Life long Maverick: Seen it ALLl in 40 yrs of PROF. exposure as invest analyst/port mgr on the FRONT lines vs iHub Msg Bds.
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NWBO is “in the catbird’s seat “ although it’s priced for death by the marketplace
Thanks PGSD for your super sleuthing re Dec 11th Boston NWBO CTO Dr. Marnix Bosch presenting
Quote:
"Outlining the key aspects of the DCVax technology that contribute to the positive clinical results"
THIS IS YET ANOTHER ADDITION to the
UPCOMING MOTHER of ALL TSUNAMIs in SOLID Tumors:
The STARS have been ALIGNING for the unveiling of Top Line Data on Ph3 DCVAX L BEFORE mid Dec 2019!
June 2019 ASCO with the eye witness identification of MRK's EVP Roger Perlmutter shaking hands with CEO Linda Powers by our oncologist iHub brethren:
AlphaPuppy! and Photonic5! along with prompting by Erik007 that began late August 2019:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151055015
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151005183
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151004805
The Sept 4, 2019 hiring from Merck of Dr. Duffy:
https://nwbio.com/nw-bio-expands-senior-management-team-with-dr-kevin-duffy-as-vice-president-medical-affairs-external-collaborations/
So the work in process jigsaw puzzle for evolving NWBO calendar CURRENTLY looks like this:
Oct 25 8:30 PST AM: UCLA's Dr. Linda Liau the Private Investigator for DCVAX L to present in Salt Lake City's Huntsman Cancer Center:
https://healthcare.utah.edu/huntsmancancerinstitute/events/2019/brain-tumor.php
SNO : FOUR DAYS 11/21/24 in Phoenix, AZ BIG EVENT (likely 2nd largest oncologists confab after May/June ASCO)
https://www.eventscribe.com/2019/sno/agenda.asp?pfp=FullSchedule
Lots of drop down menu's revealing most ALL of UCLA's Dr. Linda Liau's staff/associates: Dr.:Robert M. Prins & Dr. Timothy F. Cloughesy ETC ; John Hopkins Dr. Michael Lim (worked on DCVAX L).and Dr.Michael Lim is the Director of the Brain Cancer Immunology Laboratory at Johns Hopkins. See post: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148242117
There are some slots left at SNO where NWBO can FILL? Would NOT rule it out YET!
Dec 6th UCLA's Dr. Linda Liau at Miami's 3rd Annual Brian Symposium :
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151619108
http://MiamiBrainSymposium.BaptistHealth.net
Dec 11th NWBO's Chief Technical Officer Dr. Marnix Bosch:
This Glioblastoma Drug Development Summit Conference in Boston encompasses a who's who's
in GBM:
Prominent peers of Dr. Linda Liau on the East Coast: Boston's Dr. Patrick Wen:
https://www.dana-farber.org/find-a-doctor/patrick-y-wen
A Randomized Double-Blind Placebo-Controlled Phase 2 Trial Of Dendritic Cell Vaccine ICT-107 In Newly Diagnosed Patients With Glioblastoma https://clincancerres.aacrjournals.org/content/early/2019/07/18/1078-0432.CCR-19-0261
Dr. Reardon was the Private Investigator on Celldex rGBM FAILED cancer vaccine rindopepimut: https://www.ascopost.com/issues/july-10-2016/expert-point-of-view-david-reardon-md/
https://glioblastoma-drugdevelopment.com/about/agenda/day-two/
==============================================================
maverick_1 Monday, 10/21/19 04:39:57 PM
Re: pgsd post# 248401
Post # of 248499
NWBO is “in the catbird’s seat “ although it’s priced for death by the marketplace
Thanks PGSD for your super sleuthing re Dec 11th Boston NWBO CTO Dr. Marnix Bosch presenting
Quote:
"Outlining the key aspects of the DCVax technology that contribute to the positive clinical results"
THIS IS YET ANOTHER ADDITION to the
UPCOMING MOTHER of ALL TSUNAMIs in SOLID Tumors:
The STARS have been ALIGNING for the unveiling of Top Line Data on Ph3 DCVAX L BEFORE mid Dec 2019!
June 2019 ASCO with the eye witness identification of MRK's EVP Roger Perlmutter shaking hands with CEO Linda Powers by our oncologist iHub brethren:
AlphaPuppy! and Photonic5! along with prompting by Erik007 that began late August 2019:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151055015
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151005183
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151004805
The Sept 4, 2019 hiring from Merck of Dr. Duffy:
https://nwbio.com/nw-bio-expands-senior-management-team-with-dr-kevin-duffy-as-vice-president-medical-affairs-external-collaborations/
So the work in process jigsaw puzzle for evolving NWBO calendar CURRENTLY looks like this:
Oct 25 8:30 PST AM: UCLA's Dr. Linda Liau the Private Investigator for DCVAX L to present in Salt Lake City's Huntsman Cancer Center:
https://healthcare.utah.edu/huntsmancancerinstitute/events/2019/brain-tumor.php
SNO : FOUR DAYS 11/21/24 in Phoenix, AZ BIG EVENT (likely 2nd largest oncologists confab after May/June ASCO)
https://www.eventscribe.com/2019/sno/agenda.asp?pfp=FullSchedule
Lots of drop down menu's revealing most ALL of UCLA's Dr. Linda Liau's staff/associates: Dr.:Robert M. Prins & Dr. Timothy F. Cloughesy ETC ; John Hopkins Dr. Michael Lim (worked on DCVAX L).and Dr.Michael Lim is the Director of the Brain Cancer Immunology Laboratory at Johns Hopkins. See post: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148242117
There are some slots left at SNO where NWBO can FILL? Would NOT rule it out YET!
Dec 6th UCLA's Dr. Linda Liau at Miami's 3rd Annual Brian Symposium :
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151619108
http://MiamiBrainSymposium.BaptistHealth.net
Dec 11th NWBO's Chief Technical Officer Dr. Marnix Bosch:
This Glioblastoma Drug Development Summit Conference in Boston encompasses a who's who's
in GBM:
Prominent peers of Dr. Linda Liau on the East Coast: Boston's Dr. Patrick Wen:
https://www.dana-farber.org/find-a-doctor/patrick-y-wen
A Randomized Double-Blind Placebo-Controlled Phase 2 Trial Of Dendritic Cell Vaccine ICT-107 In Newly Diagnosed Patients With Glioblastoma https://clincancerres.aacrjournals.org/content/early/2019/07/18/1078-0432.CCR-19-0261
Dr. Reardon was the Private Investigator on Celldex rGBM FAILED cancer vaccine rindopepimut: https://www.ascopost.com/issues/july-10-2016/expert-point-of-view-david-reardon-md/
https://glioblastoma-drugdevelopment.com/about/agenda/day-two/
==============================================================
Re Yet ANOTHER reason for NO Bristol Myers interest in NWBO:
CELG sold to BMY! 2023 Ph3 GBM Results 700+ patients
https://clinicaltrials.gov/ct2/show/NCT03345095
======+=================================
AS FOR: Neil Woodford re FORBES:
803 views|Oct 20, 2019,9:24 am
The Fall Of Neil Woodford Will See New Fund Management Rules
Stephen PopeContributor
Markets
I focus on developments on economic and market aspects within Europe.
[+]
There is a saying that suggests when a rider falls from a horse, the first thing that they should do is climb back on. Neil Woodford, a well-known investment manager and active equestrian, may find that the horse that was his career has bolted and may prove hard to recapture, let alone remount.
Woodford Investment Management is closing its doors as Woodford was dismissed from its flagship fund. This has left many pensioners and small investors staring at significant losses with little idea of how they can recoup the lost funds.
The effect has created a large circle of ripples as the entire fund management industry is going to come under the scrutiny of regulators and politicians.
One can understand why the spotlight will be intense as Woodford, who at one time was the custodian of £30 billion ($38.1 billion) of assets under management was considered an industry superstar.
That might sound rather glib. So, let me put it some context. An investment of £10,000 ($12,700) in 1988 when Woodford began at Invesco Perpetual would have grown to almost £250,000 when he left in 2013. So high had his reputation risen that when he established his own firm, Woodford Equity Income Fund (WEIF), in 2014, he raised £1.7 billion ($2.16 billion) in a fortnight. One year later he was described by the BBC as “the man who can’t stop making money.”
Regulators will be concerned as thousands of individuals put large sums of money into his care. Indeed, for many, Woodford was their one and only fund. It therefore follows that they could have lost a significant proportion of their pension fund.
The recent timeline shows that in 2015 Woodford launched Woodford Patient Capital Trust (WPCT) to invest in early-stage U.K. firms. The WPCT fund attracted £800 million ($1.02 billion) when it floated in April 2015, proving to be the ever-biggest fundraising for an investment trust in the U.K.
WEIF performed extremely well, booking a gain of 20% in its first year and the assets rose to an incredible £6.7 billion ($8.5 billion) by the end of July.
In 2017 Woodford’s fortunes began to decline as a change in WPCT’s remit to allowed it to invest in more unlisted companies, as well as more firms outside the U.K. This was followed by a poor run of performance by several key investments leading the asset manager, Jupiter to withdraw £300 million ($381 million).
Over 2018 and 2019 WEIF almost broke its limits of holding only 10% of its assets in unquoted assets and, with further declines in asset value, the pace of investors pulling money accelerated to a such a rate that Woodford was unable to sell assets fast enough to keep up with withdrawal demand.
The administrator “gated” the fund in June in an attempt to prevent savers from withdrawing any further funds. Despite the inability of investors to withdraw money, Woodford continued to collect £65,000 a day in management fees leading to a significant increase in public and political criticism.
Investors in WEIF have lost 37% of their savings since 2016. They have been given an ominous warning by the administrators to expect further declines as the fund, which has sacked Woodford is wound up.
The investment behaviour which was overlooked when the funds were rising has drawn criticism as the returns moved into the red. The same is the case over the fact that since 2015 Woodford has collected £63 million ($80 million) in income payments.
Be in no doubt, this is a serious development as funds rarely get completely suspended unless a serious case of fraud has been uncovered. To echo the importance of this development Bank of England governor Mark Carney said the shuttering of Woodford’s funds highlighted the structural problem of open-ended investment funds, which offer the investors the right to take their money out whenever they like.
There will be a long and detailed enquiry that will delve into the operational process of charges and transparency of stock holdings. There will almost certainly be new regulations that will obligate fund managers to reveal the proportion of money held in illiquid assets.
On reflection, it would seem Woodford was too quick to accept so much inward investment and certainly placed too big a bet on illiquid assets. He ignored the critical test of liquidity—is there a realistic bid price when one needs it?
Get the best of Forbes to your inbox with the latest insights from experts across the globe.
Follow me on Twitter. Check out my website.
Stephen Pope
===================================================
Said this over 5 yrs ago and EVEN MORE APPLICABLE:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=104907802
================================================
Why I recommended to both Larry Smith and Flipper ALL to NO AVAIL over 5 yrs ago The Baker Bros versus FLAMEOUT Neil Woodford:
https://www.bloomberg.com/news/articles/2019-10-21/baker-brothers-biotech-bet-makes-730-million-in-overnight-bump
=====================================================
MUCH WORST than Neil Woodford is $30+ Bln with this other U.K. $Mgr: that I saw yesterday
========================================
https://www.cnn.com/2019/10/21/investing/china-wealth-americans/index.html
.=====================•==========================
Responses: Sniper Attacks on INCONSEQUENTIALS underscore your OWN INSECURITIES!
