There is "not one other CDMO" such as Avid Bioservices CDMO
FBI has been investigating with others as to the scope of how many sabotaged events there were all surrounding the IP assets beind PS Targeting and those dozens of collaborations Peregrine Pharmaceuticals had will be key
PS exists in plants, humans and animals
PS flips...externalized on "ALL" stressed cells that many become cancerous that most docs will not find until it is large enough
Blood tests now, liquid biopsies ...taking over early cancer screening and many will find it odd that MANY MANY that worked closely with the IP assets ...( Many at Moffitt ..MD Anderson.. MSK etc etc ) are sought after for which protein pathways change "after" one any IP drug like Bavituximab or any other Betabodies were given...
This is why the phase III was purposely shut down ...and the biomarker companies ( Epiontis and Precision Medicine ..) had some golden info
What are the future 15% royalties worth for ALL PS Targeting and other IP assets worth?
Looks like we have some BODs that have become mute, though mutants they can become
Looks like some investigators in Florida behind Moffitt are putting some puzzle pieces together : )
If Alan List and Thomas Sellers were leaving ....due to corrupt practices with "Thousand Talents" in China ...also after PS Targeting Biomarkers etc...Scott Antonia was there long time ....and could have been in the running for a TOP job there .....though he chose to run North and hide behind Duke
Maybe a new Duke report is in the works and as for Ampersand Capital, they sure are busy bees
Avid Bioservices new business model includes 15% royalties for all PS Targeting / other IP asset affiliated Biomarkers leading to surrogate endpoints for FDA approvals etc and why has not Avid CDMO made it 100% clear on the contract that allowed Oncologie Inc to advance with the IP assets?
Maybe because there have been long, ongoing ...IP asset based investigations and some are treating this like the third rail as no one wants to talk
Thanks for all those sending in demands for info to Avid CDMO because they will soon be in advanced talks for tempting offers and it is 100% clear the IP is being shielded by all those shareholders
Duke must be aware of "Thousands Talents" and China and would they hire Scott Antonia under any condition...would Moffitt go seek more answers from Scott Antonia since he all of a sudden up and left Moffitt ?
How much PS Targeting info leaked via Alan List and Thomas Sellers and others at Moffitt .....List and Sellers were heads of Oncology info and KNEW PS Targeting and fired / resigned aftet many years ....more to come
All best start asking MORE questions and directly to Chris Sprowls because many were at risk for not speaking up and saying not only what IP was transferred illegally but IP held back ..
Remember Scott Antonia, Dmitry Gabrilovich and MANY others involved with direct knowledge of the IP assets and one has to wonder why Scott Antonia left Moffitt before the heat came down ...
Florida state Representative Chris Sprowls (R) is leading a special panel looking into foreign influences on publicly supported research. AP PHOTO/STEVE CANNON
Florida joins U.S. government in probing foreign ties of researchers By Jeffrey Mervis
Jan. 9, 2020 , 4:00 PM
Florida lawmakers have begun an investigation into the foreign ties of researchers at the state’s universities and research institutions. The inquiry, the first of its kind at the state level, dovetails with an ongoing federal probe into whether such affiliations, notably with Chinese entities, pose a risk to the U.S. research enterprise.
The Florida effort is triggered by revelations last month that six scientists at the Moffitt Cancer Center had been dismissed for failing to disclose their participation in China’s Thousand Talents Program. The researchers include the center’s CEO, Alan List, and the head of its research center, Thomas Sellers.
“I’m appalled by the actions of the Moffitt CEO and some of its researchers,” says state Representative Chris Sprowls (R), who is chair of a bipartisan select committee created by Republican House Speaker José Oliva. “The question is, has there also been any theft of intellectual property? Clearly, the intent is there.”
The Moffitt case is the latest instance of scientists being ousted from U.S. biomedical research institutions after being accused of failing to disclose foreign research ties or undermining the integrity of the process by which the National Institutes of Health (NIH) funds research. The MD Anderson Cancer Center cut ties with three scientists in April 2019 as part of a larger investigation, and 1 month later Emory University announced it had fired two neuroscientists. All five were Asian Americans.
“No front door” In the past 18 months, NIH has raised questions about the conduct of nearly 200 NIH-funded scientists at more than 60 institutions it funds. Many of the cases involve researchers who received money from Thousand Talents or another Chinese foreign talent recruitment program and did not report it to their institutions.
A nonprofit privacy entity created by the Florida legislature in 1981, Moffitt is one of 51 NIH comprehensive cancer centers; last year it garnered $36 million in NIH funding. Moffitt did not receive any letters from NIH raising concerns about foreign ties, according to a center spokesperson. Instead, it conducted its own investigation after learning that some scientists had failed to comply with NIH and Moffitt policies.
Moffitt does not prohibit foreign collaborations, according to the spokesperson, “but disclosure is mandatory and the specific arrangements have to comply with Moffitt’s rules and expectations.” Moffitt is reviewing its rules governing such collaborations, the spokesperson adds.
The new special legislative committee “will examine any further improper or illegal activities involving Florida’s research universities, medical research facilities, and individuals associated with such institutions,” Oliva said in announcing its formation on 30 December 2019. Sprowls, who is in line to succeed Oliva as House speaker in 2021, says the panel has carte blanche to request records, hold hearings, and gather evidence of what Oliva called “Chinese meddling in Florida taxpayer-funded research.”
Sprowls says the committee has the authority to examine behavior at any institution that receives state funds, regardless of the type of research it conducts. Its charter runs through November, and its first hearing is scheduled for 21 January. And Sprowls, a 35-year-old Republican who represents a district just north of Tampa, is expected to draw on his experience as a state prosecutor in exploring how research institutions monitor foreign collaborations by faculty members.
“The problem with universities is that there is no front door,” he says. “There are lots of ways that researchers interact with colleagues around the world. And while I think that scientific collaboration is important, the reality is that university research is at risk from interventions by foreign governments. And we know they are already doing it.”
“My concern is making sure that tax dollars benefit the residents of Florida and not some other country,” Sprowls continued. “And at this point, I’m not convinced that simply disclosing those ties is sufficient. Universities have already demonstrated that, left to their own devices, they are not doing enough to protect our investment.”
Increased oversight At least one research administrator at a Florida university thinks campuses around the state are already doing a pretty good job of following the rules, and he isn’t sure what will come of the state probe. “I don’t know if legislators are aware of how much we are already doing to address their concerns,” says Gary Ostrander, who, as vice president for research at Florida State University (FSU), is responsible for making sure that his institution complies with the myriad policies governing federally funded research.
Ostrander, who also leads a group of a dozen research chiefs from Florida universities that meets regularly, predicts that Florida institutions “will be giving [legislators] a lot of information that will impress and surprise them. And once we do, I hope they will see that Florida [institutions] are on top of this.”
Ostrander acknowledges that current FSU guidelines might not convey that sense of vigilance. “We haven’t put out a policy yet,” he says when asked whether FSU allows faculty members to participate in Thousand Talents. “But Thousand Talents has been identified as a recruitment tool that can be used for espionage. And we’ve made it clear that [faculty] should not be doing it.”
FSU received some $36 million last year from NIH, and Ostrander says the university did not receive any letters questioning the behavior of its faculty members. But that doesn’t mean FSU researchers are free to do as they please.
Participants in the Thousand Talents Program are often expected to spend a few months or more at their sponsoring Chinese institution, an arrangement that can make it impossible for them to carry out the research that NIH or another U.S. agency is funding. To avoid such conflicts of commitment, Ostrander says, FSU faculty are not allowed to hold a position at another institution. Maintaining what NIH calls a “shadow laboratory” in China is also a no-no, he says, and anyone who violates those rules is putting their job at risk.
At the University of Florida (UF), which received $190 million from NIH last year and conducts more research than any other university in the state, officials say NIH asked about the conduct of two faculty members with NIH funding. The university investigated “possible failure to disclose outside research support, relevant affiliations, or foreign components,” says Steve Orlando, assistant vice president for communications, and both faculty members have resigned as a result of the investigation.
UF officials have also tightened rules regarding foreign collaborations. The university now strongly discourages faculty participation in any foreign talent recruitment program, Orlando says, although in rare cases it might approve such a relationship. A faculty member who fails to disclose their involvement in such a program is subject to termination, he adds. At the same time, Orlando says, “Our campus remains an open and welcoming place to students, faculty, and staff from around the world.”
Let the Sun shine in Despite holding different perspectives on the scope of the problem, Ostrander and Sprowls agree that transparency is the key to preserving research integrity.
“Although some measure of confidentiality may be necessary, it is my intention to make public as much information as is humanely possible,” Sprowls says about the fruits of his committee’s investigation. A Moffitt spokesperson says the cancer center has already shared its findings with state legislators and is preparing to release a “trove” of documents relating to the investigation.
Ostrander says FSU is also eager to work with Sprowls’s panel. “We have a reputation for being transparent,” he boasts. And he has some advice for faculty members who wonder whether they have crossed the line. “Come by and talk to us,” Ostrander says. “Don’t wait until we hear about it from the Department of Homeland Security or the FBI. Because that could be a career-ender.”
Roger Perlmutter knows the immune system must be primed, and since Sunrise phase III Bavituximab patients ...entered Keytruda trial.... and Avid Bio CDMO receives 15% of royalties and manufacturing rights to the IP assets etc etc and JP Morgan knows Merck is all over PS Targeting with Oncologie Inc
"Also, it became clear that mRNA seemed like a natural way of immunizing patients [who might otherwise not respond to immunotherapy]. Keytruda doesnt prime the immune system; mRNA would prime it."
The key to partnerships comes from Wolchoks confirmation that Bavi â??creates a more immune active environment in which other treatments are able to have greater anti-tumor impact.â? Look how this remark echoes and reinforces comments by Dr. Perlmutter, head of IO research at Merck, in an October ESMO article on Keytruda vs. Opdivo. Dr. Perlmutter explained that higher levels of PD-L1 confer a greater benefit from PD-1 blockers and, â??It turns out PD-L1 expression is just a marker for the presence of an immune response.â? Here is a quote from the article: "So what does PD-L1 expression mean" and why do higher levels confer a greater benefit from PD-1 blockers?
"It turns out PD-L1 expression is just a marker for the presence of an immune response," explained Merck's head of research, Dr. Roger Perlmutter.
"Expression of PD-L1 is increased by immune response factors."
IN ENGLISH: PD-L1 is a signal that the immune system has been trying to fight the cancer. Or, as Perlmutter puts it, "Gee, there's already an immune response going on here."
This is why Wolchoks comment yesterday is so important when he confirmed that Bavi's MOA is to "create a more immune active environment":
DR. JEDD WOLCHOK STATES (11-14-16), Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model. It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact.
The really important part of the MSK poster, the part that will wake up all the BP decision makers, is not the mice survival data, but rather all the detailed work MSK did to confirm that Bavi is indeed triggering an upstream immune response, e.g. increase in CD8 T-cells, shift of macrophage from M2 to M1. MSK summarizes this "creation of a more active immune environment" in the 3rd & 4th bullet points of the Poster Conclusion. This is just what Dr. Perlmutter at Merck said was missing in the 80% of patients that don't respond to PD-1. To quote Perlmutter, Keytruda & Opdivo work better when the clinician can say "Gee, there's already an immune response going on here." There is now strong evidence from the MSK poster and Wolchoks summary comments that Bavi triggers an upstream immune response. This will be a huge boost to the ongoing partnership talks. ... ...
It would be relevant to review this post above in full, because some BP woke up ...enough, that even made John Springs Stafford wake up and risk lots ...
BP partnerships come in many forms to guarantees of CDMO contracts to etc etc .....and would it now, seem very odd that Scott Antonia to Dmitry Gabrilovich to Jason B Fleming to Jessica Frakes to many others all under the radar during Moffitt Cancer Center investigations ...Yes
Merck knows 100% that ones immune system must be primed at the most upstream level, the targeting of Phosphatidylserine is required.
Why did Rolf Brekken make a secret trip to China ....just weeks before Nan Fung Group backed Pivotal Bioventure back 30 day old Oncologie Inc with Eli Lilly backers etc
The handle always shows a smaller decline from high to low; it represents a final shakeout of uncommitted holders, sending those shares into sturdier hands in the market.
Avid Bioservices CDMO
One of the biggest cups and handle
Maybe it is time for Peter Parker with BioInnovation Capital to realize, PS Targeting is Huge and even BergenBio requires PS Targeting
Moffitt finally has many now looking at Scott Antonia to Dmitry Gabrilovich to David Carbone to Hakan Mellstedt to Jessica Frakes to Jason B Fleming to the entire mix ...
