorylation of lipid metabolic enzymes by yeast protein kinase C requires phosphatidylserine and diacylglycerol
https://www.google.at/url?sa=t&source=web&rct=j&url=http://foodsci.rutgers.edu/carman/PDF%2520Files/Yeast%2520PKC-J.%2520Lipid%2520Res.-2017-Dey-742-51.pdf&ved=0ahUKEwiyj7Stz67VAhWCmBoKHa34Cqo4ChAWCC4wAw&usg=AFQjCNHCtc3FC65h3i-Qpfuxrcf8XKHGqg
ASTRAZENECA AND MERCK ESTABLISH STRATEGIC ONCOLOGY COLLABORATION AZN.L MRK.N
ENPNWS
07/28/2017 12:34 PM
ENPNEWSWIRE-(C)2017 ENPUBLISHING
Release date- 27072017 - Collaboration aims to maximise the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumour types.
AstraZeneca and Merck will independently develop and commercialise Lynparza and potential medicine selumetinib in combinations with companies' respective PD-L1/PD-1 immuno-oncology medicines Imfinzi and Keytruda
Collaboration will significantly expand the potential of Lynparza, the world's first and leading PARP inhibitor, as a backbone of combination treatments for multiple cancer types; agreement also includes AstraZeneca's selumetinib, a MEK inhibitor
The companies will share development and marketing costs equally, as well as gross profits from Lynparza and selumetinib
27 July 2017
AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca's Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
Lynparza's pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumour types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients.
The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi (durvalumab) and Keytruda (pembrolizumab).
The companies will also jointly develop and commercialise AstraZeneca's selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.
Pascal Soriot, Chief Executive Officer of AstraZeneca, said: 'Our strategic collaboration builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumours. By bringing together the expertise of two leading oncology innovators, we will accelerate Lynparza's potential to become the preferred backbone of many immuno-oncology combination therapies as the world's first and leading PARP inhibitor. This is a truly exciting step and we are pleased to work with Merck, a company that shares our passion for science to deliver new medicines for cancer patients.'
Kenneth C. Frazier, Chief Executive Officer of Merck, said: 'This global collaboration between AstraZeneca and Merck, two oncology leaders, will increase the possibilities for patients to have more treatment options for more cancers. Merck continues to build its leadership in immuno-oncology with Keytruda as foundational in monotherapy and combination therapy, and this collaboration expands our oncology leadership into the growing targeted therapies of PARP and MEK inhibitors. We look forward to working with AstraZeneca to create greater value for patients and shareholders than if both companies worked independently.'
Financial considerations
Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialisation costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from Lynparza and selumetinib Product Sales generated through monotherapies or combination therapies will be shared equally.
Merck will fund all development and commercialisation costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialisation costs of Imfinzi in combination with Lynparza or selumetinib.
AstraZeneca will continue to manufacture Lynparza and selumetinib.
As part of the agreement, Merck will pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options and up to $6.15 billion contingent upon successful achievement of future regulatory and sales milestones. Under the terms of the agreement, AstraZeneca anticipates approximately $1 billion to be recorded under Externalisation Revenue in 2017.
AstraZeneca will book all Product Sales of Lynparza and selumetinib; gross profits due to Merck under the collaboration will be recorded under Cost of Sales. The initial, regulatory and commercial milestone payments will be recorded under Externalisation Revenue. The transaction does not impact AstraZeneca's 2017 financial guidance. AstraZeneca continues to anticipate that the sum of Externalisation Revenue and Other Operating Income in FY 2017 will be ahead of that in FY 2016.
The collaboration agreement was completed upon signing on 26 July 2017.
For the purposes of the UK Listing Authority's Listing Rule LR 10.4.1 R (Notification of class 2 transactions), the book value of gross assets subject to the license and collaboration is approximately $242 million. In view of the development and early growth phase of the medicines, a pre-tax loss of $231 million was attributable to Lynparza and selumetinib in aggregate in the year to 31 December 2016.