STARS are NOW TOTALLY ALIGNED for IMHO Top Line Data BEFORE Dec 6th Third Annual Miami Brain Symposium,post below:
I agreed with todays tweetS by Carlo Rago
as well as with todays posts by Skitahoe
that also dovetails with these previous posts of mine below:
No further elaboration needed.
Dr. Linda Liau,chair of neurosurgery at the David Geffen School of Medicine at UCLA, has been appointed chair of the American Board of Neurological Surgery.She is the first woman to lead the organization in its 80-year history.
UCLA Newsroom
FACULTY BULLETIN BOARD
UCLA doctor leads American Board of Neurological Surgery
Dr. Linda Liau
American Board of Neurological Surgery
Dr. Linda Liau
Elaine Schmidt | October 11, 2019
Dr. Linda Liau, chair of neurosurgery at the David Geffen School of Medicine at UCLA, has been appointed chair of the American Board of Neurological Surgery. She is the first woman to lead the organization in its 80-year history.
In her role, Liau chairs the board’s executive committee and presides over all meetings of the directors and board of directors. Her tenure will end on May 31, 2020.
The American Board of Neurological Surgery is responsible for certifying prospective practitioners of brain and spinal surgery in the United States. Board certification is a rigorous process that identifies physicians who merit the distinction of being called specialists. Since it was founded in 1940, the ABNS has certified 7,465 neurological surgeons in the United States.
Media Contact
Elaine Schmidt
UCLA
310-267-8323
eschmidt@mednet.ucla.edu
INTERESTING to SEE LOADS of FLIP FLOPS todayre Neil Woodford!!
How anyone expected otherwise which was apparent to me since 2015:
Why I SOLD: NWBO lost it’s former captive long term financier and HAD to deal with TOXIC financing and extreme dilution:
NONE of which Pied Pipers foresaw: Why everyone did not see that BIG CURVE AHEAD along with OTHERS speaks VOLUMES!
The REAL Marketplace speaks louder than the yearS of bucketS of horse dung here.
LOTS of real world competitive developments to usurp whatever AVXL has ongoing.
ie: https://www.genengnews.com/topics/drug-discovery/lilly-making-first-milestone-payment-in-1-9b-collaboration-with-ac-immune/
So why is it that AVXL has NO one collaborating or even licensing it's technology to FUND it's technology versus having to do LPC ATM and/or it's large SHELF registration??
THATS WHY:
9 of last 13 trading days have been DOWN
POOR Technicals :
UNDER BOTH 50 and 200 day moving averages
DECLINING Rel Strength even relative to XBI!
35 vs 44
WIDENING Negative MACD
at low end of Bollinger Bands
ADX PLUS growingly NEGATIVE
Chaiklin Money Flow has NOT been postive since May 2019
Accum/Disribution has been NEGATIVE since mis May 2019
NEARING Death Cross
NEEDED Follow up to BMY removed end of Aug 2019 from M/A or partnership with NWBO is:
Glaxo (GSK) NEW Addiction to NON NWBO altar like future:
Exclusive: GSK’s Hal Barron allies with Rick Klausner’s $600M cell therapy startup, looking to break new ground blitzing solid tumors
LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million Klausner’s raised in the past year to make that vision a reality.“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.” Stan Riddel lNow Barron’s putting GSK’s considerable R&D resources to work on that mission, which involves a tie-up that until now has only been hinted at. The company isn’t saying publicly just how big their check is for an upfront and equity stake in Lyell, which has recruited a team of 150, with plans to bring in another 25 staffers by the end of this year. But nothing about Lyell is small, as Barron will explain in more detail during our one-on-one session at the UK biotech summit in London today.At a time when cancer research, in general, has been booming, and immuno-oncology, in particular, has been the stage of some of the best-funded programs in the industry, Lyell is a standout. Its syndicate of investors includes Bob Nelsen at ARCH, who loves nothing better than marshaling hundreds of millions of dollars with co-investors to create companies that have grand plans in mind. Nick Restifo Klausner’s plan was to create one of the best teams in cancer research, and he says Barron fits perfectly into a group that makes up a virtual who’s who in the field. Klausner’s decades-long work in the field — his lab is credited with discovering the molecular engine behind T cell receptors and CAR signaling — gave him some of the best connections in the industry.The co-founder of the company is Stan Riddell, who left the Fred Hutch at the end of August after decades of work to take the helm on research at Lyell. Nick Restifo, EVP of science, spent 25 years at the NCI, working on T cells and the therapeutic benefit they could bring. Margo Roberts Then there’s Margo Roberts, CSO, who helped lead the charge on Yescarta, the groundbreaking CAR-T from Kite that has emerged as the dominant cell therapy, surpassing Novartis.Crystal Mackall of Stanford and David Baker of the University of Washington are credited as scientific founders, creating a significant part of the IP that Lyell is working with. Crystal MackallIt’s all preclinical, says Klausner, who expects to stay in animals, testing new technologies as they work out the first human studies over the next 2 years. The academic work has involved several technologies aimed at preventing cell exhaustion, relying on genetic manipulation to reenergize cells that flatline in a solid tumor’s microenvironment. In animals — and Klausner is quick to offer the caveat that it’s an imperfect area of cancer research — researchers have been working with a genetic switch to animate exhausted cells. And they’ve been using protein engineering to design cells for specificity and safety. David Baker The company is named after Sir Charles Lyell, the father of geology, who “freed biology to think of accumulation of changes over time,” says Klausner. “You couldn’t have evolution without the gift of time.”For Barron, the tech has a variety of uses for GSK, starting with plans to soup up their development program for GSK3377794, which targets the NY-ESO-1 antigen found on a variety of cancer cells.“I find Hal one of the wisest people I’ve ever sat on a board with,” Klausner says, recalling their years on the Juno board. In looking to transform GSK’s R&D group, which has suffered from years of drift and disarray, Barron specifically wanted to interact with a high energy startup and understood the challenges involved in getting a Big Pharma and an upstart to work together[. Says Klausner: “He understood both sides of that cultural chasm.” And Barron was quick to caution him: “Do not do this deal unless you’re convinced that this relationship will make it more likely that you will succeed.”Building the company so far has meant creating operations in San Francisco as well as Seattle, where Riddell is based. It’s been about a 60/40 split between the two cities, says Klausner. That puts him physically close to Barron’s San Francisco base, which has opened doors to a variety of new alliances in the Bay Area, including their joint genomics lab with Jennifer Doudna and Jonathan Weissman. Barron’s intense interest in genetics as a springboard for drug development also led him to align himself with 23andMe in the tech metropolis where he works, far from GSK’s main research hubs in Stevenage, UK and Philadelphia.Barron has been clear that there are no plans to add a research campus in the Bay Area, but he enjoys allying with the people and companies he’s grown close to over the years at Genentech and then Calico. That geographically expansive approach in adding US collaborations includes the Tesaro buyout, where he plans to break new ground in PARP operating in the big Boston hub. Barron’s selective, but he’s a long way from finished in rebuilding the pipeline, using a mix of deals and acquisitions to change everything from preclinical research through late-stage development.
AUTHOR John Carroll EDITOR & FOUNDER
Thanks to Dr Bala & Sharpie for the Addendum ADDITIONS!
Hopefully ALL of you may in reflection feel what I sense: CEO Linda Powers
IMHO was influential in orchestrating the “whole enchilada as displayed” as either a
Pre or Post drum roll for DCVAX L Top Line Data in laying the FIRST of MANY high profile
Trade Forums with highly respected KEY Opinion Leaders that will canvas ALL!
THE NEW DAWN will be BLINDINGLY BRIGHT!
BTW don’t believe this was posted:
Why some brain tumors respond to immunotherapy
Study could help identify patients with glioblastoma who are most likely to respond to immunotherapy.
COLUMBIA UNIVERSITY IRVING MEDICAL CENTER
NEW YORK, NY (February 15, 2019)-- Columbia researchers have learned why some glioblastomas--the most common type of brain cancer--respond to immunotherapy. The findings could help identify patients who are most likely to benefit from treatment with immunotherapy drugs and lead to the development of more broadly effective treatments.
The study, led by Raul Rabadan, PhD, professor of systems biology and biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons, was published online in the journal Nature Medicine.
Fewer than 1 in 10 patients with glioblastoma¬ respond to immunotherapy, which has shown remarkable success in the last few years in treating a variety of aggressive cancers. But there has been no way to know in advance which glioblastoma patients will respond.
Patients with glioblastoma are typically treated with surgery to remove as much of the tumor as possible, followed by radiation and chemotherapy. Even with aggressive therapy, the prognosis is often grim, with median survival of around 14 months.
Like many other cancers, glioblastomas are able to prevent the immune system from attacking cancer cells. Cancers sometimes put the brakes on the immune system by acting on a protein called PD-1. Immunotherapy drugs called PD-1 inhibitors are designed to release those brakes, unleashing the immune system. Given the success of PD-1 inhibitors in other cancers, doctors were hopeful that the immunotherapy drugs would help patients with glioblastoma.
To understand why only a few of these tumors respond to the immunotherapy drugs, Rabadan's team took a comprehensive look at the tumor microenvironment--which includes the tumor itself and all of the cells that support it--in 66 glioblastoma patients before and after treatment with PD-1 inhibitors (nivolumab or pembrolizumab). (Of these, 17 had a response to the drugs of 6 months or longer.)
Non-responsive tumors had more mutations in a gene called PTEN, which led to higher levels of macrophages--immune cells that usually help the body fight bacteria ands other invaders. But in glioblastoma, the macrophages release a number of growth factors that promote the survival and spread of cancer cells.
Cancer cells in tumors with PTEN mutations were also tightly clustered together, which may prevent immune cells from penetrating the tumor and its microenvironment.
Responsive tumors, on the other hand, had more mutations in a signaling pathway called MAPK, which helps regulate essential cellular functions.
"These mutations occurred before patients were treated with PD-1 inhibitors, so testing for the mutations may offer a reliable way to predict which patients are likely to respond to immunotherapy," says neuro-oncologist Fabio M. Iwamoto, MD, assistant professor of neurology at Columbia University Vagelos College of Physicians and Surgeons and a co-author of the study.
The study also suggests that glioblastoma patients with MAPK mutations may benefit more from immunotherapy if PD-1 inhibitors are combined with MAPK-targeted therapy, though the combination would require clinical testing. MAPK-targeted therapies have been approved for metastatic melanoma and are currently being tested to treat other cancers.
"We're still at the very beginning of understanding cancer immunotherapy, particularly in glioblastoma," says Ramadan. "But our study shows that we may be able to predict which glioblastoma patients might benefit from this therapy. We've also identified new targets for treatment that could improve immunotherapy for all glioblastoma patients."
###
Raul Rabadan, PhD, and Fabio Iwamoto, MD, are also part of the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian/Columbia University Irving Medical Center.
The study is titled, "Immune and genomic correlates of response tobanti-PD-1 immunotherapy in glioblastoma." The other contributors are: Junfei Zhao (CUIMC), Andrew X. Chen (CUIMC), Robyn D. Gartrell (CUIMC), Andrew M. Silverman (CUIMC), Luis Aparicio (CUIMC), Tim Chu (CUIMC), Darius Bordbar (CUIMC), David Shan (CUIMC), Jorge Samanamud (CUIMC), Aayushi Mahajan (CUIMC), Ioan Filip (CUIMC), Rose Orenbuch (CUIMC), Morgan Goetz (University of North Carolina at Chapel Hill, Chapel Hill, NC), Jonathan T. Yamaguchi (Northwestern University Feinberg School of Medicine, Chicago, IL), Michael Cloney (Northwestern), Craig Horbinski (Northwestern), Rimas V. Lukas (Northwestern), Jeffrey Raizer (Northwestern), Ali I Rae (Oregon Health & Sciences University, Portland, OR), Jinzhou Yuan (CUIMC), Peter Canoll (CUIMC), Jeffrey N. Bruce (CUIMC), Yvonne M. Saenger (CUIMC), Peter Sims (CUIMC), Fabio M. Iwamoto (CUIMC), and Adam M. Sonabend (Northwestern).