Joe Munda is going to be something one day. If you run a Hedge Fund and want to meet a Tremendous Analyst find Joe Munda. He passes my Test https://t.co/cFoJH9ZunM
I don't know where Steve Schwartz went as LinkedIn says he was done at First Analysis Securities ...heck, maybe he had intentions to go public and tell everyone how valuable the IP assets are where Avid Bioservices receives 15% royalties etc and all manufacturing rights etc etc .....and will show up as co-CEO with Rahul at Pelican or a promotion at his ex employer ThermoFisher that has been working with Mark Bamforth
____
Cheynew, did you have a copy of the transcript where Rahul asked some good questions ? re: IP assets of Peregrine and strings were pulled to not let news get out on how valuable the IP assets are .... as Rahul found out
Avid Bioservices now has that unique business model of a CDMO with manufacturing rights to IP assets / related IO drugs
____
Rahul R. Jasuja, PhD
CEO, Pelican Therapeutics
Rahul R. Jasuja is CEO of Pelican Therapeutics, a subsidiary of Heat Biologics. He previously served as Senior Biotechnology Analyst at FBR & Co., as well as Managing Director, Biotechnology Research, at Noble Life Science Partners (NLSP). Prior to NLSP, Dr. Jasuja was Vice President of Corporate Development at Idera Pharmaceuticals, focused on developing Toll-like receptor based immune-modulators. He has also held progressively senior positions within the biotechnology capital markets at Techvest LLC, Rodman & Renshaw and MDB Capital Group.
Dr. Jasuja brings more than 20 years of experience in the biotechnology field, including corporate/business development, technology due-diligence, equity research and academic research. Rahul received his Ph.D. in Immunology from Tufts University School of Medicine in which he explored aspects T-cell activation and the subsequent regulation of adhesion receptors in the immune response. He conducted doctoral and post-doctoral research at Harvard Medical School, in the Department of Hematology & Oncology at Beth Israel Deaconess Medical Center.
Dr. Jasuja obtained his B.Sc. in Microbiology & Biochemistry from the University of Bombay and an M.S. in Microbiology from the University of Montana, Missoula, where he studied the role of bacterial cell wall immune modulators on arachidonic acid metabolism and inflammatory pathways in macrophages.
Looks like some are not happy and trying to force break the handle
I think many will be talking about this for many years to come ...Omeros knows..Wolchok and all KOL know .. Roche knows ...Eli Lilly knows ...Steve Demattos (Xencor ex Peregrine) knows...Ronald Demattos (Eli Lilly ) knows ...they all know they require PS Targeting and how much is 15% of infinity and beyond
Mark Ziebell, wipe off the dust on all those NDAs signed they may no longer give any safety net for any involved
Good luck to all long-term Peregrine Pharmaceuticals shareholders ...many
The handle always shows a smaller decline from high to low; it represents a final shakeout of uncommitted holders, sending those shares into sturdier hands in the market.
When To Buy The Best Growth Stocks: How To Analyze A Stock's Cup With Handle
DAVID SAITO-CHUNG 01:30 PM ET 11/27/2019 The cup with handle is to serious investors in growth stocks what the single is to a baseball fan. It's the starting point for scoring runs and winning the investing game. .. ...
Basic Characteristics Of The Cup With Handle The stock needs to show a 30% uptrend from any price point, but it must be before the base's construction. Or, the stock must show a minimum 20% increase from a prior breakout.
The cup with handle must be at least seven weeks long. If there is no handle, then the cup itself must stretch a minimum six weeks.
The handle alone needs at least five days to form, but it could go on for weeks. Make sure it doesn't exceed the cup portion in time or size of decline. A good cup with handle should truly look like the silhouette of a nicely formed tea cup. The handle always shows a smaller decline from high to low; it represents a final shakeout of uncommitted holders, sending those shares into sturdier hands in the market.
In most cases, the decline from high to low should not exceed 8% to 12%. During bear markets, some good cup with handle bases show a large, double-digit decline within the handle. But again, it should not exceed the drop within the cup.
The handle usually begins with a down day in price. Be aware that the handle itself, which must stretch for a minimum five trading sessions, can morph into a base of its own in certain cases. That's not a problem; it's often a stock's way of offering a buy point that's clearer or lower than that suggested by the larger pattern.
The Handle? It Must Be High Enough The handle should form in the upper part of the entire pattern. If it's too low, it's flawed.
One way to check if that handle is proper: use the simple midpoint test. Add the highest price and lowest price within the handle and divide by 2. That number should be greater than the midpoint of the actual base itself.
In most cases, the decline from high to low should not exceed 8% to 12%. During bear markets, some good cup with handle bases show a large, double-digit decline within the handle. But again, it should not exceed the drop within the cup.
The handle usually begins with a down day in price. Be aware that the handle itself, which must stretch for a minimum five trading sessions, can morph into a base of its own in certain cases. That's not a problem; it's often a stock's way of offering a buy point that's clearer or lower than that suggested by the larger pattern.
The Handle? It Must Be High Enough The handle should form in the upper part of the entire pattern. If it's too low, it's flawed.
One way to check if that handle is proper: use the simple midpoint test. Add the highest price and lowest price within the handle and divide by 2. That number should be greater than the midpoint of the actual base itself.
Let's take the cup with handle fashioned by Baidu (BIDU) (see the chart below) in 2007. In the cup base, the high was 134.10 and the low was 92.80. Add the two prices together and divide by 2 and you get a base midpoint of 113.45. The handle showed a high of 132.80 and a low of 120.25, and its midpoint of 126.53 easily exceeded the cup's midpoint.
The handle should also show a downward slope along at least a portion of its price lows, not an upward one.
An upward-sloping handle is flawed; it represents weak demand as new buyers move into the stock at a trickling pace. During the stock's actual breakout, you want to see a new wave of buyers coming in at a torrid pace, not a trickling one.
Also, a steep, high-volume decline should put you on alert. You don't want to buy a stock that institutional investors couldn't wait to unload at any price.
The cup should form smoothly, without major price declines on the left side. Sharp gains on the right side aren't necessarily good, either. You might think that the opposite of a panic-driven exit would be a good thing. Likely not.
Avoid Deep Bases Try to limit your picks to cups that are no more than 30% or 33% deep, except for those built during a bear market. In that case, an exceptional growth stock can fall 40%, 50% or more and still make a successful breakout.
Still, shallower is better. It shows that the big hands are catching the stock.
Look for volume to dry up along the lows of the base. Volume should be light in the handle, too.
Tighter price action is better. This is true of almost all bases. A loose, choppy base shows the stock needs to go far for price discovery. If institutions are holding on to the stock, it won't fall too far.
The Buy Point This, of course, is where all the above parameters lead if they appear correctly. The buy point from a cup-with-handle base appears at the highest point of the handle, plus 10 cents. In the case of former big winner Baidu, the proper buy point during its May 14, 2007, breakout was 132.90, a dime above the handle's intraday high of 132.80.
Less than six months later, the leading Chinese web search engine rocketed to 428, up 222%.
Volume On The Breakout Even if all other parameters come together, you should avoid stocks that break out below their 10-week moving average.
Also, when the stock is breaking out, you should generally see a rush in turnover. Volume should ideally rise at least 40% above its 50-day average. For small and midcap stocks, expect breakout volume to double or triple.
The daily and weekly charts at both Investors.com and MarketSmith make heavy turnover easy to spot. Simply compare the day or week's volume with the moving average line drawn across the volume bars. An Investors.com chart will also tell you in real time how volume is running in comparison with typical level at that time of the trading session.
For the weekly chart, the moving-average line traces 10 weeks' worth of turnover.
What should you do if volume on breakout day is much lighter than usual? Sometimes volume will pick up in the next few sessions. Light volume in the market in general may also be a factor. Also consider that the breakout may have started later in the day.
O'Neil has often said at past IBD seminars that after a stock breaks out, he wants to see weekly volume rise vs. the prior week. This signifies a sudden shift in demand for shares that could continue to build up.
Are quarterly results coming up? If so, traders often hesitate before the news. But if the stock fails to make much headway in price, the relative strength line is fading, and the market itself is not showing positive action then something may be wrong with the timing of the breakout.
At that point, it makes sense to exit the stock, even if the 7%-8% loss-cutting sell rule has not yet been triggered.
So I wonder what happens...NIH spends $30 Billion a year about...
NIH take a major stake in the game and have "some" control in allowing PS Targeting for all
I am sure some agreement could be made but the damage is done, many already accepted monies to stop their PS Targeting advances ..
Remember Dr Jedd Wolchok saying something like " we are waiting on the go ahead from the company"
Maybe Merck wanted to deal with Oncologie Inc or maybe all shareholders will soon realize this has NEVER been about a pure play CDMO
It was about shifting exosomes to MD Anderson
It was about not disrupting the Big Pharma Mafiacartel of profits
There is one problem though, flipped PS is on EVERY stressed cell and many a biomarker depend on it ...many blood tests will depend on it, that want to measure the type and stage of the cancer...YEARS in advance
Let me guess, John Springs Stafford had no idea...lol
The business model plan at Avid Bioservices now, needs clarification from our CEO Rick Hancock
Avid gets paid 15% royalties milestones manufacturing rights from the IP assets and with ALL KOLs having ties to Moffitt and affiliates ...in conjunction with Alan List and Thomas Sellers with 4 researchers under them fired/ resigned ....there is mounting evidence PS Targeting IP assets were involved
Even Jessica Frakes at Moffitt that wanted one of the NCCN trials and Moffitt ties with MD Anderson that also was part of the investigations
200 investigations
Thousands of emails monitored
Rick Hancock CEO can't just sit back and do nothing / say nothing ....what do they think that an announcement of a big contract to push us over $100M will make anyone forget ..
TGF beta-2 Targeting has flipped PS like Mateon OT101 just like the IP crosses over into Xencor
Maybe Heather Cox lawsuit against Peregrine then fleeing to Xencor with Steve Demattos meant other nefarious acts going on...
The researcher just busted in Boston was heading back to the sister institute of Moffitt...and now, things become more obvious that John Springs Stafford did not want PS Targeting to spoil Merck + Xencor relationships ...
All best continue to make those calls, with Alan List and Thomas Sellers removed, how many more are being paid off ?
Remember the patents from Scott Antonia....sold like a payoff to delay PS Targeting
Moffitt Cancer Center in FL ties to Peregrine Pharmaceuticals KOL Dmitry Gabrilovich / Scott Antonia / Jessica Frakes etc etc etc
_____
MD Anderson and Sun Yat-Sen University Cancer Center
SYSUCC has established collaborative and friendly relationships with many renowned international institutes from around the world.[18]
SYSUCC has been a sister institute with MD Anderson Cancer Center since 2003. The purpose is to create collaborative oncology research projects between MDACC and other sister institutes in the fight against cancer.[19][20][21]
In 2004, SYSUCC set up a joint laboratory with the Karolinska Institutet of Sweden for research in immunotherapy, molecular virology and oncological epidemiology.
SYSUCC signed a Memorandum of Understanding (MoU) with the UK’s University of Warwick in 2015, creating a partnership in cancer diagnosis, care and research. SYSUCC and the University of Warwick are exploring opportunities in regards to digital pathology, nursing, and anti-cancer drug research.[22][23]
In 2017, SYSUCC and Fred Hutchinson Cancer Research Center signed a broad five-year Memorandum of Understanding to carryout research on cancer diagnosis and treatment.[24][25]
Dr. Martin on Subcutaneous Administration of Daratumumab in Multiple Myeloma
Thomas G. Martin, MD Published: Thursday, Jan 02, 2020
Thomas G. Martin, MD, clinical professor of medicine, Adult Leukemia and Bone Marrow Transplantation Program, associate director, Myeloma Program, University of California, San Francisco, co-leader, Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center, discusses the impact of subcutaneous administration of daratumumab (Darzalex) on patients with early relapse multiple myeloma.
The phase III COLUMBA trial demonstrated that subcutaneous daratumumab has quicker administration than intravenous daratumumab in patients with early relapse multiple myeloma, explains Martin. The subcutaneous administration of daratumumab takes about 5 minutes. Meanwhile, intravenous administration of daratumumab takes 7 to 8 hours for the first dose and about 4 hours for each subsequent dose, according to Martin. If an institution uses rapid daratumumab infusion, administration takes around 90 minutes.
When daratumumab is FDA approved for subcutaneous injection, it is going to have more widespread use in the early relapse patient population, concludes Martin.