NOTES TO EDITORS
About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DDR pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines that target DDR mechanisms in cancer cells. Lynparza is currently approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive, relapsed BRCA-mutated (germline and/or somatic), high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in response (complete or partial) to platinum-based chemotherapy. It is also approved in the US as a monotherapy for patients with deleterious, or suspected deleterious, germline BRCA-mutated (as detected by a US FDA test) advanced ovarian cancer, who have been treated with three or more lines of chemotherapy.
The Company recently presented positive results for Lynparza from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival for patients treated with Lynparza tablets (300mg twice daily), compared to treatment with physician's choice of a standard of care chemotherapy. OlympiAD, a randomised, open label, multi-centre Phase III trial assessing the efficacy and safety of Lynparza in patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious, was the first positive Phase III trial to evaluate the efficacy and safety of PARP inhibitor beyond ovarian cancer. Lynparza is currently being investigated in another separate non-metastatic breast cancer Phase III trial called OLYMPIA. This trial is still open and recruiting patients internationally.
Lynparza generated Product Sales in 2016 of $218 million.
About selumetinib
Selumetinib, licensed by AstraZeneca from Array BioPharma Inc. in 2003, inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumour from growing. Selumetinib is in Phase III development for differentiated thyroid cancer, for which it was granted Orphan Drug Designation by the FDA in May 2016.
Selumetinib is also being tested in a separate Phase II trial in patients with paediatric neurofibromatosis type-1, and in a Phase I trial with patients suffering from advanced solid tumours.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca's five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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BRISTOL-MYERS SHARES SLUMP AFTER FAILED ASTRAZENECA DRUG TRIAL
RTRS
07/27/2017 6:43 PM
(Adds company and analyst comments, updates share price)
By Deena Beasley
July 27 (Reuters) - Bristol-Myers Squibb Co BMY.N shares fell 4 percent on Thursday as investors bet that a failed cancer-drug trial at AstraZeneca Plc AZN.L would have negative implications for Bristol-Myers' similar immunotherapy treatment regimen.
AstraZeneca's Mystic study, released Thursday, looked at a combination of immune system-boosting drugs to treat non-small cell lung cancer (NSCLC). The trial found it was no more effective than chemotherapy in improving the amount of time patients lived without their disease getting worse. (Full Story)
Bristol-Myers is studying a similar combination of its two top drugs in the same therapy class, Opdivo and Yervoy. Its shares were down 4 percent at $53.71 in midday trading.
So far, Merck & Co Inc's MRK.N Keytruda is the only immunotherapy that has been approved as an initial treatment for NSCLC, the most common form of the disease.
Merck shares were up 4 percent on Thursday.
Asked about the implications of AstraZeneca's results during a conference call with analysts and investors, Bristol-Myers Chief Executive Officer Giovanni Caforio said: "It is difficult to speculate on a comparison."
He said the trials involved different drugs, dosing schedules, enrollment sizes and other factors.
Caforio said Bristol-Myers expects to see some results of its trial in the first quarter of 2018, noting an "opportunity for interim results in overall survival by the end of this year."
Also on Thursday, Bristol-Myers reported second-quarter results that largely met analyst expectations.
Sales of Opdivo surged 42 percent from a year earlier to $1.2 billion, while sales of Yervoy rose 34 percent to $322 million. Analysts, on average, expected Opdivo sales of $1.1 billion and Yervoy sales of $307 million, according to Thomson Reuters I/B/E/S.
"The Mystic results increase uncertainty about Bristol's immuno-oncology franchise, particularly Opdivo plus Yervoy in the important first-line NSCLC market, and therefore, in our view, lower the probability of Bristol being acquired as some on (Wall Street) expect," BMO Capital Markets analyst Alex Arfaei said in a research note.
Quarterly sales of blood thinner Eliquis, another important Bristol-Myers drug, jumped 51 percent from a year earlier.
Excluding items, Bristol-Myers earned 74 cents a share, matching the average analyst estimate. Revenue for the quarter rose 6 percent to $5.1 billion.
The company raised the lower end of its forecast range for 2017 adjusted earnings to $2.90 from $2.85 a share, and left the top end unchanged at $3.
Net income for the quarter fell 21 percent to $916 million, while research and development costs rose 31 percent to $1.66 billion.