The study was supported by grants from the National Institutes of Health (R01 CA185486, R01 CA179044, U54 CA193313, U54 209997, and R01 NS103473), National Science Foundation/Stand Up 2 Cancer/V-Foundation Ideas Lab Multidisciplinary Team, Keep Punching Foundation, SPORE for Translational Approaches to Brain Cancer, and the Robert H. Lurie NCI Cancer Center.
The authors declare no financial or other conflicts of interest.
Columbia University Irving Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the Vagelos College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions.
Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.
Media Contact
Lucky Tran
lt2549@cumc.columbia.edu
@ColumbiaMed
http://www.cumc.columbia.edu [/quote]https://cancer.columbia.edu/fabio-m-iwamoto-md
CONSTRAINED : ONE daily post!
Dec 6th MIAMI UCLA's Dr. Linda Liau to PRESENT: Role of Immunotherapy in Gliomas & Panelist
AND
TTFields: The Great Debate
Third Annual Miami Brain Symposium 06 Dec 2019 • Miami, United States Abstract: The Miami Brain Symposium will focus on state-of-the-art approaches in the management of primary and metastatic brain and spine tumors, along with an understanding of current standards of care as well as a look at future directions. For one full day this symposium will engage participants, as the expert faculty navigate through complex cases and novel treatment strategies and lively panel discussions.Contact: Phone: [786-596-2398]; Email: JulieZ@BaptistHealth.netTopics: Neurooncology CME, Neurooncology Conference, Baptist Health CME, Miami Brain SymposiumEvent listing ID: 1261222Related subject(s): Neurology, NeuroradiologyEvent website: http://MiamiBrainSymposium.BaptistHealth.net
Advancing Glioma Management
Moderator: Yazmin Odia, M.D.?
01:05 PM
Chemotherapy for Glioblastoma: The Empire Strikes Back
Fabio M. Iwamoto, M.D.: https://cancer.columbia.edu/fabio-m-iwamoto-md1:30 PM
TTFields: The Great Debate
Pro: Nicholas Avgeropoulos, M.D.
https://www.orlandohealthcancer.com/physician-finder/nicholas-g-avgeropoulos-md?hcmacid=a0bi000000KhlMdAAJ
Orlando Health was one of NVCR's Optune nGBM test locations: https://clinicaltrials.gov/ct2/show/study/NCT00916409?show_locs=Y#locn
Con: Jaishri Blakeley, M.D.
02:15 PM
Jaishri Blakeley, MD
Jaishri Blakeley, MD
Background
Dr. Jaishri Blakeley is a Professor in Neurology, Oncology and Neurosurgery (Neuro-oncology). She is the Director of the Johns Hopkins Comprehensive Neurofibromatosis Center, and Director of the United Counsel of Neurologic Subspecialties (UCNS) Neuro-Oncology Fellowship at Johns Hopkins. She is also a member of the Adult Brain Tumor Consortium and the Department of Defense Neurofibromatosis Clinical Trials Consortium and a member of the Executive Committee of the Neuro-Oncology Section of the American Academy of Neurology and the education committee of the American Society of Clinical Oncology.
Dr. Blakeley’s research expertise is in the development of clinical trials for nervous system tumors and specifically, in early clinical-translational studies of new drugs including tumor pharmacokinetic and pharmacodynamic investigations for rare tumors. She serves as the national chairperson for four multi-center clinical trials. Her research is supported by the National Cancer Institute: Cancer Therapy Evaluation Program, foundation awards such as the Career Development Award from the American Society for Clinical Oncology, the Children’s Tumor Foundation clinical trial award, industry research collaborations and philanthropic collaborations.
Dr. Jaishri Blakeley graduated from Barnard College, Columbia University Magna Cum Laude with a B.A. in Psychology in 1994. She then worked at the University of Texas Southwestern as a research assistant investigating neurophysiology in patients with schizophrenia confirming her commitment to a career in medicine. She subsequently graduated from the Baylor College of Medicine in 2001 with honors and multiple awards including AOA membership. She completed her Neurology training at The Johns Hopkins Hospital in 2005 and her specialty training in Neuro-oncology via a National Cancer Institute T32 training grant at Johns Hopkins in 2007 at which time she was recruited to the faculty of Johns Hopkins University.
In major meta-analysis, omega-3 fish oil supplements linked with lower cardiovasc
4 hours ago
Harvard T.H. Chan School of Public Health
Credit: CC0 Public Domain
People who received omega-3 fish oil supplements in randomized clinical trials had lower risks of heart attack and other cardiovascular disease (CVD) events compared with those who were given placebo, according to a new meta-analysis from Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital. Researchers found an association between daily omega-3 supplementation and reduced risk of most CVD outcomes, including heart attack, death from coronary heart disease, and death from CVD, but did not see benefit for stroke. In addition, higher doses of omega-3 fish oil supplements appeared to provide even greater risk reduction.
The study will be published online September 30, 2019 in the Journal of the American Heart Association.
"This meta-analysis provides the most up-to-date evidence regarding the effects of omega-3 supplementation on risk of multiple CVD outcomes. We found significant protective effects of daily omega-3 supplementation against most CVD outcome risks and the associations appeared to be in a dose-response manner," said first author Yang Hu, a postdoctoral fellow in the Department of Nutrition at Harvard Chan School.
While observational studies have shown an association between fish consumption and lower heart disease risk, results from randomized controlled trials (RCTs) have been inconsistent. Two reviews published last year did not find clear evidence for benefit.
In this new analysis, the researchers did an updated meta-analysis that included three recently completed large-scale trials, which increased the sample size by 64%. The total population analyzed by Hu and colleagues included more than 120,000 adults in 13 randomized trials worldwide. The analysis included the VITAL trial, the largest randomized trial of omega-3s to date.
The findings showed that people who took daily omega-3 fish oil supplements, compared with those who took a placebo, lowered their risk for most CVD outcomes except stroke, including an 8% reduced risk for heart attack and coronary heart disease (CHD) death. The association was particularly evident at higher doses of omega-3 fish oil supplementation. This finding may suggest that marine omega-3 supplementation dosage above the 840 mg/day used in most randomized clinical trials may provide greater reductions in CVD risk. Given that several million people experience these CVD events worldwide each year, even small reductions in risk can translate into hundreds of thousands of heart attacks and CVD deaths avoided, according to the researchers.
"Although public health recommendations should focus on increasing fish consumption, having an overall heart-healthy diet, being physically active, and having other healthy lifestyle practices, this study suggests that omega-3 supplementation may have a role in appropriate patients," said senior author JoAnn Manson, chief of the Division of Preventive Medicine at Brigham and Women's Hospital and professor in the Department of Epidemiology at Harvard Chan School. Manson is also the Director of the large-scale VITAL trial of omega-3s.
More information: Journal of the American Heart Association (2019). DOI: 10.1161/JAHA.119.013543
Journal information: Journal of the American Heart Association
Provided by Harvard T.H. Chan School of Public Health
In major meta-analysis, omega-3 fish oil supplements linked with lower cardiovasc
4 hours ago
Harvard T.H. Chan School of Public Health
Credit: CC0 Public Domain
People who received omega-3 fish oil supplements in randomized clinical trials had lower risks of heart attack and other cardiovascular disease (CVD) events compared with those who were given placebo, according to a new meta-analysis from Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital. Researchers found an association between daily omega-3 supplementation and reduced risk of most CVD outcomes, including heart attack, death from coronary heart disease, and death from CVD, but did not see benefit for stroke. In addition, higher doses of omega-3 fish oil supplements appeared to provide even greater risk reduction.
The study will be published online September 30, 2019 in the Journal of the American Heart Association.
"This meta-analysis provides the most up-to-date evidence regarding the effects of omega-3 supplementation on risk of multiple CVD outcomes. We found significant protective effects of daily omega-3 supplementation against most CVD outcome risks and the associations appeared to be in a dose-response manner," said first author Yang Hu, a postdoctoral fellow in the Department of Nutrition at Harvard Chan School.
While observational studies have shown an association between fish consumption and lower heart disease risk, results from randomized controlled trials (RCTs) have been inconsistent. Two reviews published last year did not find clear evidence for benefit.
In this new analysis, the researchers did an updated meta-analysis that included three recently completed large-scale trials, which increased the sample size by 64%. The total population analyzed by Hu and colleagues included more than 120,000 adults in 13 randomized trials worldwide. The analysis included the VITAL trial, the largest randomized trial of omega-3s to date.
The findings showed that people who took daily omega-3 fish oil supplements, compared with those who took a placebo, lowered their risk for most CVD outcomes except stroke, including an 8% reduced risk for heart attack and coronary heart disease (CHD) death. The association was particularly evident at higher doses of omega-3 fish oil supplementation. This finding may suggest that marine omega-3 supplementation dosage above the 840 mg/day used in most randomized clinical trials may provide greater reductions in CVD risk. Given that several million people experience these CVD events worldwide each year, even small reductions in risk can translate into hundreds of thousands of heart attacks and CVD deaths avoided, according to the researchers.
"Although public health recommendations should focus on increasing fish consumption, having an overall heart-healthy diet, being physically active, and having other healthy lifestyle practices, this study suggests that omega-3 supplementation may have a role in appropriate patients," said senior author JoAnn Manson, chief of the Division of Preventive Medicine at Brigham and Women's Hospital and professor in the Department of Epidemiology at Harvard Chan School. Manson is also the Director of the large-scale VITAL trial of omega-3s.
More information: Journal of the American Heart Association (2019). DOI: 10.1161/JAHA.119.013543
Journal information: Journal of the American Heart Association
Provided by Harvard T.H. Chan School of Public Health
Underscoring Cognate BioSciences HURDLING previous difficulties of mfg transitions to Sawston, UK/ Fraunhofer Institute for Cell Therapy and Immunology, Germany/Cognate BioSciences Memphis, TN USA in the below Sept 24, 2019 article:
RE: https://www.izi.fraunhofer.de/en/press/press-releases/manufacturing-immunotherapeutics-for-the-treatment-of-brain-tumors.html DATED Aug 2018
RE:https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Press/2018/20180608_Press%20release_Manufacturing%20immunotherapeutics%20for%20the%20treatment%20of%20brain%20tumors%20%E2%80%93%20preliminary%20study.pdf DATED June 2018
Controlling Product Quality is the Name of the Game for Continuous Bioprocessing published Sept 24,2019
What are some challenges in continuous processing, particularly protein glycosylation and scaleup, and in technology transfer from one site to another? Those were the issues discussed by Rustin Shenkman, PhD, associate director, biologics process development at Shire, now part of Takeda, during his presentation at the recent Bioprocess International Conference in Boston which was titled, “Control of Protein Glycosylation in a Continuous Bioreactor Process.”
Maintaining product quality is a risk for any process scaleup or site transfer. All the more so for a highly glycosylated protein whose mode of action or patient safety depends on those post-translational modifications. For instance, a new bioreactor design or even a scaleup of a similar design alters fluid hydrodynamics and aeration which in turn can impact cell culture performance and product quality, according to Shenkman.