Westjtter, yes and quick response ...not many are left that remembered OxiGene
Now, if back in 2002 era Peregrine was able to utilize any new scientific findings from the collaboration...there are Biomarkers that are in play that also give Pererine, now Avid Bioservices CDMO that will be key.
February 28, 2002 at 12:00 AM EST Peregrine and OXiGENE Conclude ArcusTherapeutics LLC Joint Venture; Companies Reacquire Full Rights to Respective Vascular Targeting Technologies TUSTIN, Calif., Feb 28, 2002 (BW HealthWire) -- OXiGENE Inc. (Nasdaq:OXGN)(SSE:OXGN) and Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM) today announced an agreement to conclude their Arcus Therapeutics, LLC joint venture (Arcus). Under the terms of the agreement, Peregrine will pay OXiGENE $2,000,000 and will reacquire full rights and interest to the vascular targeting platform it contributed to the joint venture, as well as any new discoveries to its contributed technology.
OXiGENE will reacquire full rights and interest to its vascular targeting technology including any new discoveries based on its contribution. The joint venture will be concluded after all technology has been distributed to its respective owners. ... ...
Seems like so much more is going on also...that JP Morgan types don't want some to know ....though some new IIS will find out that buying CDMO in $7 range is true breadcrumbs ...so well worth the investment
I also noticed the ties to Moffitt ...and there are other places as well, that know the true value of the IP assets have yet to even be realized
I would strongly recommend that all read R66 posts from last week and forward any complaints to DOJ, because sometimes one may find out that some even in other Authorities "may" not have it in their interest to pursue open cases ...though with Moffitt new of Alan List and Thomas Sellers gone from Moffitt, I do believe PS Targeting and all other IP assets / Biomarkers will be known to others soon
April 14, 2015 at 8:00 AM EDT TUSTIN, Calif., April 14, 2015 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP) today announced that two preclinical abstracts and one clinical translation abstract are scheduled for poster presentations at the 106th Annual Meeting of the American Association for Cancer Research (AACR), to be held April 18-22, 2015 in Philadelphia, Pennsylvania. Data to be presented include studies investigating the therapeutic potential of Peregrine's phosphatidylserine (PS)-targeting antibodies when administered in combination treatment regimens with approved and developmental cancer immunotherapies and translation data in patients with lung cancer. Peregrine's lead PS-targeting antibody, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications.
Abstract details:
Abstract Number: 274
Presentation Title: Bavituximab modulates tumor microenvironment and activates CD8+ tumor infiltrating lymphocytes in a patient-derived 3D ex vivo system of lung cancer Presentation Time: Sunday, April 19, 2015, 1:00 PM - 5:00 PM Eastern Daylight Time Location: Section 13 Poster Board Number: 2 Author Block: Soner Altiok1, Melanie Mediavilla-Valera2, Jenny Kreahling2, David Noyes2, Tiffany N. Razabdouski2, Nikoletta L. Kallinteris3, Joseph Shan3, Scott Antonia2. 1Nilogen Oncosystems, Tampa, FL; 2Moffitt Cancer Center, Tampa, FL; 3Peregrine Pharmaceuticals, Inc, Tustin, CA
Check post #'s 319124 & 319120 for a refresher on my personal interactions with government investigative officials...especially on who was mentioned as being the subject of a FDA OCI referral...imao...r
Just an FYI I noticed it was 319124 and 319130...though, many posts in that span were relevant.
Thanks for the refresher !
Steve King now with Mateon and interesting..… TrustpointR / blockchain etc in progress
I stated things would get better for CDMO once new management was in place and they shifted..
The only thing that matters would be the shifting of protein pathways, in order to restore an optimal immune response and those PS Targeting based Biomarkers are worth Billions ...
The only thing new management seems to be good at is having their Ampersand Capital backed bag holders use some of the knowledge and create new CDMOs for business growth...sort of a pay day, where they hope some Avid CDMO shareholders accept breadcrumbs
I see there are still lots of undisclosed happenings going on ....where researchers stealing data, vials, research ..Biomarkers etc and more to come that will prove the old BOD did not stand a chance with corruption of some
Amazing how many Alan List and Thomas Sellers types are out there that accept monies to not disclose how valuable PS Targeting truly is ...
CP, have you thought much about secret book discovered with Jeanette Bleecker, since these times ....most are well aware that NIH and FBI been working together and how much of the PS Targeting research was sold to China or other foreign powers ?
The IP asset deal, amazingly completed in record time was done for a reason that has not been told to Avid Bioservices CDMO shareholders ....and why?
The PS Targeting sabotages along the way ...means that the Targeting of flipped PS is so important to cancer research and the business model at hand for Avid CDMO includes all the manufacturing rights and would include ANY drug out there that requires the patents
There have been others investigated for stealing PS Targeting data and I get the sense that the BODs at Avid Bioservices will have to talk about it, to correct the valuation of CDMO....before any future sale is even discussed.
Jeanette Bleecker's Secret Record keeping on PPHM's sabotaged 2nd ln NSCLC clinical trial.
JB has given her testimony before the court several weeks ago now. One thing that keeps filling my mind is HOW was it found out that JB kept secret records. The only thing we know about that is that she kept them because it is explicitly mentioned in one of the PACER court filings.
And yesterday, while having a drink with a good friend who is also invested in PPHM, we talked about that and he brought up a possibility I didn't evaluate yet.
For starters I keep thinking that PPHM salvaged the Bavituximab 2nd ln NSCLC with the help of the secret records of JB. They recalled tons of vials and must have known what exactly they were looking for and must have been sure they could salvage the trial. The bankers had just recalled the loan due to the sabotage and PPHM had a hard time raising the needed cash for operations and salvaging by using the ATM. So they will have considered the cost of every action before engaging in it.
But to use the secret records they needed to HAVE these secret records. In the past I have been SPECULATING about their origins.
1) Did JB crack in February after the dead of her father and confessed out of some kind of guilt (maybe first to Angela and then to Finken) because she for sure realized that people not getting their due Bavi would die faster and so she provided the records at that time (that would imply that CSM knew about the sabotage at THAT time but did NOT before that time and thus Angela/Finken/etc would not have been involved in the initiative of the sabotage, just helping to cover it up).
2) Did she produce the records when the sabotage was discovered during an investigation (eg: FDA) or internal CSM/PPHM after the sabotage was discovered?
3) Were the records FOUND because she was caught in the act? In her office desk for instance.
4) Were the records found during a house search at JB's as part of a gov investigations? PPHM IR confirmed there was an external party investigating (and what happened to that investigation?). In that case why did she keep these records at home? Was it a COPY? Did someone else get a copy?
5) Did the records come up during a deal negotiations. She says I have the records that can save the PPHM trial in exchange for ...? And if she was willing to do that then she actually confessed and may have told who was behind it. Which brings us to point 6 of yesterday evening.
6) Did a COPY of those records show up due to an investigation and a search at the premisses of the party that JB named to be behind the sabotage? That would be a more expected place to find the records then at JB's place because that would be the party that has USE for those records.
These records and how PPHM came to know of there existence and when they came to know it is a major indicator in this sabotage story. I will again emphasize as I did in the past that there is NO WAY we know about these record when JB would not want anyone to know about it. If she has the intelligence to PREMEDITATE a clinical trial sabotage, prepare soft glue labels that can be changed without a trace, knows how to pass that by CSM's Quality Control who knows the FDA doesn't authorize these labels, if she thinks about keeping records and she managed to do that in a continuous and consistent way in order to temper with 25% of the doses in the control arm and 25% of the doses in the Bavi 1mg/Kg arm, then rest assured she can keep the secret records SECRET.
Yet we know about them! So the only way that we can know about them without JB working with the system is that they were discovered.
besides blocking just PS binding to its receptors on immune cells, there is an FC- FC gamma -based effector function leading to ADCC and so on and so forth - an immune effector function that other checkpoint inhibitors do not have blocking PD-1 or blocking CTLA-4. So, you’ve got a component here that is beyond other checkpoint inhibitors, that brings in an effector function that others do not have. Looking at that aspect or looking at some of the translational data, do you think that beyond the PD-1, PD-L1 non-immunogenic tumors, there is a possibility that PS blockade will have far more effect potentially driving [ph??] antigen presentation. Any comments on that?” ..
Rahul was with Noble Life Science Partners...and that question directed towards Peregrine Pharmaceuticals was an errand opener for some ...
To Infinity and Beyond is where Avid Bioservices CDMO will be going ....remember, Ampersand did not just get involved with just a pure play CDMO...as some like to portray
Interesting where Rahul ended up....actually, more interesting where ALL INVOLVED ended up ..signing dozens of NDAs non disclosure agreements
Alex Azar...how much in the coffers just to have DHHS do a little investment or maybe Merck would not like such an idea?
Some things take time, and time is all I had ....it has always been about the IP assets
Once more info goes public ...many more IIS will conclude it was by NO ACCIDENT that John Springs Stafford showed up
It was by NO ACCIDENT that Ampersand Capital plays such a role to have their crew forming multiple CDMOs and PS Targeting based insights into Biomarkers ...
Look at all the CDMOs etc ...some are born fresh with nothing
...yet, Ampersand just had to have those 15% royalties based upon IP assets manufacturing etc etc
The business plan of Avid CDMO Avid Bioservices includes FDA approvals based upon IP assets / Biomarkers / surrogate endpoints ...etc etc
I doubt JP Morgan will be blinded ... or they are even more concerned about their other PS Targeting investments
Since Big Pharma missed the boat on the Targeting of flipped PS ...that has that "immune effector function" and NIH / FBI missed the boat on IP sabotage re: cancer cures...(FBI may have more news soon though proving they didn't miss the boat...just too many Merckly boats roaming about..)
It is 100% possible that many IIS have missed the boat on the true value of the IP assets once held by Peregrine Pharmaceuticals and now part of the business model of Avid Bioservices CDMO
Interesting, I remember "immune effector function " somewhere along the way...that just may reward every CDMO investors in ways rarely seen
... The program managers were looking for exciting new scientific results, Lauer says. But they also found troubling discrepancies between the affiliations and funding that a grantee had reported to NIH and what they wrote in their papers.
“It’s fascinating,” Lauer says. The reporting discrepancy “had been going on for a number of years, apparently, but it took a long time before we noticed it. That’s when we decided there was something going on.”
Initial resistance NIH’s first step was to notify all grantee institutions that it was launching an investigation. That August 2018 letter, from NIH Director Francis Collins, was followed by inquiries from Lauer about specific researchers.
Many universities pushed back, he says, telling him the agency’s suspicions were misplaced. “What we heard was that there’s nothing going on,” Lauer says. A typical response from a senior university official went like this, according to Lauer: “The faculty member says he’s never been to China, he doesn’t receive any support from the government, and he has no affiliation with any Chinese university. They told us we’re just blowing smoke.”
But Lauer says most university officials changed their tune after NIH showed them evidence that included grant numbers from foreign funders and employment contracts with foreign institutions. “So then what happens is that the university digs a bit deeper and finds that, yes, there is a lot going on,” he says. ... ...
AVID new website yet no mention that royalties milestones etc from the IP assets ? Did they mention all the ties to Federal Investigations for which the IP assets was central part as PS Targeting etc is at the heart of most all cancer research ...and those puzzle pieces are all going to resurface
Avid Bioservices CDMO, a fast ...very soon to be announced $100M+ revenue due to non disclosed Big Pharma contract news that will make $8 look like breadcrumbs ....had MORE to offer due to the IP assets than most anyone is aware of
From 2012 the NSCLC sabotage at CSM in Fargo ND with Jeanette Bleecker with CEO Gerald Finken to that prior 12 week HepC trial that results "after the 12 weeks" were HIDDEN to much more ....
Once all this sabotage comes forward and MATCHED with market trading fraud right up to John Springs Stafford forcing the breakup of Peregrine Pharmaceuticals
Is it is a coincidence that CEO Steve King seen how the IP assets were sabotaged on multiple levels and now, Steve King plays a major role incorporating blockchain Trustpoint etc etc where video must be used to secure the process of tracking the entire operation and knowing all involved
Avid Bioservices could likely have just been part of Federal Investigations placing the IP assets to Oncologie Inc ...but we shall see soon
The bottom line is what happened to Joel McComb ...what happened to Roger Lias ...what happened to Steve King ....what happened to the late Dr Phil Thorpe that just passes away during the midst of all the controversy? No way
Why would Ampersand Capital not want to fight for the IP assets ...because PS Targeting is required for ANY chance at all in Immunotherapy because Phosphatidylserine exist on every damn stressed cell that leads to many a disease to cancer
Alex Azar knows PS Targeting and he sits close to Eli Lilly where CEO Laura Benjamin from Oncologie Inc was picked ....so why still, all the silence?