(Reporting by Deena Beasley in Los Angeles; Additional reporting by Caroline Humer; Editing by Jeffrey Benkoe and Bernadette Baum)
((deena.beasley@thomsonreuters.com; 213 955 6746; Reuters Messaging: deena.beasley.thomsonreuters.com@reuters.net))
Keywords: BRISTOLMYERS RESULTS/ (UPDATE 3)
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BRIEF-ROCHE SAYS REAL DEMAND, NOT STOCKING, DRIVES OCREVUS SALES
RTRS
07/27/2017 2:30 PM
July 27 (Reuters) - Roche Holding AG ROG.S
Roche ceo says no doubt perjeta will be a substantial growth driver
Roche drugs head says astrazeneca lung cancer study failure doesn't change roche's plans
Roche drugs head says sees no risk to regulatory approvals from aphinity study
Roche drugs head says ocrevus sales reflect demand, not major stocking
Roche ceo says bullish about cancer immunotherapy, want to play leading role
Source text for Eikon: [ID:]
Further company coverage: ROG.S
(Reporting By Michael Shields)
((Michael.Shields@thomsonreuters.com;))
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ASTRAZENECA REPORTS INITIAL RESULTS FROM THE ONGOING MYSTIC TRIAL IN STAGE IV LUNG CANCER
CIS
07/27/2017 8:12 AM
AstraZeneca
Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy
The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combination
AstraZeneca and MedImmune, its global biologics research and development arm, today announced progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC).
The combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving PFS compared to SoC in patients whose tumours express PD-L1 on 25% or more of their cancer cells (as determined by the VENTANA PD-L1 (SP263) assay).
As a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over SoC in this disease setting.
The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi monotherapy and OS for the Imfinzi plus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “While the results from the MYSTIC trial for progression free survival in first-line Stage IV non-small cell lung cancer compared with standard of care are disappointing, the trial was designed to assess overall survival and we look forward to evaluating the remaining primary endpoints of overall survival for both mono- and combination therapy.”
AstraZeneca recently received accelerated approval from the US FDA for Imfinzi in previously-treated patients with locally advanced or metastatic urothelial carcinoma (mUC).
About MYSTIC
The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC. Lung cancer is an unapproved use of Imfinzi.
The trial is being conducted in 167 centres across 17 countries, including the US, Canada, Europe, parts of Asia including Japan, Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia. Primary endpoints include PFS and OS.
About Imfinzi
Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.
Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in immuno-oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in mUC and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in mUC, NSCLC, SCLC and HNSCC and in Phase I/II trials in hepatocellular carcinoma (HCC) and haematological malignancies.
About Tremelimumab
Tremelimumab is an investigational human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being investigated in an extensive clinical trial programme in combination with Imfinzi, in NSCLC, mUC, HNSCC, HCC and blood cancers.
About AstraZeneca in NSCLC
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of NSCLC across all stages of disease and lines of therapy. We aim to address unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and ongoing FLAURA and ADAURA trials. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with NSCLC without a known genetic mutation. Our portfolio includes Imfinzi (durvalumab), an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with tremelimumab, an anti-CTLA-4 (MYSTIC, NEPTUNE and POSEIDON trials).
About AstraZeneca’s approach to Immuno-Oncology
Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.
We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PDL1) monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit http://www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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ASTRAZENECA AND MERCK ESTABLISH STRATEGIC ONCOLOGY COLLABORATION
CIS
07/27/2017 8:08 AM
AstraZeneca
Collaboration aims to maximise the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumour types
AstraZeneca and Merck will independently develop and commercialise Lynparza and potential medicine selumetinib in combinations with companies’ respective PD-L1/PD-1 immuno-oncology medicines Imfinzi and Keytruda
Collaboration will significantly expand the potential of Lynparza, the world’s first and leading PARP inhibitor, as a backbone of combination treatments for multiple cancer types; agreement also includes AstraZeneca’s selumetinib, a MEK inhibitor
The companies will share development and marketing costs equally, as well as gross profits from Lynparza and selumetinib
AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
Lynparza’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumour types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients.