His conference presentation described a case study in which a legacy continuous process, utilizing a custom stainless steel bioreactor, was transferred to a single-use bioreactor. Inevitably the facility change resulted in changes to the processing and hydrodynamic environment of the cells, noted Shenkman, who added that both performance and product quality were impacted. This presented a risk to analytical comparability and necessitated a mitigation plan, he said.
Shenkman also addressed the question: What capabilities does continuous bioprocessing possess to modulate product quality to achieve analytical comparability? A continuous process, such as the one he described, allows one to analyze product quality throughout the run, i.e., a continuous bioreactor generates product-containing harvest day after day. A unit volume of harvest can be purified for product quality while harvest continues to be generated from the run. This means that while developing a continuous process the operating parameters can be changed and the effects evaluated during the same run. Further changes or corrections can be made without starting another run, he pointed out.
In this case study, a relationship was discovered between an operating parameter, cell density, and a number of critical quality attributes (CQAs). The relationship is dynamic such that increasing the cell density during a run moved CQAs of bioreactor harvests in one direction. Decreasing the cell density then moved CQAs of bioreactor harvests toward the other direction. “A continuous process allows us to measure successive responses to process perturbations in the classical sense,” he said.
The most expeditious path to mitigate the risk to analytical comparability at the new site was to revise the operating parameter range so that all CQAs in the receiving site returned to the historical ranges of the legacy sending site, continued Shenkman. So long as the cell density at the new site was maintained within an allowable range harvests could be purified to drug substance that satisfied legacy control limits and the risk of out-of-specification (OOS) results was low. The new control strategy was an important contribution to the success of the technology transfer, he said.
“I think that it was precisely because this was a continuous process that a control strategy could be devised to mitigate the risk to product quality at the new site in such a short amount of time,” he noted, adding that what applies to the standard panel of analytical methods also holds true for extended characterization.
“We performed metabolomic and proteomic analysis to get a deeper understanding of the impact of process changes on intracellular biochemistry. This being a continuous process, fresh medium and waste metabolites are continually perfused, so cell health remains high,” he explained. “The observations from extended characterization are thus more likely to be due to the parameter settings rather than the myriad other perturbations that occur in a fed-batch process.”
The extended characterization of this continuous bioreactor process revealed other process parameters that had the potential to increase productivity while maintaining product quality. “This was a very exciting result,” he said.
“Continuous processing is an enabler of improved process control, leading to higher product quality, which in turn should enhance patient safety,” says Peter Levison, executive director, business development, Pall Biotech.
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BIG NEWS on C_ART re NWBO’s DC VAX PlatformS
Why is it that over the last FIVE YEARS no one else ever posts:
1)IMPORTANT TRADE News???? or
2)discover NWBO’s vital link with Merck’s EVP Roger Perlmutter or
3)that of why no reported results with NWBO
Late 2016 Germany trial on Colorectal Cancer in combo with Merck
Sharp Dome??
Supposedly we have “scientifically minded” prolific high profile posters who follow one stock
while I’m a business minded investor limited TO ONE POST PER DAY!
CAR T cell therapy: On the cusp of 'an immunotherapy revolution'?
A deeper understanding of the immune system's role in controlling cancer has helped drive "an immunotherapy revolution," offering hope for many patients with previously incurable cancers, including children, doctors have concluded in a new report.
The assessment, from two Stanford University doctors, is part of their broader analysis on lessons learned from "the first leg of the CAR T cell journey."
CAR T cell therapy is a type of cancer treatment for cancers of the blood. The single-infusion treatment relies on a patient's own immune system cells to battle cancer.
Initial laboratory tests in the early 2000s, followed by hundreds of clinical trials, proved that recruiting key cellular soldiers from the immune system can fight cancer in a highly personalized way. CAR T, which involves supercharging T cells, is just one in a growing number of cancer immunotherapies that have shown how constituents of the immune system can be exploited beneficially.
Drs. Robbie Majzner and Crystal Macknall of Stanford University Medical Center assessed CAR T cell therapy based on clinical data that has been amassed to date.
Two CAR T cell drugs have been approved by the U.S. Food and Drug Administration: Kymriah (tisaglenlecleucel), a Novartis product, was given a green light in August, 2017, followed by Yescarta (axicabtagene ciloleucel) in October of the same year. Yescarta was developed by Kite Pharmaceuticals in California, a division of Gilead Sciences, Inc.
Kymriah was designed to treat B-cell acute lymphoblastic leukemia (B-ALL) in people 25 years old or younger whose malignancies have not responded to previous therapy. Yescata is aimed at adults with B-cell cancers that didn't respond to conventional treatment.
Hyperbole has accompanied the emergence of CAR T cell therapy, which has been hailed a "miracle" cancer treatment in some news stories because of the dramatic anecdotes this form of treatment has on some patients, especially children.
However, CAR T cell therapy, like any form of cancer treatment, is extraordinarily complex, as Majzner and Mackall underscored in their analysis, which was published in the journal Nature Medicine.
Some patients have a robust response to the infused therapy; others suffer relapses. Some forms of cancer, particularly solid tumors, do not respond as well to CAR T therapy as do cancers of the blood, but current drawbacks associated with CAR T cell therapy may not persist into the future, Majzner and Mackall contend.
"Disease histology has emerged as a major factor affecting outcomes after treatment with CAR T cells," Majzner and Mackall reported in the journal. Majzner is an assistant professor of pediatrics in the division of hematology and oncology. Mackall holds the title Ernest and Amelia Gallos Family Professor of Pediatrics and Medicine.
"Although the results of CAR T cells in solid tumors have not been as robust, several early signs of clinical efficacy in human trials hint at oncoming success," they wrote. "Further understanding of the factors influencing response and resistance are driving the development of next-generation CAR therapeutics that are predicted to mediate increased efficacy in both hematologic malignancies and solid tumors."
CAR T stands for chimeric antigen receptor T-cells. It is a form of cancer immunotherapy that involves bolstering a patient's T cells that are withdrawn in a blood sample. Some experts view CAR T treatment as cell therapy, gene therapy, and immunotherapy rolled into one.
After a patient's cells are withdrawn, they are primed in a laboratory to recognize and attack cancer through a genetic modification process that causes T cells to express a receptor on their surface. The special receptor is known as the chimeric antigen receptor, or CAR. The cells' receptor is engineered to bind to a protein on cancer cells known as CD19.
Once altered in the laboratory, the T cells are expanded into a small army, and then re-infused into the patient. Some doctors refer to the specially armed T cells as "living drugs," because they fight cancer around the clock.
In their assessment of previous studies, Majzner and Mackall found complete responses have been achieved in 60 percent to 93 percent of patients across several studies. Similarly, a 73 percent complete response rate has been found for pediatric patients with B-ALL when patients were administered a bioactive dose.
While CAR T therapy induces a high complete response rate in B-cell acute lymphoblastic leukemia, or B-ALL, Majzner and Mackall found in their analysis that longer-term follow-up assessment of patients "has revealed high rates of relapse that limit overall success."
In the cancer known as large B-cell lymphoma, or LBCL, CAR T treatment induces lower complete response rates, but relapses are rare, thus resulting in similar rates of long-term disease control as B-ALL, the doctors say.
CAR T-cell therapy, also known simply as CAR T, was pioneered by medical scientists Isabelle Rivière, Michel Sadelain and Renier Brentjens of Memorial Sloan Kettering Cancer Center in New York City.
ONE OF SIX MAJOR ONCOLOGY CENTERS SHARING INFO UNDER SEAN PARKERS(co founder of Facebook) CANCER FOUNDATION under CEO from UCSF(re NWBO early settled lawsuit by USCF respiratory nurse : Kimura?
The team's breakthrough discoveries led to clinical studies in the United States and elsewhere involving pediatric and adult patients. Both children and adults, as noted by Majzner and Mackall, have had robust remission rates in clinical trials without the need for additional treatment. That said, costs remain a concern for Kymriah and Yescarta. Both treatments are expensive. Kymriah runs about $475,000 for the single infusion; Yescarta costs about $373,000.
More information
Robbie G. Majzner et al. Clinical lessons learned from the first leg of the CAR T cell journey, Nature Medicine (2019). DOI: 10.1038/s41591-019-0564-6
© 2019 Science X Network
We will take that sensible LIGHTING BOLT along with AngeloFoca's BOLD RETURN as a TARGET to be REALIZED vs ALL the vicissitudeS of FRUITLESS pandering here since 2015!
:Chris said that LP told him (in effect) that she wouldn’t take anything less than $21 billion... he said they were talking about a $7 billion buyout of another company and he asked would she take that... her reply (as l recall) was ‘maybe three times that ‘... so l doubt she would consider $5 pps AND that coincides with her ‘go big or go home ‘ mantra... take it for what it’s worth to you...
The way I remember this is that the figure mentioned was $8 billion as opposed to $7 billion - thereby making her acceptable level $24 billion.
I have a dream - It's 95% likely just wishful thinking - but I am hoping that the lack of communication specifically regarding the manufacturing of Dc Vax L is actually a "quiet period" that NWBO has entered into due to negotiations for a buyout of the DC Vax L platform and perhaps "right of first refusal" for the DC Vax Direct platform down the road.
If they were to tell you that the technology for "L" manufacturing had been transferred to Merck... what would that shout out???
My dream is that all negotiations have been finalized and the only thing remaining is the buyout "price" - which is dependent on results once trial has been unblinded although guidelines are already set at say $5 billion with mediocre... but approvable results, $7.5 billion with favorable results, and $10 billion for stellar results... + 20% royalties + $2 billion for "right of first refusal" on DC Vax Direct.
So that one morning we wake up to news that the SAP has been submitted and accepted, AND that the trial has been unblinded and results are stellar, AND an offer has been made and accepted needing only shareholder's approval to be carved in stone... catching the shorts stone cold.
Rather be with the deranged flock's logic of getting the job DONE along with NOT losing $piles
It is fairly simple to see that if DI answered your question, he would get fired.
© 2019 InvestorsHub.com, Inc.
If Dave Innes talks about some grand plans for the manufacture of DCVax-L at this juncture, he will get fired. Better for him to keep silence
At this point in time this post by hyperopia IMHO covers ALL the bases
versus ALL others.
Thanks hyperopia for sharing.
Yet another Key nail in Woodford’s coffin: Largest Patient Capital holding is HALVED!:
So few were skeptical! Easily thousands of posts
Where are all the wagons of Pom Pom rooters from 2014 to May 2019?
Investing is only for those who are Ahead of the Curve:
The tech company is the biggest holding within Woodford Patient Capital — accounting for 9.81 per cent of the fund,
Fresh blow for Woodford over £270m holding
By Imogen Tew
A company in which Neil Woodford has a £270m holding is set to see its valuation slashed in another set-back for the embattled fund manager.
Link Fund Solutions has announced it will reduce the valuation of one of Woodford Patient Capital Trust’s holdings — a move which was expected to impact the trust’s net asset value by approximately 4p per share — though it has not named the holding.
It has since been reported, initially by The Sunday Times, that tech firm Benevolent AI — which features in both Mr Woodford’s Equity Income fund and Patient Capital trust — is to receive an investment from Temasek which halves the company's valuation and is therefore the unnamed holding.
Benevolent AI, of which former government minister Joanna Shields is chief executive, was valued at $2bn (£1.6bn) in April of last year but it is understood Temasek’s new investment ranks the firm at half this figure.