Moffitt ties Dmitry Gabrilovich to Soner Altiok CSO of Nilogen to Jenny Kreahlinh to David Noyes to Scott Antonia to....the list goes on and on and all ties to PS Targeting
$8 pps ? Breadcrumbs breadcrumbs breadcrumbs ....no one has heard nothing and below gives a glimpse into the massive fraud of many and all looking for those cherished Biomarkers that were only available AFTER PS Targeting
...just ask the Bavituximab patients in phase III Sunrise that DHHS Alex Azar must know well ...
April 14, 2015 at 8:00 AM EDT TUSTIN, Calif., April 14, 2015 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP) today announced that two preclinical abstracts and one clinical translation abstract are scheduled for poster presentations at the 106th Annual Meeting of the American Association for Cancer Research (AACR), to be held April 18-22, 2015 in Philadelphia, Pennsylvania. Data to be presented include studies investigating the therapeutic potential of Peregrine's phosphatidylserine (PS)-targeting antibodies when administered in combination treatment regimens with approved and developmental cancer immunotherapies and translation data in patients with lung cancer. Peregrine's lead PS-targeting antibody, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications.
Abstract details:
Abstract Number: 274
Presentation Title: Bavituximab modulates tumor microenvironment and activates CD8+ tumor infiltrating lymphocytes in a patient-derived 3D ex vivo system of lung cancer Presentation Time: Sunday, April 19, 2015, 1:00 PM - 5:00 PM Eastern Daylight Time Location: Section 13 Poster Board Number: 2
Author Block:
Soner Altiok1, Melanie Mediavilla-Valera2, Jenny Kreahling2, David Noyes2, Tiffany N. Razabdouski2, Nikoletta L. Kallinteris3, Joseph Shan3, Scott Antonia2.
1Nilogen Oncosystems, Tampa, FL; 2Moffitt Cancer Center, Tampa, FL; 3Peregrine Pharmaceuticals, Inc, Tustin, CA
________
Michael Lauer leads the National Institutes of Health’s extramural research program. NATIONAL INSTITUTES OF HEALTH NIH probe of foreign ties has led to undisclosed firings—and refunds from institutions
By Jeffrey MervisJun. 26, 2019 , 5:10 PM
An aggressive effort by the National Institutes of Health (NIH) to enforce rules requiring its grantees to report foreign ties is still gathering steam. But it has already had a major impact on the U.S. biomedical research community. A senior NIH official tells ScienceInsider that universities have fired more scientists—and refunded more grant money—as a result of the effort than has been publicly known.
Since August 2018, Bethesda, Maryland–based NIH has sent roughly 180 letters to more than 60 U.S. institutions about individual scientists it believes have broken NIH rules requiring full disclosure of all sources of research funding. To date, the investigation has led to the well-publicized dismissals of five researchers, all Asian Americans, at MD Anderson Cancer Center in Houston, Texas, and Emory University in Atlanta.
But other major U.S. research universities have also fired faculty in cases that have remained confidential, according to Michael Lauer, head of NIH’s extramural research program. And some have repaid NIH “hundreds of thousands of dollars” in grants as a result of rule violations, he says. “I can understand why [the universities] aren’t talking about it,” Lauer says. “No organization wants to discuss personnel actions in a public forum.”
Lauer suspects some of the cases NIH has uncovered may result in the U.S. government banning certain scientists from receiving federal funds, a process called debarment. NIH has referred at least 18 cases to its parent agency, the Department of Health and Human Services (HHS), for further investigation. “We are still reasonably early on in the process,” Lauer says, “and for a number of cases we don’t know where we’ll end up.”
He also thinks other federal agencies that fund academic research may soon copy NIH’s aggressive approach. “I wouldn’t be surprised if other agencies follow our lead and start doing similar things,” he says.
Connecting the dots This week, Lauer sat down with ScienceInsider at his office on the NIH campus to talk about how NIH became concerned about foreign influence and what it is doing to defend the process used to spend more than $20 billion annually on outside research projects.
He says the agency’s concerns were initially sparked by reports that scientists were violating the confidentiality of NIH’s peer-review process, in which thousands of volunteer reviewers rate tens of thousands of grant proposals every year. In mid-2016, he says, NIH received a report from the HHS Office of Inspector General that a Federal Bureau of Investigation (FBI) probe had uncovered an MD Anderson researcher sharing proposals he had been asked to review with several other people.
That’s a clear violation of NIH rules intended to ensure the confidentiality of every grant proposal, Lauer says. But few such breaches ever trigger an FBI investigation. “There are people who will download an application and share it with a postdoc or a buddy down the hall and ask a question,” he says. “People are not supposed to do that, but maybe that’s not a hanging offense.”
But this was different. “Grant applications were being sent to multiple people at other institutions” in other nations, Lauer says about the case. “It was quite scary. Initially, we thought it was [the work of] a few rogue scientists, very unfortunate, but probably nothing more than that.”
It turned out, however, that such breaches were just one aspect of what Lauer regards as a much larger assault on the integrity of NIH-funded research. Over the next 2 years, he says, NIH grant managers would find numerous examples of NIH-funded scientists at U.S. universities who were publishing papers that listed a foreign institution—often in China—as their primary affiliation and cited foreign funding sources in the fine print. But the scientists hadn’t reported those affiliations and grants to their institutions or to NIH, as required.
The discovery was serendipitous, Lauer explains, and grew out of the agency’s routine monitoring of progress reports filed by grantees. “We have about 1300 people here, fully trained scientists, who oversee our [extramural] scientific programs,” Lauer says. “They are assigned a set of grants. And each year they look at progress reports to make sure things are OK. And one question we ask is, ‘What have you published?’”
The program managers were looking for exciting new scientific results, Lauer says. But they also found troubling discrepancies between the affiliations and funding that a grantee had reported to NIH and what they wrote in their papers.
“It’s fascinating,” Lauer says. The reporting discrepancy “had been going on for a number of years, apparently, but it took a long time before we noticed it. That’s when we decided there was something going on.”
Initial resistance NIH’s first step was to notify all grantee institutions that it was launching an investigation. That August 2018 letter, from NIH Director Francis Collins, was followed by inquiries from Lauer about specific researchers.
Many universities pushed back, he says, telling him the agency’s suspicions were misplaced. “What we heard was that there’s nothing going on,” Lauer says. A typical response from a senior university official went like this, according to Lauer: “The faculty member says he’s never been to China, he doesn’t receive any support from the government, and he has no affiliation with any Chinese university. They told us we’re just blowing smoke.”
But Lauer says most university officials changed their tune after NIH showed them evidence that included grant numbers from foreign funders and employment contracts with foreign institutions. “So then what happens is that the university digs a bit deeper and finds that, yes, there is a lot going on,” he says.
University officials insisted it was all news to them, Lauer adds. “Some vice presidents for research and deans have told us that they were surprised, shocked, and horrified when they learned about [these arrangements],” Lauer says. “They said they had no idea some of their employees were spending 4, 6, 8 months away from their institution.”
“We found one person with a $5 million startup package from a Chinese university that wasn’t disclosed to anybody, not to his American university, and not to us,” Lauer asserts. “This is not subtle. It’s not an, ‘Oops, I forgot to list it on a form.’ We’re talking about really, really egregious stuff.”
Those absent without leave scientists were not just stiffing their home institutions, Lauer points out. They were also fleecing NIH and, by extension, U.S. taxpayers. The rip-off became clear, he says, whenever their time commitment to funded research projects exceeded 12 months.
“The American institution thinks it has a 12-month employee who’s working for them,” Lauer explains. “And we give them funding for research that will take 8 months of their time. But they already have 9 months of outside time commitments. So it adds up to 17 months. And that’s not possible.”
Uncovering that faulty math has had financial repercussions, Lauer notes. “Several universities have actually refunded us money for salaries paid during times when, as best they could tell, the faculty member wasn’t at the institution and couldn’t have been working on the NIH grant,” he says. Some of the refunds, Lauer says, are for “hundreds of thousands of dollars.” That is money NIH could have spent on other researchers who are playing by the rules, he adds.
What NIH has learned Lauer says he hasn’t done a thorough analysis of the 180 cases in which NIH believes scientists have withheld information about their foreign ties. But a few things stand out.
“Most of the scientists are well-funded, meaning they have multiple NIH grants,” he says. “Most are ethnically Chinese, although some of our more serious cases are not ethnically Chinese.” Lauer says the scientists work at institutions all over the United States: “We have examples from the northeast, the southeast, Texas, obviously, the southwest, and elsewhere.”
No particular field seems to have attracted more than its share of bad actors, according to Lauer. “All the people at MD Anderson work on cancer,” he says. “But we’ve also seen [cases involving scientists in] mental health, cardiology, neurology, basic cell biology, and so on.”
Lauer declined to speculate on why these scientists chose not to disclose their foreign ties. But he said NIH has found several cases where the omissions were selective. “We’ve seen scientists who reported other foreign grants and affiliations, but not the Chinese grants and affiliations,” he says.
Among U.S. lawmakers and the media, some of the concern about foreign influence in U.S. research has focused on the role of the Thousand Talents Program, part of China’s decadelong campaign to build ties with scientists outside of China. The program provides distinguished U.S.-based scientists with generous packages to set up and operate labs at a Chinese research institution or university.
Lauer says some of those Thousand Talents awards come with very specific instructions to the researcher, including what they are expected to study and the number of papers they must publish in top-tier journals. But the provisions about what activities should and should not be disclosed are not uniform.
“We have seen contracts that say all the intellectual property that this scientist generates must stay in China and cannot be reported to their American university,” he says. “You can imagine that U.S. universities are not happy when they see that. U.S. universities expect to reap the benefits of research done at their institution, and they are losing that [opportunity].”
Other contracts lean in the opposite direction, Lauer says. “They say every paper a scientist publishes must cite the Chinese university,” he says. “Some have gone so far as to say their university must be cited first.” Lauer says those scientists are also required to cite the Chinese entity funding their research funding, “for the same reason we require people to cite their NIH grants: We want to make sure we get credit for the research we have funded.”
Guilt by association? Many members of the Asian American community believe that U.S. government agencies have been targeting Asian-born scientists simply for their participation in Thousand Talents and similar Chinese foreign recruitment programs. Lauer says NIH has no problem with U.S. scientists who participate in Thousand Talents so long as they disclose that relationship fully in their grant applications and research progress reports.
“Thousand Talents is not a threat [to the United States],” he says. “It’s not the specific conduct we are focusing on, it’s the failure to disclose it.”
To make his point, Lauer offers an alternative scenario of what he considers to be acceptable behavior. “A U.S. scientist goes to their boss and says, ‘I would like to work in China for 3 months a year, and I managed to secure a part-time employment arrangement. I’ll tell you what I’m working on, and how intellectual property will be handled, and how much they will pay me.’ And then they report all of that in their biosketch.”
That should be the norm, he says. But it’s not. “If that is what was happening,” Lauer says, “you and I would not be sitting here today.”
AVID new website yet no mention that royalties milestones etc from the IP assets ? Did they mention all the ties to Federal Investigations for which the IP assets was central part as PS Targeting etc is at the heart of most all cancer research ...and those puzzle pieces are all going to resurface
_____
Moffitt turmoil began with national concern over China, stolen research
Feds say they are just beginning to understand the scope of foreign involvement in U.S.-based research, at Tampa's Moffitt Cancer Center and beyond.
(A worker handles samples in a lab at Moffitt Cancer Center, where officials say concerns over foreign meddling have not affected research. [Courtesy of Moffitt Cancer Center])
By Justine Griffin Published Yesterday A sudden change in leadership at Moffitt Cancer Center shook the Tampa Bay medical community last week and quickly prompted the Legislature to take the unusual step of launching an investigation.
But while the news turned heads in Florida, the turnover at Moffitt is part of a national story line that reaches back to the Obama era and has played out with snowballing urgency ever since. In recent months, federal agencies have become increasingly concerned that Americaâ??s investment in top scientific research is being systematically stolen by foreign actors.
At Moffitt, CEO Dr. Alan List, a vice president and four researchers abruptly resigned in relation to possible exploitation of American-funded research by China. Evidence was found that they were compensated by a Chinese talent recruitment program and failed to disclose it, officials at the Tampa-based center said.
The federal government is still trying to grapple with this and instances like it around the country, said Dr. Michael Lauer, deputy director for extramural research with the National Institutes of Health.