The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi (durvalumab) and Keytruda (pembrolizumab).
The companies will also jointly develop and commercialise AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer.
Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Our strategic collaboration builds on scientific evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumours. By bringing together the expertise of two leading oncology innovators, we will accelerate Lynparza’s potential to become the preferred backbone of many immuno-oncology combination therapies as the world’s first and leading PARP inhibitor. This is a truly exciting step and we are pleased to work with Merck, a company that shares our passion for science to deliver new medicines for cancer patients.”
Kenneth C. Frazier, Chief Executive Officer of Merck, said: “This global collaboration between AstraZeneca and Merck, two oncology leaders, will increase the possibilities for patients to have more treatment options for more cancers. Merck continues to build its leadership in immuno-oncology with Keytruda as foundational in monotherapy and combination therapy, and this collaboration expands our oncology leadership into the growing targeted therapies of PARP and MEK inhibitors. We look forward to working with AstraZeneca to create greater value for patients and shareholders than if both companies worked independently.”
Financial considerations
Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialisation costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from Lynparza and selumetinib Product Sales generated through monotherapies or combination therapies will be shared equally.
Merck will fund all development and commercialisation costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialisation costs of Imfinzi in combination with Lynparza or selumetinib.
AstraZeneca will continue to manufacture Lynparza and selumetinib.
As part of the agreement, Merck will pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options and up to $6.15 billion contingent upon successful achievement of future regulatory and sales milestones. Under the terms of the agreement, AstraZeneca anticipates approximately $1 billion to be recorded under Externalisation Revenue in 2017.
AstraZeneca will book all Product Sales of Lynparza and selumetinib; gross profits due to Merck under the collaboration will be recorded under Cost of Sales. The initial, regulatory and commercial milestone payments will be recorded under Externalisation Revenue. The transaction does not impact AstraZeneca’s 2017 financial guidance. AstraZeneca continues to anticipate that the sum of Externalisation Revenue and Other Operating Income in FY 2017 will be ahead of that in FY 2016.
The collaboration agreement was completed upon signing on 26 July 2017.
For the purposes of the UK Listing Authority’s Listing Rule LR 10.4.1 R (Notification of class 2 transactions), the book value of gross assets subject to the license and collaboration is approximately $242 million. In view of the development and early growth phase of the medicines, a pre-tax loss of $231 million was attributable to Lynparza and selumetinib in aggregate in the year to 31 December 2016.
About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DDR pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines that target DDR mechanisms in cancer cells. Lynparza is currently approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive, relapsed BRCA-mutated (germline and/or somatic), high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in response (complete or partial) to platinum-based chemotherapy. It is also approved in the US as a monotherapy for patients with deleterious, or suspected deleterious, germline BRCA-mutated (as detected by a US FDA test) advanced ovarian cancer, who have been treated with three or more lines of chemotherapy.
The Company recently presented positive results for Lynparza from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival for patients treated with Lynparza tablets (300mg twice daily), compared to treatment with physician’s choice of a standard of care chemotherapy. OlympiAD, a randomised, open label, multi-centre Phase III trial assessing the efficacy and safety of Lynparza in patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious, was the first positive Phase III trial to evaluate the efficacy and safety of PARP inhibitor beyond ovarian cancer. Lynparza is currently being investigated in another separate non-metastatic breast cancer Phase III trial called OLYMPIA. This trial is still open and recruiting patients internationally.
Lynparza generated Product Sales in 2016 of $218 million.
About selumetinib
Selumetinib, licensed by AstraZeneca from Array BioPharma Inc. in 2003, inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumour from growing. Selumetinib is in Phase III development for differentiated thyroid cancer, for which it was granted Orphan Drug Designation by the FDA in May 2016.
Selumetinib is also being tested in a separate Phase II trial in patients with paediatric neurofibromatosis type-1, and in a Phase I trial with patients suffering from advanced solid tumours.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit http://www.astrazeneca.com and follow us on Twitter @AstraZeneca.
Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Rob Skelding UK/Global +44 203 749 5821
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Matt Kent UK/Global +44 203 749 5906
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
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Has something to do with milk. A few months ago I posted a paper from Universität Graz. It was something with milk and phosphatidylerine too.
Different Potential of Extracellular Vesicles to Support Thrombin Generation: Contributions of Phosphatidylserine, Tissue Factor, and Cellular Origin
http://www.nature.com/articles/s41598-017-03262-2
Hi Wernaaa,
have you talked with Ronin?
And if so - what was their response?
Thanks
Good Morning!
PEREGRINE PHARMACEUTICALS INC FILES -- 8-K
EDG
25/07/2017 11:00 PM
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20170725:EDG_0001683168-17-001855
Item 8.01 Other Events.
On July 24, 2017, Peregrine Pharmaceuticals, Inc. (the "Company") received a letter from the Nasdaq Office of General Counsel notifying the Company that it has regained compliance with the $1.00 minimum closing bid price requirement set forth in the NASDAQ Listing Rule 5550(a)(2), and is in compliance with other applicable requirements for listing on The Nasdaq Stock Market. Accordingly, the NASDAQ has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market and considers the matter closed.
nEOLbkLVRF
© Thomson Reuters 2017. All rights reserved.
Has nothing to do with PPHM
HIV FIGHT ADVANCES WITH NEW DRUG COCKTAILS, FRESH VACCINE HOPES
RTRS
24/07/2017 10:00 AM
Competing new drug combinations from Gilead and GSK
Long-acting injections, implants a growing focus
Prime-boost HIV vaccine to enter large clinical trial
By Ben Hirschler
LONDON, July 24 (Reuters) - Three decades after approval of the first-ever AIDS treatment, HIV medicine is seeing a new wave of innovation with scientists reporting positive data on Monday for improved drug cocktails and a novel experimental vaccine.
Adding to optimism is the success of antiretrovirals in preventing infection - an approach known as pre-exposure prophylaxis (PrEP) - as well as growing hopes for an eventual 'functional' cure that may keep the virus at bay without drugs.
Researchers believe such advances are necessary to stay ahead of a virus that can all too often develop resistance to medicines, despite the use since 1996 of three- or four-drug combinations that mean HIV/AIDS is no longer a death sentence.
'New products are needed. The Achilles heel for us is drug resistance because the virus is incredibly quick to mutate,' Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Centre in South Africa, said.
Bekker is also president of the International AIDS Society, which organised the conference in Paris where the latest clinical results were presented.
The race for better and more convenient medicines has made HIV a rich battleground for drug companies such as Gilead Sciences GILD.O and GlaxoSmithKline GSK.L, which generate billions of dollars from modern therapies.
Both companies garnered fresh ammunition to boost their products in Paris.
New clinical data confirmed Gilead's new drug bictegravir, given with older antiretrovirals, was as good as GSK's established dolutegravir and had a similar side effect profile. Gilead filed the new cocktail for regulatory approval in June.
Both bictegravir and dolutegravir are so-called integrase inhibitors, a type of medicine that has proved extremely effective at blocking HIV.
GSK, meanwhile, unveiled results of a 96-week study with a long-acting two-drug injection given every four or eight weeks using another integrase inhibitor, cabotegravir, that showed it worked as well - and perhaps better - than standard daily pills.
For GSK, two-drug cocktails represent the future of HIV treatment, especially for the growing number of older patients who are more vulnerable to side effects from taking multiple medicines.
It hopes to win approval for its first dual therapy - a tablet containing dolutegravir - later this year.
GSK's long-acting injection is further off but it offers an option for people who don't want daily pills, which some experts think might be 10 to 20 percent of the market. GSK also faces a rival in Merck & Co MRK.N, which is working on an even longer-lasting drug that could one day be used as an implant.
David Redfern, chairman of GSK's majority-owned ViiV Healthcare HIV business, believes one thing is clear: competition is set to intensify.
'The battle will play through from next year, but we feel in a strong position to defend the franchise that we have built up,' he told Reuters.
Gilead's clinical research head Andrew Cheng said the rival combinations were very comparable and there would now be a shift in treatment to the newer, more effective therapies.