The tech company is the biggest holding within Woodford Patient Capital — accounting for 9.81 per cent of the fund, according to data from Hargreaves Lansdown — after Mr Woodford invested £76.1m in the firm.
Shares in the trust fell from £4.71 before the stock exchange notice to around £4.32 after it was issued but they have since bounced back slightly to around £4.50.
Just last month (August 23) investors in the trust faced another reduction in their investment when shares fell by 6 per cent over a revaluation of on of the trust’s unquoted holdings, IH International.
But recent data from the Association of Investment Companies showed advisers still backed the trust and thought the shares were a buy, despite suspicions over the true value of the underlying investments.
It showed the shares were trading at a discount to net asset value of 41 per cent — described as "seemingly chasmic levels" — and could therefore be a good investment.
Benevolent AI is also the sixth largest holding in Woodford’s suspended Equity Income Fund, accounting for 4.48 per cent of the fund with about £194m invested in the firm.
If the holding in question turns out to be Benevolent AI, it will reduce the value of the funds at a time when he is battling to sell hundreds of millions of pounds worth of shares to raise sufficient cash to open the fund and meet expected redemption requests from investors.
The fund was initially suspended for 28 days on June 3 following a period of sustained outflows of about £9m per working day in May but it has since been announced the fund will remain suspended until at least the beginning of December. Its authorised corporate director recently confirmed the fund had lost 11 per cent since June.
imogen.tew@ft.com[/quote]
Another Phenom Husband/Wife team on Vaccine for Alzheimer’s with close to 100% response & little side effects going for Ph3:
Bloomberg Businessweek
A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
United Neuroscience’s small Phase II trial appears to have overcome a decades-old hurdle.
By Ashlee Vance
For two decades, biotech companies trying to tackle Alzheimer’s disease have had little success. While vaccines have often shown promise for certain patients, they’ve come with devastating side effects for others—brain swelling, for example—because researchers haven’t been able to reliably keep patients’ immune systems from kicking into overdrive when exposed to the vaccines. Now, a four-year old Dublin startup believes it may be on to something.
To be clear, United Neuroscience Inc. hasn’t solved Alzheimer’s yet, nor has it claimed to. But previously unreported results from a small, recent United clinical trial show that 96 percent of patients responded, without serious side effects, to the Alzheimer’s vaccine the company calls UB-311. The patients demonstrated improved brain function and showed a reduction in the protein plaque gumming up their neurons, the company’s report says. “We are doing better than the placebo on all these things,” says Chief Executive Officer Mei Mei Hu. “We can’t make any claims yet, but we’re pointing in all the right directions.”
Alzheimer's by Age Group
Estimated number of people in the U.S. with Alzheimer’s disease
Data: American Academy of Neurology
While scientists aren’t sure what causes or exacerbates Alzheimer’s, there are several prime suspects: amyloid, a group of proteins that build up in the body over time and clump together in ways that wreak havoc on the brain; tau, another family of proteins with similar issues; and inflammation in general. United’s vaccine stimulates the patient’s own immune system to attack amyloid, which some researchers believe to be the leading cause. The vaccine’s job is to slow the proteins’ clumping and, if possible, reverse some damage and restore brain function.
United’s clinical trial, a Phase II study completed last year, tested the vaccine with a group of 42 patients who had mild cognitive impairment and appeared to be in the early stages of Alzheimer’s. One set of patients was in the control group and received a placebo, while two other groups received three shots of the vaccine and then boosters either every three or six months over the course of a year and a half.
Although the small number of patients prevents United from drawing any major statistical conclusions, the company has been encouraged enough to move ahead with development of the vaccine, possibly with a larger partner, according to Hu.
relates to A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
Hu and her husband, Lou Reese, have spent about $100 million on vaccine R&D over five years and are looking for more funds.PHOTOGRAPHER: BOBBY SCHEIDEMANN FOR BLOOMBERG BUSINESSWEEK
“They claim to get around the immune response, and it looks like they have been successful,” says Frank Longo, chairman of Stanford’s neurology department and co-founder of Pharmatrophix Inc., which is also trying to cure Alzheimer’s. “So that’s good.” United says it’s spent $100 million so far on vaccine research and development.
Hu, 35, has a résumé that reads part Ivy League all-star and part industrious hippie. She’s a Harvard-trained lawyer who practiced at Cravath, Swaine & Moore, consulted for McKinsey & Co., then left to start an organic farm and solar power company in Hawaii with her husband, Lou Reese, a 37-year-old real estate developer. They ran the farm for a couple of years, watching YouTube videos to figure out how to, say, slaughter chickens, before expanding the family circle with their latest venture.
“My mother-in-law actually invented something that Harry Potters your balls and makes them disappear”
Hu’s mother, Chang Yi Wang, is United’s chief scientific officer and was the inspiration for starting the company. Wang has spent decades developing medical treatments and vaccines, including an affordable blood-screening kit for people in developing countries, as well as a vaccine that protects animals against foot-and-mouth disease and another that chemically castrates male pigs to keep their meat tasty and marketable. The vaccines have proved so effective at keeping pigs healthier that they’ve been used on billions of animals in China, Mexico, Brazil, and Russia. “My mother-in-law actually invented something that Harry Potters your balls and makes them disappear,” says Reese, who’s prone to gesticulate and toss his hair while Hu remains measured and direct. “The intensity of that as a son-in-law is unbelievable.”
The family’s big realization was that the same technology breakthroughs that made the animal vaccines work so well could likely be applied to humans. Hu and Reese persuaded Wang to give the research a go and lent their business expertise to taking her ideas out of the lab and into the field.
relates to A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
Yet targeting amyloid alone, without trying to control tau or inflammation, remains controversial, says Stanford’s Longo. “Any therapy centered on going after amyloids is dependent on how accurate the amyloid hypothesis is, and that hypothesis continues to be questioned,” he says. Also in the minus column: People using UB-311 would ideally start treatment before they showed symptoms and then receive a dose every six months. It’s not a one-shot deal, and physicians can’t confidently predict who will get Alzheimer’s and dementia.
For now, United says it’s focused on raising capital to fund a more conclusive UB-311 study and to keep refining its widening range of vaccines. The 35-person company is gearing up to start trials of UB-312, aimed at Parkinson’s disease, and a second Alzheimer’s vaccine meant to combat tau. “They have taken thoughtful initial steps with this very promising technology,” says Eric Reiman, a leading Alzheimer’s researcher and an adviser to United Neuroscience. “But this is still the beginning of the beginning.”
BOTTOM LINE - United needs a bigger sample size for its next Alzheimer’s study, but the latest one appears to have successfully targeted suspect proteins without any serious side effects.
XenaLives Member Level Monday, 09/16/19 11:47:18 PM
Re: maverick_1 post# 210109 0
Post # of 210110
FAKE NEWS..
So much error that it's not funny.
Respond | No replies
Bloomberg Businessweek
A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
United Neuroscience’s small Phase II trial appears to have overcome a decades-old hurdle.
By Ashlee Vance
January 16, 2019, 3:00 AM PST
A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
United Neuroscience’s small Phase II trial appears to have overcome a decades-old hurdle.
By Ashlee Vance
For two decades, biotech companies trying to tackle Alzheimer’s disease have had little success. While vaccines have often shown promise for certain patients, they’ve come with devastating side effects for others—brain swelling, for example—because researchers haven’t been able to reliably keep patients’ immune systems from kicking into overdrive when exposed to the vaccines. Now, a four-year old Dublin startup believes it may be on to something.
To be clear, United Neuroscience Inc. hasn’t solved Alzheimer’s yet, nor has it claimed to. But previously unreported results from a small, recent United clinical trial show that 96 percent of patients responded, without serious side effects, to the Alzheimer’s vaccine the company calls UB-311. The patients demonstrated improved brain function and showed a reduction in the protein plaque gumming up their neurons, the company’s report says. “We are doing better than the placebo on all these things,” says Chief Executive Officer Mei Mei Hu. “We can’t make any claims yet, but we’re pointing in all the right directions.”
Alzheimer's by Age Group
Estimated number of people in the U.S. with Alzheimer’s disease
Data: American Academy of Neurology
While scientists aren’t sure what causes or exacerbates Alzheimer’s, there are several prime suspects: amyloid, a group of proteins that build up in the body over time and clump together in ways that wreak havoc on the brain; tau, another family of proteins with similar issues; and inflammation in general. United’s vaccine stimulates the patient’s own immune system to attack amyloid, which some researchers believe to be the leading cause. The vaccine’s job is to slow the proteins’ clumping and, if possible, reverse some damage and restore brain function.
United’s clinical trial, a Phase II study completed last year, tested the vaccine with a group of 42 patients who had mild cognitive impairment and appeared to be in the early stages of Alzheimer’s. One set of patients was in the control group and received a placebo, while two other groups received three shots of the vaccine and then boosters either every three or six months over the course of a year and a half.
Although the small number of patients prevents United from drawing any major statistical conclusions, the company has been encouraged enough to move ahead with development of the vaccine, possibly with a larger partner, according to Hu.
relates to A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
Hu and her husband, Lou Reese, have spent about $100 million on vaccine R&D over five years and are looking for more funds.PHOTOGRAPHER: BOBBY SCHEIDEMANN FOR BLOOMBERG BUSINESSWEEK
“They claim to get around the immune response, and it looks like they have been successful,” says Frank Longo, chairman of Stanford’s neurology department and co-founder of Pharmatrophix Inc., which is also trying to cure Alzheimer’s. “So that’s good.” United says it’s spent $100 million so far on vaccine research and development.
Hu, 35, has a résumé that reads part Ivy League all-star and part industrious hippie. She’s a Harvard-trained lawyer who practiced at Cravath, Swaine & Moore, consulted for McKinsey & Co., then left to start an organic farm and solar power company in Hawaii with her husband, Lou Reese, a 37-year-old real estate developer. They ran the farm for a couple of years, watching YouTube videos to figure out how to, say, slaughter chickens, before expanding the family circle with their latest venture.
“My mother-in-law actually invented something that Harry Potters your balls and makes them disappear”
Hu’s mother, Chang Yi Wang, is United’s chief scientific officer and was the inspiration for starting the company. Wang has spent decades developing medical treatments and vaccines, including an affordable blood-screening kit for people in developing countries, as well as a vaccine that protects animals against foot-and-mouth disease and another that chemically castrates male pigs to keep their meat tasty and marketable. The vaccines have proved so effective at keeping pigs healthier that they’ve been used on billions of animals in China, Mexico, Brazil, and Russia. “My mother-in-law actually invented something that Harry Potters your balls and makes them disappear,” says Reese, who’s prone to gesticulate and toss his hair while Hu remains measured and direct. “The intensity of that as a son-in-law is unbelievable.”
The family’s big realization was that the same technology breakthroughs that made the animal vaccines work so well could likely be applied to humans. Hu and Reese persuaded Wang to give the research a go and lent their business expertise to taking her ideas out of the lab and into the field.
relates to A First Step for a Family Biotech’s Vaccine Against Alzheimer’s
Yet targeting amyloid alone, without trying to control tau or inflammation, remains controversial, says Stanford’s Longo. “Any therapy centered on going after amyloids is dependent on how accurate the amyloid hypothesis is, and that hypothesis continues to be questioned,” he says. Also in the minus column: People using UB-311 would ideally start treatment before they showed symptoms and then receive a dose every six months. It’s not a one-shot deal, and physicians can’t confidently predict who will get Alzheimer’s and dementia.