"Research has been compromised," he said, though Moffitt claims its own research was not affected.
"Funding went to projects it never should have. Meanwhile, other proposals didn't get the funding they deserved."
The NIH, which gives out $30 billion a year to American scientists and universities for biomedical research, has opened 180 formal inquiries related to instances of foreign meddling in grant research and funding. In some cases, researchers shared peer-reviewed proposals with the Chinese government, and that research was copied verbatim in Chinese laboratories. Other instances include American researchers being paid by both the NIH and the Chinese government for the same work.
"Many of the universities had no clue this was happening on their campuses," Lauer said. "The scientists they employed never told them about any ties to China, or that they were also employed there."
And the interest in American research doesn't stop with medical topics like cancer. It extends to a variety of industries, from energy and the environment to technology, Lauer said.
A team from Moffitt Cancer Center recently met with federal officials to discuss its investigation into how foreign actors might be involved in its research. [COURTESY OF MOFFITT CANCER CENTER] The NIH is working with the FBI to continue to identify cases of intellectual property theft, he said. But Congress also has taken a leading role in trying to understand how this is happening and how to stop it.
The federal government has commissioned studies to get to the bottom of the issue, but so far it's been difficult to discern just when the foreign involvement began and how deep it goes. The scale and scope was hard to define even in a study released earlier this month by JASON, an independent group of scientists who advise the U.S. government.
In November, the Committee on Homeland Security and Governmental Affairs in the U.S. Senate released a report titled, â??Threats to the U.S. Research Enterprise: China's Talent Recruitment Plans," which detailed how $150 billion in American grant funding through organizations like the National Science Foundation, the NIH and the Department of Energy's National Labs is at risk.
"China unfairly uses the American research and expertise it obtains for its own economic and military gain," the report reads. "Based on this investigation, the subcommittee finds that the federal government has failed to stop China from acquiring knowledge and intellectual property from U.S. taxpayer-funded researchers and scientists. Nor do federal agencies have a comprehensive strategy to combat this threat."
A joint committee by the National Science and Technology Council held a summit at the White House last month to discuss the issue, Lauer said. A summary of the meeting describes efforts to be taken by the federal government to ensure better security. Among the ideas: better communication between federal agencies, including making FBI threat briefs more widely available.
In Florida, State Rep. Chris Sprowls, R-Palm Harbor, announced he will lead an investigation into Moffitt and other federally and state-funded academic institutions related to this issue.
A team from Moffitt met recently with Lauer and others in Bethesday, Md., to discuss the centerâ??s investigation so far, according to a letter to lawmakers from H. Lee Moffitt, the centerâ??s namesake and a former House Speaker in Florida. The letter also disclosed that the information has been shared with the Legislature's Office of Program Policy Analysis and Governmental Accountability.
"The Tampa Bay community and Florida taxpayers who send millions to Moffitt every year need more than vague assurances," the former speaker wrote.
In a related development, Moffitt officials confirmed this week that List, who initially said he'd continue to treat his current patients at Moffitt, has since cut all ties with the center.
At the national level, meanwhile, academic associations are developing security guidelines for individual colleges to follow regarding security breaches. The Association of American Universities surveyed members to craft the framework. Penn State University, whose research focuses heavily on energy issues, has been recognized as a national leader in its efforts to be transparent through a new website detailing its compliance policies.
The University of Florida also launched a website outlining the proper disclosure requirements for researchers. Spokesman Steve Orlando said the university developed a new international risk assessment process to screen activities with foreign institutions and developed an electronic system to monitor the disclosures of outside activities and interests.
This year alone in Florida, the NIH awarded 1,456 grants totaling more than $705 million to universities, research centers like Moffitt and other entities. The University of Florida received more than $190 million and the University of South Florida nearly $76 million, according to the NIH website.
While research is generally funded by federal grants, universities benefit from the prestige of publishing the findings and collect royalties on patents and other investments under the 1980 Bayh-Dole Act.
Said Lauer: "Perhaps the most serious loss is that this has enabled China to know what is going on inside American laboratories, and get a head start on everyone else."
10 people who left academic medicine jobs over ties to China
Amid trade wars, the U.S. waged another battle with China this year over intellectual property being developed at major medical centers and research institutions.
In November, The New York Times reported the NIH and FBI were investigating 180 individual cases of alleged theft of biomedical research funded by the U.S. government. The cases primarily involved Chinese or Chinese American researchers, and they spanned 71 major medical centers and research institutions. At least a dozen scientists were fired or resigned at the time of The New York Times report. Read more on the report here.
Becker's covered the stories of 10 researchers and leaders who left academic medical jobs in 2019:
1. Moffitt Cancer Center CEO, center director step down; conflicts of interest cited Tampa, Fla.-based H. Lee Moffitt Cancer Center & Research Institute on Dec. 18 accepted the resignations of President and CEO Alan F. List, MD, and Thomas Sellers, an executive vice president and center director at Moffitt.
2. Former Nationwide Children's Hospital researchers charged with stealing trade secrets A couple who previously worked in medical research labs at Columbus, Ohio-based Nationwide Children's Hospital's Research Institute were accused in September of stealing scientific trade secrets for their own financial gain, according to the Department of Justice.
3. UC San Diego physician resigns amid scrutiny over ties to China Kang Zhang, MD, PhD, an ophthalmologist and the former chief of UC San Diego's Shiley Eye Institute, resigned this summer after a report alleged he did not disclose conflicts of interest in China, according to inewsource, an independent investigative news outlet covering San Diego.
4. 2 Emory scientists out for ties to China Two unnamed faculty researchers left their roles at Atlanta-based Emory University for foreign ties, according to Georgia Health News, a state-based healthcare news publication reported in May.
5. MD Anderson ousts 3 researchers over Chinese data theft concerns In April, MD Anderson Cancer Center in Houston moved to fire three scientists accused of sharing important research findings and data with China, according to The Houston Chronicle.
Maybe Avid Bioservices CDMO has ties to them in someway ...and those 15% net sales royalties are closer than we think
Interesting though, OXiGene became Mateon and Mateon merged with PointR Data Inc with Blockchain / AI driven technology "SharePoint " based upon requirements in CDMO due to sabotage in manufacturing operations and Avid CDMO requires top notch security ( especially if that top 10 BP wants things secure )
Avid CDMO seems to invest in operations such as water filtration ( as told on last cc ) so blockchain AI etc also required
Will Avid CDMO use the same technology ?
Why do we have a CEO in Joseph Carleone that seems like he is not working on big deals ...or is he?
Thanks Cheynew and will be interesting to see if any shorts remain with CDMO before any news Avid Bioservices would want to share
I figured a new CEO would enter before any significant material news to pick up cheap options
What will happen when CDMO announces the name or significance of the top ten Big Pharma contract?
How fast will CDMO rise? Will it rise as fast as flipped PS
Steve King Edgepoint / Mateon "Trust point.." AI driven just may be able to capture that Sonic Boom quickness and as for any shorts holding shares of CDMO ( with No long shares to offset ) will have more flipped PS cells rushing through them I imagine
That may just be their strategy for the day to force more to exit and hope to swing trade back and forth
Heck, I was even hoping to pick up more shares close to $5
Now since the Federal Investigations have reached the depths of Moffitt Cancer Center and ties to PS Targetig IP assets / Biomarkers etc with Scott Antonia and Dmitry Gabrilovich etc etc
It sure seems like some "had" stopped at nothing short of paying big sums of monies to get close to those Biomarkers
How many with PS Targeting knowledge were fired etc from Moffitt?
...but all we got here is a pure play CDMO : )
Looks like many were told to sign NDAs and not speak a word ....those Biomarkers / surrogate endpoints to replace MOS re: early FDA approvals are worth Billions
Blockchain AI manufacturing news bigger than most realize at this point
IBio ties to Ken Dart and now, via Edgepoint - Steve King
King knows 100% about sabotage where PS Targeting IP assets... attempted hijacked
Protein pathways were discovered via the IP assets held by Peregrine Pharmaceuticals ex CEO Steve King and is this a coincidence that we have King back aligned with Ken Dart and iBio? No
This should break out of these levels here very soon!
I agree and interesting plant protein extractions will be expanding
IIS new investors will not be updated till Feb 15 timeframe
Build Biologics Not Barriers
iBio’s unique partnership with Beijing’s CC-Pharming will bring economical, plant-derived rituximab to China
By Karen Langhauser, Chief Content Director
Feb 19, 2019
The current trade conflict between the world's biggest economies — the United States and China — has resulted in both countries imposing billions of dollars’ worth of tariffs on each other’s goods. At the time of writing, U.S. and Chinese officials are meeting in Beijing, attempting to resolve the damaging trade dispute. But the stakes — and the tension — remain high.
As many larger companies in both countries are cautiously stalling business dealings, a small Chinese Biotech and a small U.S. CDMO have decided to put politics aside and work together for the greater good. iBio, a Texas-based CDMO and CC-Pharming, a Beijing-based biologics development company have joined forces to develop biopharma products and manufacturing facilities in the Chinese market, utilizing iBio’s proprietary technology.
Their novel and unconventional union may prove to be a game-changer for the future of biopharma production in China.
THE NEED
iBIO partners with Porton PharmaRobert Erwin, president, iBio and Dr. Kevin Wang, founder of CC-Pharming, execute a Master Joint Development Agreement for a a plant-derived, bio-better rituximab Rituxan (rituximab) was first approved by the U.S. Food and Drug Administration in 1997 and was the first new drug for Non-Hodgkin’s Lymphoma (NHL) in a decade. Since then, its clinical uses have expanded to a range of autoimmune diseases including types of rheumatoid arthritis. The drug came off patent in Europe in 2013, and in the U.S. in 2016, paving the way for biosimilars.
But despite the development and approval of biosimilar versions, treatments are still too expensive for many patients. In China especially, there is a severe lack of access to needed therapies such as rituximab.
“The Chinese market is changing because China’s middle class is growing extremely rapidly — and the demand for these products is going to go up over the next few years. Current capacity cannot adequately serve the rising demands of its population in terms of biologics,” says Robert Erwin, president and COO, iBio Inc.
China’s biologics sector has been held back by regulatory backlogs, capacity restraints and quality issues. While things are changing for the better, bioprocessing capacity remains a challenge.
A DIFFERENT APPROACH Therapeutic antibodies are mainly produced in mammalian host cell lines. For rituximab, Chinese hamster ovary (CHO) cells are used. But in terms of manufacturability and scalability, working with mammalian cells has historically been challenging — and expensive.
In 2017, Dr. Kevin Wang , a Chinese-American biochemist and plant scientist left the U.S. to create CC-Pharming in Beijing. His goal was to apply plant transient expression technology to produce biologic drugs. Wang was enthusiastic about the potential for scientific and manufacturing advances and worked to provide health benefits to the Chinese people — while also offering very attractive business opportunities for a new company. While researching alternatives to CHO, Wang came across iBio and concluded that a collaboration between his new company and iBio accelerate achievement of his goals and be beneficial to both companies.
iBio’s primary research, development and manufacturing system uses vacuum-infiltration to transfect Nicotiana benthamiana plants, grown in a fully contained, hydroponic system. These plants are infiltrated with an agrobacterium vector that “hijacks” the protein-making functions of the plant. The plant leaves replace a traditional bioreactor, becoming a “protein factory” for seven days. The plant biomass is then harvested and the resulting extract is purified through a typical downstream purification as in most biopharma facilities.
Technology transfer and scale-up is vastly simplified because the need to adapt cell lines to the scale of the bioreactor is eliminated in the plant-based process. Simplification equates to cost-savings. The upstream capital required is dramatically less than mammalian cell reactors.
“A main advantage of the iBio manufacturing platform is that you can increase capacity of a fundamental facility at a non-incremental cost. You can double, triple, quadruple facility capacity just by growing more plants — you don’t have to build bioreactors,” says Erwin.
That savings is key for CC-Pharming as they work to introduce a plant-made antibody superior to rituximab in performance and more affordable than rituximab in price to the Chinese market.
COLLABORATION TRUMPS POLITICS Given the present-day tensions between the U.S. and China, it might seem that it’s a less than ideal time to enter into business deals with Chinese companies. In fact, the political climate is such that when iBio and CC-Pharming tried to assemble for a planning session in Texas in October, several members of CC-Pharming were initially denied visas.
But despite obstacles, the biopharma industry is proving to have some level of immunity to political drama. “Government trade barriers should not stop good business deals in the biotech industry,” says Barry Holtz, president, iBio CDMO.