VACCINE NEEDED
Ultimately, many experts believe a vaccine will be needed to shut down the threat from HIV, although decades of efforts to develop one have so far ended in disappointment.
Scientists are not giving up, however, and a new approach pioneered by Johnson & Johnson JNJ.N, working with U.S. government experts and others, is set to enter large Phase IIb trials later this year.
The decision to push ahead with a so-called prime-boost vaccine in a trial involving thousands of patients in Africa comes after promising data presented in Paris on Monday, showing the two-component shot generated a good immune response.
It also follows another large-scale trial already underway in Africa, which uses a modified version of a vaccine that showed a modest 31 percent reduction in infections in Thailand in 2009.
In both cases, researchers are looking for reductions in infection rates of at least 50 percent, and hopefully more.
With 36.7 million people around the world infected with HIV and more than half of them getting treatment that is expected to last for life, J&J Chief Scientific Officer Paul Stoffels sees parallel advances in drugs and vaccines as essential.
'We should not claim victory yet in HIV,' he said. 'The people who are infected today will need therapy for the next 30 to 50 years, so the science of treatment has to evolve - and the science of prevention has to evolve as well to stop the pool of patients growing.'
(Reporting by Ben Hirschler. Editing by Jane Merriman) ((ben.hirschler@thomsonreuters.com; +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))
Keywords: HEALTH AIDS/PHARMACEUTICALS (EMBARGOED, PIX)
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© Thomson Reuters 2017. All rights reserved.
Viral infection: When two become one
Published online 24 July 2017
...receptors induces the redistribution of phosphatidylserine to the host cell surface... ...gp120 induced the redistribution of phosphatidylserine from the inner leaflet of... ...anoctamin 6-mediated externalization of phosphatidylserine. In agreement with this,... ...exogenous phosphatidylserine...Ashley York
Nature Reviews Microbiology
http://www.nature.com/nrmicro/journal/vaop/ncurrent/full/nrmicro.2017.85.html?WT.feed_name=subjects_infectious-diseases&foxtrotcallback=true
Both I can't speak!
Liposome-based immunotherapy, therapeutic effect on MS
Fri Jul 14, 2017 1:26 am
Liposome-based immunotherapy against autoimmune diseases: therapeutic effect on multiple sclerosis.
Nanomedicine (Lond). 2017 Jun;12(11):1231-1242.
AIM: Based on the ability of apoptosis to induce immunological tolerance, liposomes were generated mimicking apoptotic cells, and they arrest autoimmunity in Type 1 diabetes. Our aim was to validate the immunotherapy in other autoimmune disease: multiple sclerosis.
MATERIALS & METHODS: Phosphatidylserine-rich liposomes were loaded with disease-specific autoantigen. Therapeutic capability of liposomes was assessed in vitro and in vivo.
RESULTS: Liposomes induced a tolerogenic phenotype in dendritic cells, and arrested autoimmunity, thus decreasing the incidence, delaying the onset and reducing the severity of experimental disease, correlating with an increase in a probably regulatory CD25+ FoxP3- CD4+ T-cell subset.
CONCLUSION: This is the first work that confirms phosphatidylserine-liposomes as a powerful tool to arrest multiple sclerosis, demonstrating its relevance for clinical application.
http://www.thisisms.com/forum/natural-approach-f27/topic29234.html
Phosphatidylserine externalization, “necroptotic bodies” release, and phagocytosis during necroptosis
http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2002711
Fusion Stage of HIV-1 Entry Depends on Virus-Induced Cell Surface Exposure of Phosphatidylserine
12 July 2017
Highlights
•HIV-cell binding triggers phosphatidylserine (PS) exposure at the cell surface•PS exposure depends on gp120-coreceptor interactions, Ca2+ signaling, and TMEM16F•Suppression of PS exposure inhibits Env restructuring, viral fusion, and infection•PS signaling, a hallmark of activation, facilitates HIV entry
http://www.cell.com/cell-host-microbe/fulltext/S1931-3128(17)30252-4?_returnURL=http%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1931312817302524%3Fshowall%3Dtrue
Stimulatory role of exosomes in the context of therapeutic anti-cancer vaccines