For now, United says it’s focused on raising capital to fund a more conclusive UB-311 study and to keep refining its widening range of vaccines. The 35-person company is gearing up to start trials of UB-312, aimed at Parkinson’s disease, and a second Alzheimer’s vaccine meant to combat tau. “They have taken thoughtful initial steps with this very promising technology,” says Eric Reiman, a leading Alzheimer’s researcher and an adviser to United Neuroscience. “But this is still the beginning of the beginning.”
BOTTOM LINE - United needs a bigger sample size for its next Alzheimer’s study, but the latest one appears to have successfully targeted suspect proteins without any serious side effects.
Dr Bala re:
What are you talking about? Last week I celebrated my 49th birthday at Ruth Chris. Of course, I couldn't get anyone to believe that I was 49.
Note: If NWBO is successful (I am convinced it will be), I will retire.
Dr. Bala re:
LP owns over 137 million shares. If there is a b/o, she will no doubt be a multi-billionaire. She has more at stake than any of us.People who post non stop totally IGNORE reality because they are daily price FIXATED and their INSECURITIES are on DISPLAY... some even to patch up their big fumbles
Well, I have something at stake too. If the b/o price is high enough, I can retire and do some traveling. FINALLY we are approaching journey's end: nearing Top Line........ and A NEW dawn is arriving to open up a NEW CHAPTER for ALL!
Fortunately it does not appear that BrEXIT will have a noticeable impact given Cognate mfg in both MemphisTN USA and Sawston UK
UNLIKE what Cancer Research UK indicates in this exclusive article:
Exclusive
Brexit delay to lifesaving cancer treatment ‘will hit children hardest’
Leading cancer charities have expressed their alarm that a no-deal Brexit could have a grave impact on ‘lifesaving research’ to treat childhood cancers.
It comes after the publication of the government’s Yellowhammer papers, which warned that medicines would be ‘particularly vulnerable to severe delays’ in the event of Britain crashing out of the EU without a deal.
The documents also highlighted that ‘three-quarters of medicines’ come from the EU.
Cancer charities are now calling on the government to take steps to ensure the ‘supply of medicines and lifesaving research’ which are so vital to treating children’s cancers, are not harmed by a no-deal Brexit, after Boris Johnson reaffirmed his commitment to leaving the EU with or without a deal on October 31.
Cancer research UK says that more than a quarter of the clinical trials that it funds involved at least one other EU country, which are ‘particularly important for rare and children’s cancers’.
The charity’s head of policy, Emlyn Samuel, told Metro.co.uk: ‘It’s imperative that a “no-deal” Brexit does not disrupt the supply of medicines and medicinal products to the UK, or threaten vital international research collaboration.
‘More than a quarter of the clinical trials that Cancer Research UK funds involve at least one other EU country, and these are particularly important for rare and children’s cancers.
‘The Government is putting contingency plans in place to minimise disruption. But despite these measures, the scale of this challenge means that some risks inevitably remain.
‘Whatever the outcome on 31 October, the Government must take action to ensure that people with cancer are protected.’
Children with Cancer UK has echoed those calls and is calling on the government to prevent any damage to ‘essential lifesaving research’ which is ‘vital to improving survival rates’.
Acting CEO Mark Brider said: ‘Like most medical research charities, Children with Cancer UK works closely with European counterparts to research and develop new and better treatments.
‘Childhood cancers are very different to those found in adults, but all too often doctors have to rely upon treatments designed for adults.
‘This can leave children facing lifelong health problems as their small bodies struggle to cope with toxic medicines.
‘Research into childhood cancer is vital to improving survival rates as well as quality of survival for the 4,500 children and young people diagnosed with cancer in the UK every year.
‘Whilst we don’t yet know what the full impact will be on new and ongoing studies, we would be concerned if a no deal Brexit caused significant delay to this essential lifesaving research.’
Got a story for Metro.co.uk?
Get in touch with our news team by emailing us at webnews@metro.co.uk. For more stories like this, check our news page.
Not surprised when litigiousness trumped by NO Balance in Legal Strategy:
The 16 other states likely will get a small fraction of their filings for damages IMHO!
I sensed for years that the astute Sackler’s funneled their largess into secret tax havens!
Such is just one of many examples of The EXTREMES of our Capitalist Society on
Pilfering the Masses and wrecking their respective markets to Natural Disasters and
HOW can one recover??? seen worldwide due to ACCELERATED Climate Change!
RESULT :
Purdue Pharma Seeks Bankruptcy to Short-Circuit Opioid Suits
Jef Feeley and Steven Church
(Bloomberg) -- Purdue Pharma LP filed for bankruptcy with a more than $10 billion plan to settle claims that it fueled the U.S. opioid epidemic by illegally pushing sales of its addictive OxyContin painkiller.
The Chapter 11 filing on Sunday in White Plains, New York, is designed to short-circuit more than 2,000 lawsuits against Purdue and its owners, the billionaire Sackler family. The settlement calls for the Sacklers to hand over Purdue to a trust controlled by the states, cities and counties that have sued to recoup billions of dollars they spent battling opioid addictions and overdoses.
Officials originally envisioned raising as much as $12 billion with the plan, which is backed by more than two dozen U.S. states and territories, along with many cities and counties that sued Purdue. In an emailed statement TKTK, Purdue officials reduced the potential settlement amount to more than $10 billion.
The Sacklers have guaranteed to pay a minimum of $3 billion as part of the settlement, with most of the sum generated by selling Purdue’s U.K.-based drugmaker Mundipharma.
The family has rejected calls by some state attorneys general to boost their payment to $4.5 billion, and almost 25 states are opposing the family’s settlement offer. States that aren’t satisfied with Purdue’s proposal will get a chance to voice their opposition before a bankruptcy judge approves its Chapter 11 plan.
The plan calls for Purdue officials to set up a trust responsible for operating the company, which would generate money that governments could use to bolster drug treatment and policing budgets. That entity, run by trustees appointed by a bankruptcy judge, also will oversee payouts to state and local governments that sued.
“This unique framework for a comprehensive resolution will dedicate all the assets and resources of Purdue for the benefit of the American public,” Steven Miller, the drugmaker’s board chairman, said in an emailed statement.
Bigger Bite
Opponents argue Purdue’s plan isn’t enough of a reckoning for the Sacklers, who made billions from the over-prescribing of OxyContin that was spurred by the company’s allegedly illegal marketing. It also won’t provide enough reimbursement for hundreds of thousands of overdose deaths and addiction damage inflicted on millions of U.S. families, opponents say.
“Irrespective of Purdue’s actions or evasions, we will continue to pursue justice on behalf of those harmed by the Sacklers’ greed, callousness, and fraud,” Delaware Attorney General Kathy Jennings said in an emailed statement.
The Sacklers and Purdue officials had hoped to persuade 35 attorneys general to back the current settlement proposal. That super-majority would have held more sway with a bankruptcy judge when it came time to win final approval of the deal. As of Sunday, the company said it had the support of as many as 29 U.S. states and territories, according to the release.
Purdue planned to file for protection from creditors by the end of September to avoid facing a Cleveland jury that’s scheduled to hear evidence starting next month in the first federal trial over the opioid epidemic.
Public Nuisance
A host of other opioid makers, such as Johnson & Johnson, and drug distributors like McKesson Corp., will face claims they created a public nuisance across the U.S. with their mishandling of the medicines.
States and municipalities contend drugmakers, distributors and pharmacy chains conducted illegal marketing campaigns pushing the painkillers, failed to adequately oversee orders and ignored red flags about unusually frequent retail sales.
In March, Purdue settled claims brought by the state of Oklahoma for $270 million, and another defendant, Teva Pharmaceutical Industries Ltd., also reached a, $85 million deal to avoid trial. J&J, which refused to settle, was ordered to pay $572 million for creating a public nuisance in the state with its over-promotion of its opioid pain medicines.
--With assistance from Dawn McCarty.
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net;Steven Church in Wilmington, Delaware at schurch3@bloomberg.net
To contact the editors responsible for this story: Rick Green at rgreen18@bloomberg.net, ;David Glovin at dglovin@bloomberg.net, Virginia Van Natta
FULL DISCLOSURE:
Before OxyContin, I worked with Dr. Richard Sackler for months successfully as an entrepreneur on changing residential real estate zoning in an elite town.
There is really NOTHING that is not ALREADY DISCLOSED per the Last TWO Annual Shareholders Meeting as to your conversation with VP David Innes:
1) Would CEO accept a Buyout OFFER
The fact that so many have been Totally UNAWARE says to any logical mind that one only pays attention to what they want to hear like when SAP and all the paraphernalia surrounding it at the EXCLUSION of all else that CEO Linda Powers STATES. Same for what SVP Les Goldman and other Board Members like Jawonoski?
For a THOUGH read with supporting documentation see:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148898295
https://investorshub.advfn.com/boards/replies.aspx?msg=148898295
2) MB’s do UNDERMINE a CEO like Linda Powers in Pied Pipers leading their flock way too often ASTRAY and sometimes for slaughter versus The CEO who has her pulse on every VITAL issue facing NWBO.
3)Few, if any, BEFORE May 2019 had a clear idea of GETTING Your NWBO shares OUT of Street Name and INTO YOUR NAME
!
ALL of these two Annual Shareholder Meetings have been transcribed: the last one by IkeEsq!
So it is not possible that any of my remarks are mere inferences but instead THE ONLY INTERPRETATION that lots of posters have run AFOUL of the Ground Rules of Investing by giving
DEFERENCE to non transparent Pied Piper PUNDITS since 2015!
Mutiny on the Bounty is RARELY ever successful:
I DID ONE on FIRST try:
NO experience!
And in record time!
Lots of folks here on a non stop carousel by NOT focusing on the mindset and what CEO Linda Powers
Has STATED in it’s ENTIRETY versus what we see here in dribs and drabs! and mostly here say without expert corroboration let alone links!..... preferring instead to the growing infectious metastasis here
iwasadiver Photonic5; and AlphaPuppy have been the KEY DRIVERS here!
Thanks to iwasadiver who BEGAN the simmer to a boil NOW re Dr. Kevin Duffy hire from Merck as an upstream VITAL agent for our NWBO completing this VITAL phase for unlocking the full potential commercialization and value of NWBO's DC VAX PLATFORM.
This penny trading doesn’t really interest me. I believe in the product and I believe NWBO’s worth is over $20 billion with positive topline data
NVCR Insider Selling is NOT significant YET as some grandstanding posters make it out to be as the TOTAL picture is HERE:
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=13353947&RcvdDate=4/10/2019&CoName=NOVOCURE%20LTD&FormType=DEF%2014A&View=html
ALSO:
IF NWBO is successful MAYBE get a real WHALE compared to ALL the minnow posts
here on NVCR which have NO REAL RELEVANCE in the REAL world versus what some would like to promulgate for their own aura along with clear deflections diversions:
As of March 19, 2019, our records and a review of relevant SEC filings indicated that the following shareholders were the beneficial owners of more than 5% of our Ordinary Shares.
Name of Beneficial Owner
Number of
Ordinary Shares
Beneficially Owned
Percent
FMR LLC (1) 11,190,380 11.7%
Hansjoerg Wyss (2)9,954,748. 10.4%
The Vanguard Group (3) 6,418,9656.7%
Gert Lennart Perlhagen (4)
REAL TIME NET WORTH
$6B
as of 6/29/19
Hansjoerg Wyss' fortune stems from his 2012 sale of medical device manufacturer Synthes, which he founded, to Johnson & Johnson for $20.2 billion.