Biotech investments back Holtz’ opinion. According to a recent Financial Times report, China venture capital investors have become one of the most important sources of capital for U.S. biopharma companies.
And much of this investment is driven by the hope that U.S. drug development wins will be introduced to China’s market.
But the iBio and CC-Pharming partnership takes this a step further, by bringing the technology to China, so that market needs can be met locally.
“Empowerment is a great business model,” says Holtz.
The iBio/CC-Pharming partnership is currently in the conceptual design stage with a timeline that iBio calls “aggressive but reasonable.” The goal is an IND approval in two years for a plant-made monoclonal therapeutic antibody version of rituximab and then to add mutually selected products.
iBio, which has similar partnerships with pharma companies in South Africa and Brazil, believes that there is great value to be gained by collaboration.
“A good business deal makes money, not adversaries, and serves an unmet medical need,” concludes Holtz
Inhibitors of Notch signaling can be used not only as direct anti-cancer agents but also as a sensitizer to current therapy.
Why would many Peregrine Pharmaceuticals with IP asset knowledge of biomarkers etc have very close ties to US Medical Institutions that are also being paid by some foreign or outside based groups ...that very possibly; always required PS Targeting and when the evidence is grouped together, with NDAs = Non Dosclosure Agreements signed ....to agreements to stop certain PS Targeting research to MANY involved simply paid off .....even right on down the line to pay off a hedge fund that would shift the IP assets away from Peregrine and over to Oncologie Inc where it has basically been stalled ....
All this means is that cancer patients, cancer support groups should be pissed off that some very well known individuals could be hijacked, paid off in ways by patents being bought to being given nice new promotions etc etc and again, how should Avid Bioservices CDMO shareholders accept all these facts?
You telling me that Peregrine was sabotaged and their #1 goal to bring in TOP medical personnel that seen the innate and adaptive immunity results of PS Targeting...( like Dmitry Gabrilovich or Scott Antonia or Hakan Mellstedt or David Carbone etc ) all just so happened to not talk about the most significant, curing results of PS Targeting to many a cancer patient?
Non Disclosure Agreements should not stand in the way of the truth and maybe once Avid CDMO shareholders voice their opinion that the 15% royalties / milestones etc on net sales and all manufacturing will totally make CDMO into a top ten CDMO ...$500+ pps will be easily reached
Voice those complaints to the FDA for not coming forward with the results of those Bavituximab patients on Sunrise phase III trial that ALLOWED Merck Keytruda to shine and no follow up on prior sabotaged like in Fargo ND CSM where Jeanette Bleecker swapped Bavituximab trial arm drugs where Bavi+ Docetaxel would have been SOC in 2013
Voice those complaints to SEC for manipulating of stock prices ....Ronin Capital knows well how it is done
Voice those complaints to the FBI that have started investigations to over 60 US Medical Institutions that have had paid researchers accept foreign $$$ to steal PS Targeting IP asset knowledge and how many hundreds of emails were monitored ?
Voice those complaints to the DOJ for the FAILURE or possibly, all other Federal Authorities that are possibly given the no-go ahead on Shedding light on all of it ....
Voice those complaints to the BOD at Avid Bioservices that have failed to even mention PS Targeting IP assets that Oncologie Inc should have been advancing ....and maybe, MAYBE we get a new CEO at Avid that will Trump all our expectations, especially those that just think we sit as investors on "just a pure play CDMO"
Maybe my $500 pps, for starters is off....I mean "A Thousand Talents" is not called 500 talents ....I should say $1,000 ...for starters ...ONCE we move from the so called pure play CDMO to much more ...that even a thousand talent voices can't buy.
Peregrine / CDMO KOL Scott Antonia co patent owner Dr James Mule which were both enticed to sell out their patent ....
We are entering a new phase for PS Targeting, where Avid CDMO owns the contract with Oncologie Inc that gives all manufacturing and about 15% net sales on much of the IP assets
Those IP assets must include all PS Targeting patents related ...at Moffitt or any patent that required the knowledge of the Peregrine Pharmaceuticals IP assets ...
All IP asset info leading into 2nd half 2017 re : post # 298016 with Moffitt ties etc ...may now come full circle as general public will be made aware of Moffitt ties to China ( with Oncologie Inc as backed by Pivotal Bioventure China ties etc ) and John Springs Stafford ....
The infamous John Springs Stafford and China ties ? ...
As we await new CEO of Avid CDMO... maybe the IP assets will be shifted into safer hands, because Oncologie Inc has been slow played ...
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Florida House speaker calls for investigation into China-Moffitt ties
Speaker José Oliva taps state Rep. Chris Sprowls to find out whether China benefits from millions spent on medical research at Florida institutions.
Florida House Speaker José Oliva said Thursday that state Rep. Chris Sprowls will investigate ties between China and Tampa’s H. Lee Moffitt Cancer Center & Research Institute following Wednesday’s announcement that the center’s CEO and others have been ousted.
“The news (stories) coming out of Moffitt Cancer Center are of great concern and compel further investigation," Oliva said in a statement. “While Moffitt’s leadership acted swiftly and decisively, a deeper look into this and all of our institutions is in order.”
In an interview Thursday, Sprowls said actions by Moffitt’s CEO, Dr. Alan List, and other center employees had aided infiltration efforts by China and were indefensible. The Palm Harbor Republican, a former prosecutor, said lawmakers should take steps to make sure similar activity isn’t occurring at other academic institutions across the state.
“These research institutions benefit from vast sums of state and federal resources that are funded by American taxpayers,” said Sprowls, who is slated to succeed Oliva as House speaker. “For these researchers to receive monetary gain from the Chinese government and to pilfer our research, that is just alarming news. And I don’t believe it is isolated to Moffitt.”
State Rep. Chris Sprowls greets Florida House Speaker Jose Oliva last year after Oliva was sworn in at the Florida Capitol. On Thursday, Oliva appointed Sprowls to investigate Chinese efforts to benefit from millions spent on medical research at Florida institutions. [SCOTT KEELER | TIMES] Moffitt received more than $36 million this year in grants from the National Institutes of Health, one of the federal agencies investigating the extent to which China is benefiting from U.S.-based medical research.
RELATED: Moffitt Cancer Center shakeup: CEO and others resign over China ties
Moffitt’s board of directors announced Wednesday that List, along with Thomas Sellers, a vice president and director at Moffitt, and four of the cancer center’s researchers resigned under pressure because of a controversy that linked them to possible exploitation of American-funded research by China. List will continue to treat his current patients at Moffitt. He did not respond to multiple phone calls and emails requesting an interview.
Moffitt officials did not divulge whether List and others accepted money from China, but said an internal investigation revealed conflicts of interest and a lack of disclosure of international collaborators. Officials said there is no indication that Moffitt research was compromised or that patient care has been affected.
“We found evidence that people were compensated through the Thousand Talents program and failed to disclose that,” Moffitt officials disclosed Thursday.
The reference was to a program China uses as a tool to recruit talent from Western countries. Sprowls said it’s been “widely reported” that Americans involved in Thousand Talents have received monetary gains.
“I plan to take an active role in looking into the firewalls in place to protect our intellectual property and proprietary information,” Sprowls said. “The Legislature funds these institutions and we need to account for the money we’ve already spent. Taxpayers deserve to know that their money is not subsidizing the Chinese government.”
It was unclear whether Moffitt’s 12-year research and education partnership with the Tianjin Medical University Cancer Institute and Hospital, a 2,400-bed hospital outside of Beijing, is also a source of concern. Moffitt officials are reviewing the arrangement and have alerted the federal government of their preliminary findings.
Thousand Talents was one of hundreds of programs created by the Chinese government to lure back esteemed scientists to improve the quality of the country’s research and innovation, said Ross McKinney, chief scientific officer for the Association of American Medical Colleges.
“The problem wasn’t the recruitment. That happens all the time and there’s nothing wrong with it,” he said. “The problem came when scientists didn’t want to come to China, so instead they’d offer them a part-time job and instructed them not to tell anyone about it.”
Researchers would be paid for their work, sometimes in Chinese currency. Others would steal ideas from peer-reviewed proposals. In some cases, Chinese researchers would copy data and install malware on university campuses, McKinney said.
“These researchers were told to lie,” he said. “And all of a sudden, someone in China is doing the very project you proposed to do. It is a very serious structural effort on the part of the Chinese government.”
Oliva alluded to that activity in his statement Thursday.
“Floridians, and all Americans, should be greatly concerned at both the potential theft of intellectual property and the corruption it implies,” the statement said. "Compromising our public health and research institutions puts all of us at risk. The Florida House will do everything in our power to hold people, and institutions, accountable.”
In an email, NIH officials said Moffitt’s review showed “that several individuals involved in NIH grants, some of whom are members of the Moffitt Cancer Center leadership team, failed to disclose substantial contributions of resources from other organizations, foreign affiliations, and financial conflicts of interest.”
The statement also said NIH will work with Moffitt “to determine the extent of the violations and remediation actions.” The response, it said, could include the removal of more researchers and the return of grant money to the government. The agency also commended Moffitt for “identifying and disclosing these violations to NIH.”
The agency, one of the largest funding sources for medical research in the world, has launched 170 formal inquiries into American academic institutions this year where ties to China were unclear. Researchers were fired at Emory University and the University of Texas MD Anderson Cancer Center. In some cases, the FBI is involved.
“China has pioneered a societal approach to stealing innovation in any way it can from a wide array of businesses, universities and organizations," FBI Director Christopher Wray said in April. "They’re doing it through Chinese intelligence services, through state-owned enterprises, through ostensibly private companies, through graduate students and researchers, through a variety of actors all working on behalf of China.”
Wray added: “At the FBI, we have economic espionage investigations that almost invariably lead back to China in nearly all of our 56 field offices, and they span just about every industry or sector.”
But rooting out who is leaking information has been a challenge, McKinney said. The scale and scope of the problem was even difficult to define in a study released in December by JASON, an independent group of scientists which advise the U.S. government.
“We don’t know how deep it goes. We’re not good at this sort of inspection,” he said.
For decades, American medical and research institutions have forged relationships with foreign collaborators to share information and research strategy, said Jay Wolfson, a professor at the University of South Florida’s College of Public Health and an expert on health care policy.
“For years, some of our best and brightest students have come to study in America from China, South Korea, India and South American countries," he said. "Some stay and join faculty. Others return home and want to maintain those relationships. Collaboration like this improves quality of life and science.”
McKinney reiterated the point, saying the U.S. has a rich history of science being done by immigrants and in collaboration with other countries. “It’s a shame that it could be damaged by the effects this program has had on trust,” he said.
Some scientists fear the U.S. government could go too far and create regulations that would stifle future research collaborations, said William Colglazier, a senior scholar with the Center for Science Diplomacy at the American Association for the Advancement of Science.
“There are two sides of this coin," he said. “It’s in everyone’s interest that we can all benefit from any breakthroughs that happen in science, no matter where they are. The other side is that clearly China has not followed the norms and standards of ethical requirements, and they need to understand that this cannot continue.”
Any investigation by state lawmakers would look into other academic institutions in Florida beyond Moffitt, including the Mayo Clinic in Jacksonville, the University of South Florida and the University of Florida, which also receive NIH grants.
UF Health in Gainesville strengthened its processes and protocols recently due to the NIH inquiries, said spokesman Steve Orlando. That included launching a dedicated website to explain new requirements of researchers.
Earlier in the year, Moffitt officials had pitched a multi-million dollar expansion to its Tampa campus to meet greater patient needs. Sprowls said state funding for the cancer center’s expansion project isn’t off the table, but Moffitt leadership has some questions to answer first.
“It’s a separate issue," Sprowls said. “But they have to account for these unanswered questions.”
North, I have looked at those PS Targeting posters more times than most other info
Very interesting how everyone involved is doing well ....what do you think about Wayne Holman and Ridgeback Biotherapeutics ...on the news of being awarded PS Targeting patents from DHHS Alex Azar ex Eli Lilly ...?