He now holds stakes in publicly-traded biotech companies NovoCure and Molecular Partners.
[t][/t]Blue_Skies re:
@Poor Lack of management credibility is an issue to the investment community and is one reason people (pharma) does not take the Dcvax product line seriously. Too many innuendos with no follow through. Eventually the company will either release unblinded results which support FDA approval or the company goes BR. Currently the company does not have much money.
Just my thoughts
BWIS re:
Maverick does this 911 share trade really mean anything?
Photonic5; AlphaPuppy AND iwasadiver have been the KEY DRIVERS here!
re:
This penny trading doesn’t really interest me. I believe in the product and I believe NWBO’s worth is over $20 billion with positive topline data.
FINALLY an IntraDay by Sojourner re:
Yeah, the 2 - 3:30 shakeout has started like yesterday.
Hbpainter re:
It's a long story!!
Basin Street Blues Member Level Monday, 08/04/14 10:30:18 AM
Re: None
Post #
16524
of 244109
HI Everyone,
Some true statements:
1. DCVAC / L: Phase 1, Phase 2 great results, anecdotal evidence everywhere and well into P3 trials.
2. PEI approval, German government reimbursement even for non Germans! Almost definite evidence that FDA shared info with Germany.
3. DCVAC / D: Superb early results 9 out of 9 etc etc.
4. NWBO Huge presence at ASCO , major PR event to the industry professionals
5. Evaluate Pharma: Rank us 7th most important R&D in the word with the 6 above us all owned / aligned with major Pharma...
Seeing as all of the above is in the public domain WHY is our Institutional ownership less that 10%? (btw PUMA was above 80%).
NWBO is owned on the whole between LP and retail (that’s us) …she has no institutions to rely on and NW cannot suggest `its early days and they don’t know about what NW have been up to` ... The truth we must face up to is they looked and have simply passed on buying our shares ….and they know more than all of us put together about their industry .
We have invested in and lived with a company that kept the PR`s coming and built a relationship with its retail based on that …. but now its stopped …so..
Conclusion (for me at least): The next PR has to be substantive, irrefutable, NO double entendres or I`M OUT … I am currently long 196k shares
maverick_1 Monday, 08/04/14 02:58:03 PM
Re: Basin Street Blues post# 16524
Post #
16545
of 244109
BASIN ST BLUES NWBO is institutionally BLIGHTED, ignored for the most part because/b]:
1. The two comparable public co's BLEW IT:
FOREMOST is DNDN's COLOSSAL FAILURE As the ONLY FDA immunotherapy cancer RX approved for Prostate Cancer (PC) AND the company really screwed up in terms of difficulty of application; has to be done by a special facility requiring trained personnel.More importantly they could not scale up mfg hence their pdtn costs went thru the roof. Also the FDA made them do another clinical that resulted in more delays. As this was happening both JNJ and MDVN got their PC drugs approved and since their pdt costs were lower did NOT run into serious reimbursement issues like DNDN. Many physicians went to JNJ & MDVN PC drugs because they cost less and those are pills vs that of DNDN. To add further insult to injury the CEO Mitch Gold WAY OVERFORECASTED demand and UNDERESTIMATED mfg costs (THE KEY)and PILED on DEBT. THREE STRIKES HERE. When he finally realized that all these key variables and the fact that JNJ & MDVN were beating him he finally did a MAJOR REVERSAL: TWO LARGE SCALE CUTBACKS! He resigned.THAT WAS ONLY TWO YEARS AGO so still fresh in Institutional Mindset IMHO And the CEO who followed him is LEAVING. When the stock was $5 not to long ago, I literally said to myself: it's going chapt 11 because who would want to buy it!The whole DNDN extreme roller coaster and MGT royally screwing up is the most PROMINENT reason why NWBO has low instl ownership
IMUC reported very disappointing PH2 results last Dec '13 and shares got slammed
.Institutions look just superficially on the surface of NWBO without clearly understanding the draconian differences that I underscored in some of my earlier posts: the LP interview describing the strategic differences of how NWBO does it vs DNDN 1)
Here's the post containing CEO Linda Powers views (4 yrs ago but still RELEVANT! of why NWBO is so vastly different than DNDN which institutions likely have not read or shelved till a DEFINITIVE announcement takes place:
maverick_1 Member Level Saturday, 07/12/14 11:18:54 AM
Re: longusa post# 15464
Post # of 16543
Elaboration on DNDN strategic flaws from CEO!
Much thanks LongUSA for yet another elucidation to ramify and reinforce/add to LP's interview.
IMHO time for a much needed refresher course.
Copied and pasted below in it's entirety:"straight from the horse's mouth" BioMedReports Interview:
maverick_1 Member Level Saturday, 07/12/14 11:18:54 AM
Re: longusa post# 15464
Post # of 16543
Elaboration on DNDN strategic flaws from CEO!
Much thanks LongUSA for yet another elucidation to ramify and reinforce/add to LP's interview.
IMHO time for a much needed refresher course.
Copied and pasted below in it's entirety:"straight from the horse's mouth" BioMedReports Interview:
WORTHY OF A BOOKMARK; STICKY as it is WHY NWBO HAS SUPERIOR TECHNOLOGY as well as a fraction of the cost vs that of clearly dethroned and nearing extinction (DNDN's Provenge):
Cancer Vaccines: Northwest Biotherapeutics -vs- Dendreon
By M.E.Garza
Thursday, 15 July 2010 04:59
1
As a follow up to our interview with Northwest Biotherapeutics’ (NWBO.OB) Chairman of the Board of Linda Powers, this article focuses on the “hard differentiators” between NWBO’s immunotherapy vaccine platform and that of their closest competitor Dendreon Corporation (Nasdaq: DNDN).
Observers and investors of Northwest Biotherapeutics now believe the company’s DCVax® may be poised to surpass Dendreon’s product in the field of vaccine based cancer treatments. Speculators have begun to rush back to pick up shares of NWBO just as sector darling Dendreon Corp. (NASDAQ: DNDN) has lost 44% of its value after news that Dendreon can only make enough of their recently approved prostate cancer drug to treat about 2% of eligible patients.
First factor: The quality and characteristics of the antigens used by both companies in their vaccines
Dendreon uses PAP, while NWBO uses PSMA. Terminology aside, what matters here according to representatives at NWBO is Dendreon’s target antigen is not expressed on all prostrate cancers. They have to screen their patients to see the expression of their target. NWBO’s target antigen is expressed on all prostrate cancers. Additionally, with Dendreon’s target, the level of expression goes down as the cancer progresses. The level of expression on NWBO’s target goes up as the cancer progresses. As we learned from NWBO’s Chairman Linda Powers, if your target is getting harder and harder for the vaccine to find and hit as the cancer progresses, that’s not the characteristic you want in your target antigen.
Another difference in the target antigens is NWBO’s target is bound to the membrane of the tumor cell. “If the DCVax® hits our target,” explains Linda Powers, “it hits the cell for sure. Dendreon’s target is secreted by the cell, so while the target is close by, it is not necessarily bound to the cell in every instance. Antibodies can come along and glom onto to the target and not hit the cell itself, which means accuracy is an issue.
Second factor: The manufacturing and purity of the product
The active ingredient in both companies’ vaccines is dendritic cells. That is an active pharmaceutical ingredient, it’s the active agent that’s doing the job. But according to data provided by Northwest Biotherapeutics, the percentage composition of Dendreon’s product by the company’s own published material is 15% antigen presenting cells -- dendritic cells and others. According to NWBO’s published material, DCVax® is over 80% active ingredient. The official product release criteria are over 80% and Northwest Biotherapeutics’ platform usually hits over 90%, thus the active ingredient in NWBO’s vaccine is much more concentrated.
Third factor: How is the product administered to the patient
According to Powers, because there is such a low percentage of active ingredient in Dendreon’s vaccine, they have to deliver a huge volume, and the only way to do it is intravenous infusion, which is how they deliver Provenge to their patients.
This IV delivery can take over an hour. By contrast, because the active ingredient is so concentrated in the DCVax® vaccine, NWBO only needs to administer a tiny volume of “just a few drops” and it’s administered with a simple injection under the skin, like a flu shot or insulin shot.
As is the case with most medications, where and how a vaccine is administered has a big effect on how well the vaccine can do its job once it’s put into patient’s body. The human body has a blood circulatory system and a lymph circulatory system which is separate and parallel. Dendritic cells do their job in the lymph system, in the lymph nodes.
UNLESS mgt has previously demonstrated a successful record of succeeded in securing FDA approval and operating profitably with
expected revenues, or that mgt has sold a successful enterprise, biotech mgrs require at the very least some clear but DEFINITIVE
INDICATIONs (ie L Efficacy; GBM reimb.terms/revs from Germany) before taking on a position of an unknown like NWBO.
They don't need to be a hero as there is a lot of fish to fry in the biotech space.
THE ABOVE IS JUST ON THE FUNDAMENTAL SIDE
WHEN institutions have the above in place meaning some or all of the DEFINITIVE indications Announcement then...
How can I get SIZE w/o affecting price(typically only at a secondary)as they would normally like to avoid the open market since the float is thin.
If you'd like to sell suggest you contact Les Goldman who may set you up with a buyer: that would be good for EVERYONE IMHO!
GL Basin Stret Blues
PM me if needed.
Drugrunner re:
Yes but having 99% of your previous posts having $NWBO on blast doesn’t serve the company or the share price well at all.
Most in hindsight believe there to be a method to this madness that LP, LP, LES, et al have perpetuated these past few years
LESS IS MORE, as far as guidance and now we THINK we might be in the HEINZ red zone about to score.
Linda I believe plans to drop ALL THE NEWS in a very small window and dry all the naysayers and holler SCOREBOARD
jdheart101 Member Level Thursday, 08/08/19 10:30:31 AM
Re: None Post # 238927 of 244103
There she goes on her way to $0.11 and the big fat one for a hundred reverse split
jdheart101 Member Level Wednesday, 08/07/19 04:23:56 PM
Re: None Post # 238851 of 244103
huge reverse split coming that will wipe out all equity when it is shorted down to pennies but it will allow LP & co to continue on for years, kinda like the last one
jdheart101 Member Level Sunday, 08/14/16 02:43:40 PM
Re: None Post # 69839of 244103
NWBO HAS HIT BOTTOM!!!!! MARK IT
INSIDER SELLING is clearly NOT CONCLUSIVE: this is the BEST reasoning explained by eboomer2611:
On your other question - in terms of insider sales, I would say almost 90%+ it would be misleading to view it negatively. There are so many reasons for sales that retail investors just dont really understand as well (tax sales, 10b-1 plans, just normal diversification, liquidity need, etc). In my experience, if an insider truly felt the stock was going to head down or something bad was coming, most prudent Exec wouldnt sell because they wouldnt want the risk or stress that it might look like they were acting on information. Most Execs at mid to large companies are conservative / risk averse and they aren't trying to optimize stock sales and would rather hold than cause any risk on themselves by trying to cash out before bad stuff happens. The other consideration that I see frequently is that Execs are generally recommended to put 10b-1 plans in place by their legal advisors, financial advisors, etc. So in many instances even if they werent think of at least having a plan that takes some stock off over time, they would be highly advised to do so as best practices for them. So again I wouldnt read much into 10b-1 plans as it's just a best practice whether your bullish, bearish, or neutral and what prudent management does.
Keep in mind most Exec and Directors do have ownership requirements so they do need to hold at least a certain multiple of their compensation to ensure alignment (and that is why when it looks like some people sold everything chances are you aren't seeing their full equity considering unvested and milestone triggered, etc). In terms of suspending a 10b-1 plan. I do think you can suspend but I think it might be tricker to just restart it again so you have to be careful suspending it as you can only put a plan in place where you are in an open period with no issues and with a company like amrn that could be once or twice a year so if they suspend it may be very tough to restart it (as you can't just turn it back on when you want as that could be unfair and I think same thing with suspend - you may have to suspend when you are in an open period as well - not positive on that).
In terms of what would worry me. If all of a sudden JT sells a large part of his holdings (30% plus) at one time. I dont follow much of some of the other management as they have smaller positions and the value might be transformative for their lives that they are more inclinced to sell just out of prudence. While JT has so many shares, there really isnt a reason for him to sell a very signficant block as these smaller % sales gets him a lot of cash. If someone is cashing out $30M in one transaction you start to worry unless they have some huge need personally (which hard to imagine what is that big). I'd be more worried on Baker Bros making a large sale (it can be argued similalry they might not be bearish and just taking profits - but it would make me anxious because I assume their DD is better than mine)
The other item I'll mention that I think is unfair on insiders. We keep hearing "Oh look JT sold at the high again blah blah". In my experience, management that has signficant shares arent sitting there like us trying to get the best price or time their shares (if its a legit comopany and management). They value liquidity at a specific point of time versus what the exact price is. They are not losing sleep if they sold at 16 and its 20 a day later (honestly they are just happy to get a shot of liquidity and they have density of position so every sale is going to be good for them) The 10b-1 plans have set timing every month, quarter, or frequency, etc. They are not picking the day the price happens to be high or whatnot. That is all being managed outside of them. In addition, I can tell you no good exec that doesnt want to take enormous risk of serious trouble cares to create a buy out rumor ahead of a planned sale - that is way stupid. That is just dumb conspiracy theory and I think we all know that AMRN management is conservative. Also, management has their eggs in one basket often, but when the company does well they do REALLY well so unlike us investors that want / need as high of price as possible, in my experience insiders are not as senstitive to their sale price as we are and again just focused on getting liqudiity at regular intervals and care more about the long term trend of the stock the specific price they get on any sale.
jessellivermore Member Level Friday, 06/28/19 06:45:04 AM
Re: eboomer2611 post# 198863
Post #
198876
of 214201
eboomer...
Thanks for this very informative explanation/discussion of insider selling...This is very pertinent when it comes to biotechs because in many cases biotech management stock shares or options are a portion of their salary...Also management should not be criticized for not buying shares if they are receiving stock as a portion of their salary as selling shares to buy more shares generally does not make sense...
":>) JL/quote]
ELEMENTARY
Same OLE refrain: Another Chorus more?:
Basin Street Blues Member Level Monday, 08/05/19 04:24:54 AM
Re: flipper44 post# 238514
Post #
238525
of 244100
Flipper,
Take a look at this chart it shows Green for insider buys and Red for insider sells ..
So ordinarily if you were a HF who punted around in this stuff you`d look for two companies in the same sector as you`d get automatic protection from macro movements, so you`d sell NVCR and buy NWBO but you wouldn't because
if you even suggested to your compliance & risk department to buy an
OTC penny stock with zero transparency and a record for using shareholders like a U bend you'd get an immediate `NO` and more importantly your credibility as a PM would be in tatters.
Whatever the real driver behind radio silence from LP by definition it hasn't worked we are at 21 cents and still diluting .
So should anyone at NWBO tells you the silence plan is to `Scupper Mr Shorty ` at best they are being disingenuous and worst lying manipulators.
[Suppressed Image]
CalMustang with specific reference to:
WHY hasn't the OPTIONS Expert here NEVER forewarned of the impending DELUGE??
NONE of this has surprised me: saw it happen with NWBO back in Fall 2015!
Is there a MOLE here??
Today Technicals IMPROVED: Point + Figure Charting: TRIPLE Top BREAKOUT
See: Bottom Chart: https://stockcharts.com/freecharts/gallery.html?amrn
THIRD consecutive UP day with each day having comparable volume:
AMRN has not seen this since early July 2019! before it peaked out at $23-$24!
Sharp Chart:
Everything going along with yesterday's positive indicators are improving
Bollinger Bands over last three + trading days are narrowing with UPWARD Bias and at the top end!
Fast Stochastics is a good early indicator and DID experience a reversal from previous downward trend measured at 10 scale Aug 12 is NOW at 89!
AMRN might see a profit-taking pause like AMRN saw intraday Thursday at $17.10 (sell-off last FOUR hrs) so that will be short term resistance.
Good EARLY signs of beginning reversal? in ADX Plus.
DEATH Cross still intact as 50 DMA (remember because it is a Moving Average as long as stock price
increases it helps BUT takes time: UNLESS substantive AMRN Press Release)
So continues to IMPROVE!
CalMustang and JL
HAS it ever crossed your mind what I have felt eerily for months since the decline from $23:
WHY hasn't the OPTIONS Expert here NEVER forewarned of the impending DELUGE??
NONE of this has surprised me: saw it happen with NWBO back in Fall 2015!
Is there a MOLE here??
Came across this 4-5 yr old post of mine that has relevance here re Steve G:
with respect to my conclusion that Pyrrh(Steve Giardino in LI (really outside Syracuse, NY): good at spinning vs being home contractor) is the author behind V Phase V Research.
Colorectal Cancer is the SECOND most deadliest cancer: Follows WHY CEO Linda Powers targeted GBM FIRST (deadliest) and then late 2016 the Merck Sharp Dome PH2 colorectal cancer trial which IMHO is WHY SUB ROSA:
1) Merck has developed over the yearS an interest in NWBO re MRK's EVP in R&D Roger Perlmutter shaking hands with CEO Linda Powers at 2019 ASCO (visually verified fortunately by both AlphaPuppy and Photonic5 )and likely explains why
2)former MRK Keytruda Dr. Kevin Duffy is NOW onboard @ NWBO IMHO
The trial will be conducted as an investigator-initiated trial led by the University of Mainz, thereby substantially reducing the costs involved. NW Bio will provide the DCVax-L products and MSD Sharp & Dohme GmbH will provide the Pembrolizumab. (MSD Sharp & Dohme is the operating name used by U.S.-based Merck & Co., Inc. outside the U.S. and Canada.) All of the parties contributed to and approved the novel trial design. (took two years to negotiate)
This trial will combine a broad spectrum personalized vaccine (DCVax®-L) with a highly targeted checkpoint inhibitor drug (Pembrolizumab). In contrast, most combination trials to date have combined two specifically targeted agents, with no broad spectrum agent included.
Immunotherapy for Colorectal Cancer Immunotherapy
Immunotherapy by Cancer Type
How is Immunotherapy Changing the Outlook for Patients with Colorectal Cancer?
Reviewed By: Dirk Jäger, M.D.
Colorectal cancer, referring to both colon cancer and rectal cancer, begins in the lining of the colon or rectum and has the ability to spread to other organ systems and lymph nodes. Over 95% of colorectal cancers are adenocarcinomas, a type of tumor that originates in the mucus-producing glands of the colon or rectum. Recently, the role of Lynch syndrome—an inheritable genetic disorder—in the development of colorectal has come to be recognized. It’s estimated that Lynch syndrome results in about 5,000 new cases of colorectal cancer year in the United States.
Colorectal cancer is the third most common cancer type in the U.S. and the second most deadly. Globally, there are approximately 1.8 million cases of colorectal cancer diagnosed each year, along with over 900,000 deaths caused by the disease. In 2018, there were an estimated 150,000 new cases of colorectal cancer that were diagnosed and 52,000 colorectal cancer-related deaths in the United States alone.
Though overall death and incidence rates among both men and women have declined over the past two decades—largely due to screening tests that detect pre- and early stage disease—underuse of these screening tests means that only 40% of colorectal cancers are diagnosed as early stage, when the survival rate is highly favorable at 90%. As such, new treatments for colorectal cancer are urgently needed.
Colorectal Cancer Treatment Options
Traditional treatments for colorectal cancer include chemotherapy, radiation, and surgery. Though currently the most common treatment for colorectal cancer is surgical, there are several FDA-approved immunotherapy options.
Targeted Antibodies
Bevacizumab (Avastin®): a monoclonal antibody that targets the VEGF/VEGFR pathway and inhibits tumor blood vessel growth; approved for subsets of patients with advanced colorectal cancer, including as a first-line therapy
Cetuximab (Erbitux®): a monoclonal antibody that targets the EGFR pathway; approved for subsets of patients with advanced, EGFR-positive colorectal cancer, including as a first-line therapy
Panitumumab (Vectibix®): a monoclonal antibody that targets the EGFR pathway; approved for subsets of patients with advanced, EGFR-positive colorectal cancer
Ramucirumab (Cyramza®): a monoclonal antibody that targets the VEGF/VEGFR2 pathway and inhibits tumor blood vessel growth; approved for subsets of patients with advanced colorectal cancer, including as a first-line therapy
Checkpoint Inhibitors
Nivolumab (Opdivo®): a checkpoint inhibitor that targets the PD-1/PD-L1 pathway; approved for subsets of patients with advanced, MSI-high colorectal cancer
Pembrolizumab (Keytruda®): a checkpoint inhibitor that targets the PD-1/PD-L1 pathway; approved for subsets of patients with advanced, MSI-high colorectal cancer
Many immunotherapies that show promise in addressing other types of cancer are in clinical testing for colorectal cancer.
CRI's Impact on Colorectal Cancer
The Cancer Research Institute has a long history of supporting scientific research for the advancement of colorectal cancer treatment, seeing many major breakthroughs that have made immunotherapy a promising approach for this disease.
One landmark study in 1998 by Haruo Ohtani, M.D., provided early evidence that immunotherapy treatments can act as a catalyst or enhancement for ideal immunologic conditions that could extend the lives of colorectal cancer patients.
The recent development of the Immunoscore tool, by Jérôme Galon, Ph.D., a new way to classify tumors, better predicts the rate of relapse and survival in patients with colorectal cancers, providing essential prognostic information that can then improve the confidence of clinical decisions and rational stratification of patient treatment.
Research by Dirk Jäger, M.D., a member of the CRI clinical trials network at the University of Heidelberg in Germany, elucidated how immune parameters correlate with prognosis in colorectal cancer.
In one study, former CRI postdoctoral fellow Eran Elinav, M.D., Ph.D., along with former CRI predoctoral scholar Till Strowig, Ph.D., showed that deficiencies in caspase-1, an enzyme involved in the activation and maturation of inflammatory immune molecules, resulted in enhanced tumor formation in a colitis-associated colorectal cancer model.
Explore CRI’s current funding for colorectal cancer research in our funding directory.
HARD KNOCKS for BRAIN CANCER Again: ONLY NWBO + DFFN left!:
Another project is Northwest Biotherapeutics’ controversial DCvax-L, though this company has been sitting on phase III data for years now, and the cancer vaccine seems unlikely to go anywhere.
Privately held(WRONG: :DFFN) Diffusion, meanwhile, continues to enrol inoperable glioblastoma subjects into its trial of trans sodium crocetinate. The company claims that this can re-oxygenate hypoxic tumour tissues, increasing susceptibility to radiation and chemotherapy. Results are some way off, according to clinical trial database entries.
Sojourner55 re:
Has anyone noticed an increased frequency of attack of vulnerabilities in your computer on IHUB lately, especially when you click on the next post? My antivirus/firewall has been blocking all these attacks.