Some third party labs can prove PS Targeting MOA on many drugs and patents ...sounds like we need to know more about that IP asset transfer and any sidenotes part of it
Licensing fees could fetch more Billions that some expect ...as Avid CDMO could be quite the stock to own for quite a while
Dec 13, 2019 was the ex-dividend date that one needed to have CDMOP in order to be eligible for div payout
Ronin buys all the way leading up to Dec 13 so now he is not eligible for the div payout on those shares and that was the only escape route to exit and profit
I would have to review the dividend term rules for exchanging shares to the common because it seems that anyone wanting to exit now...will quickly out CDMOP back to $25-
It seems that Ronin Capital was as lucky as Black Rock when they exited "before" that Monday morning Sept 24 2012 and then got back in with even "more" shares as it was proven CSM sabotaged the trial
I couldn't find one other stock that Black Rock sold out on one quarter ...and bought back with even more shares the following quarter
I wonder what else Black Rock and Ronin Capital have in common...besides Brian Weston algo boxes
Looks like Avid Bioservices CDMO ready for their next leg up ....especially with a new CEO PR ( as one can assume the CEO will get in now before further bigger announcements are made )
Looks like Ronin Capital believes the dividend is not worth it much any more and even hints at the closing of the preferred shares as bigger news looms ahead
PS Targeting is HUG-GE and manufacturing for Halozyme seems like news can come at any moment but I am sure Ronin Capital can have Brian Weston adjust timing of MMs etc to get more CDMO just in time ___
CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma
Company Announcement
CHMP issued positive opinion for DARZALEX® in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
Final decision from European Commission expected in the coming months
Opinion based on data from Phase III CASSIOPEIA study
Copenhagen, Denmark;
December 13, 2019
Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX® (daratumumab) in the European Union. The recommendation is for the use of DARZALEX in in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
"We are very pleased with this positive opinion from the CHMP as, if approved, the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone would be the first DARZALEX containing regimen that would be a potential treatment option for newly diagnosed patients with multiple myeloma in Europe who are eligible for ASCT," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The Type II variation application was submitted to the EMA by Janssen Pharmaceutica NV in March 2019 and was based on the Phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
Why would Lisa Stepp also be consultant there? ...I guess one never knows what the full circumstances are yet....
Block chain is coming though, to a CDMO near and dear to all of us
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Why the Industry Is Moving Toward Blockchain Technology
December 6, 2019
R&D Blockchain
Given that blockchain technology allows the secure creation and sharing of time-stamped records among numerous parties in real time, it isnâ??t surprising that it might be of interest for improving the pharmaceutical supply chain. Pharmaceutical companies arenâ??t stopping there, though. Blockchain technology is being explored for drug discovery, clinical trials and much more.
What Is Blockchain Technology?
Blockchain technology has its origins in the field of cryptocurrency and was originally used to establish Bitcoin, the first viable digital currency. A distributed ledger technology (DLT), blockchain enables proof of ownership and the transfer of ownership from one entity to another without using a bank.1 Today, it is used for many different applications in many industries because it offers a unique combination of features not possible with other digital technologies.
Those features include the creation of permanent, immutable, signed and time-stamped records of ownership of assets of various types, identities, transactions and contractual commitments that can be shared among all members of a business ecosystem in near real time.2 The records are stored on dozens to thousands of computers around the world.
Authorizations can be assigned to specific types of information by specific members. Most importantly, blockchains are â??essentially unhackableâ? for anyone without authorized access. That is because once a record has been added to the â??chain,â? the data cannot be altered or deleted, because new blocks can only be added to the end of the chain.3 In addition to this high level of security, blockchain technology enables supply chain transparency.2
Everyone in the supply chain can access the same data as soon as it is created. The sources of data and records are also more clearly identified and can be readily traced, significantly decreasing the time it takes to identify problems in the supply chain and increasing the ability to manage quality and inventory flows.
Business transactions can also be accelerated when blockchain technology is combined with â??smart contractsâ? and the Internet of Things (IoT).2 For international transactions, the time it takes to transfer ownership of goods can be reduced from 10 days to 10 minutes.
There are many potential uses for blockchain technology in the pharmaceutical industry, including facilitating patient, physician, payer and pharma company access to medical records; prescription sharing, enhancement of the supply chain, tracking and reporting of clinical trial data, provider credentialing, quality-of-care tracking, drug pricing strategy tracking and adverse event tracking and evaluation.3 The primary use for blockchain in the pharma industry, according to KPMG analyst Arun Ghosh, is to serve as a â??ledger of truthâ? for sharing complex information with regulators, pharmacy benefit managers, contract manufacturers, physicians, patients, academic researchers and R&D collaborators, among others.4 In 2018, Accenture estimated that, in the life sciences, blockchain technology could provide a $3 billion opportunity by 2025.5 Focus on Enhancing the Pharmaceutical Supply Chain Given the ability of blockchain technology to enable secure and rapid transactions around the world, much of the efforts in the pharmaceutical industry to leverage its capabilities are focused around improving the supply chain.
One of the biggest benefits of blockchain technology is the ability to create an auditable trail and establish drug provenance across the entire supply chain. A survey conducted by Pistoia Alliance revealed that nearly 70% of pharmaceutical and life science leaders believe blockchain will have the greatest impact in this area.1 With a decentralized blockchain solution, both manufacturers and their clients would be able to independently verify the quality and point of origin of drugs quickly and securely.6
Transparency and security are two other key benefits of blockchain technology for members of the pharmaceutical supply chain. All of the stakeholders involved in the supply chain must be able to share and update data while also being assured the data is timely and accurate.7 With blockchain technology, the entire supply chain can be managed with one piece of software that is shared between authorized stakeholders. In addition to drug manufacturers and their suppliers, payers, providers, pharmacies, and patients can access the data and see when it is updated in near real time.4 With blockchain technology, these issues can be avoided because the entire supply chain can be managed with one piece of software that is shared between authorized stakeholders. In addition to drug manufacturers and their suppliers, payers, providers, pharmacies, and patients can access the data and see when it is updated in near real-time.4
Blockchain technology also has the potential to help prevent diversion, counterfeiting and tampering, because drug products can be tracked from the time they are produced until the time they reach patients. Any attempts to change records will be visible to all parties immediately.4
As importantly, recalls are much simpler.4,6 The product can be readily traced back to the manufacturer and associated with a production batch, allowing identification of other potentially problematic products and where they had been shipped. A Note about Blockchain and Serialization
Blockchain technology will play a pivotal role in the industryâ??s ability to comply with various serialization regulations around the world, including the 2013 U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive 2011/62/EU (FMD). Serialization involves the unique identification of every drug product at the level of individual units, as well as in aggregated packaging units. Information on the product, its manufacture (location, date, batch number, etc.), logistics route, and so on, must be shared with all supply chain partners involved in the delivery of the drug to the patient. The intent is to make it possible to trace products back through the supply chain to their point of origin.
The transparency and security of blockchain technology is ideally suited to enabling serialization, not only because it enables data sharing, but also because the records are unchangeable, which facilitates regulatory auditing.8,9
Yes, even more interesting is HC Wainwright covers other PS Targeting biotechs giving an update on Sept 10, 2019...same day they covered Avid CDMO.
...being "Omeros" that went public that PS Regulates Tumor Immunity etc
Sounds like the IP assets will provide Avid CDMO that $100+ pps
15% on net sales ...and manufacturing ...maybe Avid BOD should have held onto that warehouse storage space (if they did, we would be close to break even : )
R66, what are your thoughts with Avid BOD not mentioning anything related to the IP assets ?
There is more going on than most think..
Ampersand Frank Witney was brought into Ampersand and Perkin Elmer etc for a reason...
Once all the facts come out, including ALL those at Perkin Elmer etc ...and Ultivue ties to AstraZeneca (Definiens) / Merck etc for Biomarkers / imaging based upon PS Targeting ...things will become clear for all
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The Trump administration called this biotech VC firm a suspicious agent of China. It’s run by U.S. citizens By REBECCA ROBBINS @rebeccadrobbins DECEMBER 6, 2018
When the Trump administration accused China of “unfairly” using venture capital to acquire technologies last month, it singled out the firm 6 Dimensions Capital, calling it a suspicious agent of the Chinese government bent on acquiring U.S. biotechnology.
That came as a surprise to 6 Dimensions’ CEO, Leon Chen, who said neither he nor anyone at his firm had ever been contacted by the U.S. trade representative, which ... ....
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Ultivue has Leon Chen an interesting cast off of characters ...including Sean Downing Ex Perkin Elmer where BOD Frank Witney knows well of the true value of IP assets / PS Targeting / Sunrise biomarkers / etc
Some Big Pharma heads are still spinning how to play this ...
Didn't Povotal Bioventure open their doors the same 6 Dimensions Capital ? Seems like there are more puzzle pieces all coming full circle ...
But I will take a $7+ breadcrumb pps ...till the real news is able to go public
Certainly a nice call, yet like Daniel Getts Stealth biotech it was all about trying as hard as possible to allow more IIS to get in cheap and under $10 is breadcrumbs for what is coming
There are many ...many positives but they decided they needed to save some warehouse spacing that cost how much on the balance sheet ? They could have broken it out but decided to take the write off all this past quarter ....
Looks like they didn't want to break even this quarter as it would have opened more (retail) eyes ...though the Israel Englander type IIS know what is coming
Maybe Frank Witney will come to realize that he can't be as greedy as Ampersand may want to be.. even Merck Paul Young and others know ....
As for the ties to Daniel Getts and patents with Cour to his new patents ...what is Catherine Mackey thinking ??
Nothing to see here though....we are told we are just a CDMO : )
Attaching this to CJs post in case one wants to read the entire post...
....and to compare to 4-30-19 numbers... with a comment from Hancock that they reached cash flow positive during that fye
Revs Guidance (FY’20 fye 4-30-20): $64-67M. 4-30-19 Backlog=$46M as of 4-30-19 *Cash: 4-30-19: $32.4M *As of 6-14-19: 56,137,724 shares o/s. ... ... Hancock: "Most importantly, during Q4, the Company achieved positive income, generating cash from development & mfg. operations for the 1st time since the beginning of the transition. ..."
Cash flow positive is cash flow positive and now it is very easy to tell when they manipulate the numbers ...
They already gave the yearly outlook..."before" signing a new contract with a top 10 Big Pharma and they failed to move the guidance up unless they are really ignorant but my guess is not...since some of the same BODs have reached good deals with ThermoFisher on other CDMOs they have in their pockets ...
How many patents exist that infringe upon PS Targeting patents are out there that Avid CDMO or Oncologie do nothing about?...as it becomes increasingly clear that Biomarkers derived out of PS Targeting are worth Billions ...which is crucial why Eli Lilly just went public re: PS Targeting Sept 10 to Nov 19 to just last week that PS Targeting Biomarkers were given the 100% ok to remain hidden to block away from other BPs that have not gained a full understanding of the protein pathway changes DUE to PS Targeting
Well...Avid CDMO has a contract that was never 100% released to public but we do know Avid CDMO picks up all manufacturing and about 15% net sales
Send in the complaints to FDA SEC and one must send to FBI because most times FDA and SEC don't push unless they get pushed ...and to DOJ because FBI needs to be on alert as well ...and DHHS giving patents to Ridgeback Capital affiliate Ridgeback Biotherapeutics (mab114 etc) Wayne Holman (ties Steve Cohen etc)
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As for Bio-Rad that supplies Bavituximab / PS Targeting antibodies ...would it not raise flags to Oncologie Inc or Avid Bioservices BOD and if not....why not?
Bio-Rad (Norman David Schwartz sin of Alice Schwartz ) has many subsidiaries such as RainDance (liquid biopsies ) in Billerica MA / GnuBio in Cambridge MA / MorphoSys US ( with big ties to MorphoSys AG and Merck ) and the list goes on .....
Would it not be a conflict of interest where the Avid CDMO allows the selling of Bavituximab via Bio-Rad to self serving Merckly networks and not one question arises from our BODs at Avid and as for Oncologie Inc ....who knows who they work for as it certainly now should raise major red flags that Merck is their way to advance the IP assets .....
I guess we could always ask Ronald T Aimes at Emergent Biosolutions ( split off into two with Aptevo ) and PS Targeting based patents as Aimes worked for Peregrine etc etc and MidCap Financial on some of their patents as well .....
Maybe we should start demanding answers from Scottish Development International players involved ...
I ___
February 05, 2019 / 10:01 pm, CET
Planegg/Munich, Germany, February 5, 2019
MorphoSys Announces Appointment of David Trexler as President and Member of the Board of Directors of MorphoSys US Inc.
... ... Mr. Trexler has built his career in leadership positions for branded pharmaceuticals in marketing, sales, business development and general management. He joins MorphoSys from EMD Serono, a business of Merck KGaA, Darmstadt, Germany, where he held positions of increasing seniority including most recently positions as Global Brand Lead, Bavencio and Senior Vice President US Oncology Commercial. At EMD Serono, he was responsible for building Merck KGaA's first commercial oncology footprint in the U.S. and for the successful launch of Bavencio (avelumab) for metastatic Merkel cell carcinoma (mMCC).
CJ, Biomarkers are the most important factor at this stage...as without Biomarkers based on PS Targeting...some can not gain fast ...very fast ..FDA approvals
I am only taking a small portion of a post that should be ready slowly...but all should see the Perkin Elmer ties ...actually 3 of them, well more if one includes Frank Witney now...our Ampersand Capital sidekick to Mark Bamforth and Patrick Walsh ...
Things will continue to become I increasingly, interesting around here ..
... #4 6/3/17 ASCO’17 #11603 (Session: Tumor Biology) “Preliminary Correlative Analysis of PD-L1 Expression from the Sunrise Study” http://abstracts.asco.org/199/AbstView_199_190902.html AUTHORS: LEAD: Nikoletta Lea Kallinteris (PPHM) Rachel E. Sanborn (Co-Dir., Thoracic Oncology Pgm, Robert W. Franz Cancer Res. Center, Earle A. Chiles Res. Inst., Providence CC, Portland; Honoraria=AstraZeneca; Consulting=Amgen/Ariad/DNA/PPHM/SeaGen; Funding=BMS/MedImmune/Merck) Leora Horn (Oncologist/Vanderbilt-Ingram CC; Honoraria=Biodesix; Funding=AZN) David E. Gerber (UTSW) Ronald B. Natale (Med.Dir/Lung-Cancer-Pgm/Cedars-Sinai Medical Center; consult/funding=AstraZeneca) Min Tang (PPHM) Sean Downing (Scientist/Molecular Pathology, Foundation Medicine Inc., Cambridge MA) http://www.foundationmedicine.com ; disclosure=PerkinElmer) Amanda Clement (Scientist/PerkinElmer; disclosure=Abbvie) Tobias Guennel (Sen.Dir., Translational Informatics & Biometrics, Precision for Medicine, Frederick MD https://www.precisionmedicinegrp.com/pfm ) Joseph Shan (PPHM, VP/Clin+Reg) SENIOR AUTHOR: Cliff Hoyt (Oncology Fellow/PerkinElmer)
I am sure some will figure it out sooner or later ....but I guess Ampersand can always just make a big splash announcement with Bio Rad ( has a subsidiary MorphoSys US ties to same MorphoSys that lost patent war to JnJ recently for MM ) and maybe Alice Schwartz ( Bio Rad Billionaire that buys Bavituximab ...hmmm) will put everyone in their place and she can just throw a twist into all this for all the greed that continues
Mr Bamforth, you can call Frank Witney now and maybe realize ...investigations are active and one whistleblower is not much to ask for when things are so obvious ...unless again, it was part of some plan... (though then we got John Stafford who just so happened to fell into this to allow things to happen ...kind of in a bind)
A "Rare Site" into how things go down does not happen very often...and so much more but Nantucket is a busy time of year at this time
I can promise that and ex Omeros Clark E Tedford can't even deny the protein pathways that PROVE PS Targeting required
Omeros goes public for very first time making it clear that tareting of Phosphatidylserine is required
Sept 10, 2019 ...goes public PS Targeting
Nov 20, 2019 ...conference presentation
Dec 4, 2019 ...surrogate Biomarkers based on PS Targeting
Furthermore, the discovery that PS itself stimulates an immunosuppressive GPCR namely GPR174 on all lymphocytes represents a significant advancement in our understanding of how PS regulates tumor immunity.
.. ... Relevance of Findings
Omeros findings are also particularly relevant for patients resistant to checkpoint inhibitors, such as anti-PD-1 (e.g., Keytruda and Opdivo) and anti-CTLA-4 (Yervoy), and to emerging cellular therapies such as CAR-T cells and adoptive T-cell therapy. Checkpoint inhibitors are only effective in a minority of patients, and high levels of adenosine-generating molecules have been observed in non-responding patients. Furthermore, overcoming natural immunosuppression in solid tumors represents a major hurdle for cellular therapies. Because PS and adenosine are both products of cell stress and death in solid tumors, it is expected that patients resistant to checkpoint inhibitors or cellular therapies would benefit greatly from the combined inhibition of the GPR174 and adenosine pathways. ... “Our team’s discovery of the GPR174-controlled cancer-immunity pathways and their interrelationships with the adenosine pathway have been methodically elucidated and defined,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Simply put, Omeros has discovered that there are two feet on the cAMP brake pedal restraining immunity against the tumor and, to enable effective tumor-killing activity, both GPR174 and the adenosine pathway must be inhibited. We are optimizing our small-molecule GPR174 inhibitors with the objective of moving orally available therapeutics into the clinic as rapidly as possible. We look forward to providing physicians and patients with a new and broadly applicable option in cancer immunotherapy.”
Omeros is preparing a manuscript for publication detailing its GPR174-related discoveries and data and plans to present these same discoveries and data beginning this year at upcoming oncology international congresses. .... ....
________________
Full article below:
Omeros Discovers New Cancer-Immunity Pathways Controlled by GPR174
OMEROS’ NEW GPR174 IMMUNO-ONCOLOGY DATA PRESENTED AT THE AMERICAN ASSOCIATION FOR CANCER RESEARCH CONFERENCE IN BOSTON
.... .... GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform. ... ____
Dec 4, 2019
All of a sudden ....Omeros has surrogate MOS endpoints and FDA allows to have modified the primary and secondary endpoints ....and all this just after they went public re: PS Targeting
I will say this ....the fog will be cleared soon and does Ampersand Capital truly have Avid Bioservices CDMO shareholders in their best interest ?
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Catherine Mackey may not even have Avid CDMO in her best interest....especially with the latest PS Targeting based patents this past week at Cour Pharmaceuticals...David Getts etc but this will be another post
Golfho, have you given much thought about how "forward guidance" of the negatives were given by Avid BOD
They were so gracious ...actually as if hoping more would sell out ...due to the 2 or 3 week mandatory shutdown of some equipment
Now here we are just days away from when they tell us how we would have done better so I assume they remind everyone of more details of those shutdowns and give the positive guidance forward
Seems strange that the BODs have initiated other CDMOs with deal talks (the same Patrick Walsh and Mark Bamforth ties ) and even some deals with ThermoFisher ...yet here, it is as if some higher powers trying to squeeze out some more shares
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I remember the talks at the ASM reminded shareholders of some info below:...
We are looking at collaborations with our clients, which is increasingly being used in biologics. Clients may participate in a low/no-interest loan. They may pay for their own equipment for us to create their product. If they participate in financing, then they have dedicated capacity. Vendors may give help via discounts and other incentives. We are VERY sensitive to dilution and would not do that unless we had an acquisition that would be a game-changer or had a very significant adding of capacity.
Post 332097 332104
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So no details given yet to us shareholders but Ampersand spending Millions on new ventures and making deals with ThermoFisher ...very strange
Now, a collaboration of PS Targeting...in Omeros....have new Biomarkers "BASED UPON" PS Targeting and they just publicly disclosed Thursday this past week....that the FDA approved ...but they can't disclose the Biomarkers / surrogate endpoints
John Springs Stafford did not come into the picture to break up the IP ...allowing it to be shifted to Oncologie Inc with ex Eli Lilly groupies led by CEO Laura Benjamin ...for no reason at all.
Some could say he did so ....so the new CDMO Avid Bioservices can fast track to stardom (without the drag of R&D etc on IP assets) but the BOD at Avid, for a company that IS CASH FLOW POSITIVE have been nothing short of scared it seems...and the analysts? Hell, the analysts seem to have no clue what it means to initiate or to trigger all protein pathway events. Maybe they can call Stryker and see why they picked up "Mobius Imaging" that at the cellular level...it is astronomical as to what one sees AFTER PS Targeting
Looks like those EXOSOMES have flipped PS and yes, worth Billions if one has the patents on Targeting flipped PS
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Exosomes as nanocarriers for systemic delivery of the Helicobacter pylori virulence factor CagA
Introduction Helicobacter pylori is a gram-negative bacterium that colonises the human stomach. Nearly half of the world population has been estimated to be carriers of H. pylori and infection with H. pylori is associated with the pathogenesis of gastric disorders, such as atrophic gastritis, peptic ulcers and gastric cancer1,2,3. Among reported H. pylori virulence factors, much attention has been focused on CagA, a protein encoded by cytotoxin associated gene A (cagA), because of its strong association with severe gastric lesions, particularly gastric cancer4,5. CagA is a bacterial effector protein that is injected into gastric epithelial cells via the type IV secretion system (T4SS). Inside host epithelial cells, CagA undergoes....
( *** Hold on a minute, it just said "inside host epithelial cells..." but HOW ?? ....let me repost some highlights from the most up to date research that has been known for quite some time by some, and will be in the hands of new IIS now *** ) ..... ....
... ... To further facilitate the delivery of CagA, H. pylori induces the membrane phospholipid phosphatidylserine (PS) found in the inner membrane leaflet of epithelial cells to be exposed on the outer membrane.63
CagA interacts with the exposed PS to initiate its secretion into the host epithelial cell. ... ...
___
... ... CagA, which is also exposed on the bacterial surface via type IV secretion, interacts with the membrane-externalized PS. The CagA-PS interaction triggers the entry of CagA into host epithelial cells, which also requires energy-dependent host cell processes distinct from known endocytic pathways.
A gut microbiome feeling Avid Bioservices CDMO has major talks upcoming, because 3rd parties doing their own investigative MOA studies of assorted drugs out there : ) ...and my oh my ....PS Targeting is everywhere
Hold those shares because some will stop at John Springs Stafford....I mean nothing, to delay the inevitable.
PS Targeting truly will turn Big Pharma upside down ...hell, if you have it you have it....and ALL stressed / inflamed / cancerous diseased cell HAS flipped PS
Mr Hancock can feed us whatever he wants....the more resistance and reaction that takes place ....the easier it is to track
Mr Alex Azar (ex Eli Lilly / now DHHS ) to Joseph Grogan ( ex Amgen / Gilead / US advisor now) to others .... this is like HD TV with slow replay ....all are going to see PS Targeting engaged FIRST
Maybe Stan Fleming can make another billion on this play
___
Molecular anatomy and pathogenic actions of Helicobacter pylori CagA that underpin gastric carcinogenesis
Atsushi Takahashi-Kanemitsu, Christopher T. Knight & Masanori Hatakeyama
Dec 5, 2019
.... ....
Translocation of CagA into host gastric epithelial cells by H. pylori is achieved via a specific interaction between surface adhesins of the bacteria and receptors for the bacterial component on the host cells. In recent studies, carcinoembryonic antigen-related cell adhesion molecules (CEACAMs) have been identified as a set of protein receptors on epithelial cells that are essential for CagA delivery, which is mediated by specific binding of CEACAMs with the outer membrane adhesin HopQ of the bacteria.50,51,59,60 The CagL protein, a pilus surface component of the T4SS, has also been reported to be an adhesin that mediates CagA delivery by interacting with and thereby activating É?5β1 integrin on target gastric epithelial cells in an arginine-glycine-aspartate (RGD) motif-dependent manner.61 CagL stimulates SRC family kinase (SFK) activity, which in turn phosphorylates the delivered CagA.61 The É?5β1 integrin also interacts with other components of the T4SS, including CagY and CagI, which may cooperatively stabilize the T4SS-host cell interaction.62
To further facilitate the delivery of CagA, H. pylori induces the membrane phospholipid phosphatidylserine (PS) found in the inner membrane leaflet of epithelial cells to be exposed on the outer membrane.63 CagA interacts with the exposed PS to initiate its secretion into the host epithelial cell.63 ... ...
Portrait of Dr. Hatekeyama Symposium Presentation: Helicobacter pylori CagA as a bacterial oncoprotein
... ... Chronic infection with Helicobacter pylori cagA-positive strainsis the strongest risk factor for the development of gastric carcinoma. The cagA gene-encoded CagA is delivered into gastric epithelial cells by the bacterial type IV secretion system, although the underlying mechanisms remain uncertain. Recently, we found that direct contact of H. pylori with epithelial cells induces rapid externalization of phosphatidylserine (PS) to the outer leaflet of the plasma membrane. CagA, which is also exposed on the bacterial surface via type IV secretion, interacts with the membrane-externalized PS. The CagA-PS interaction triggers the entry of CagA into host epithelial cells, which also requires energy-dependent host cell processes distinct from known endocytic pathways.In polarized epithelial cells, delivered CagA is tethered to the inner leaflet of the plasma membrane again through interaction with PS. Thus, host membrane PS plays a key role in delivery and intracellular localization of H. pylori CagA. ... ... http://www.tmd.ac.jp/TMDU-e/isc/isp2010/abstracts/hatekeyama.html
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