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RK MATTERS: I would appreciate your expertise/input on this news, is this something we should be worried about?
ImmunoGen says that in coming months it plans to test its experimental cancer drug in combination with Merck’s drug, Keytruda, after mouse trials done internally at the company — confirmed by academic studies — show the two drugs may multiply each others' effects.
Ever since the FDA approval last year of lung cancer drug Keytruda by Merck & Co. (Nasdaq: MRK), one of the first two so-called immunotherapies ever approved to harness the immune system to fight cancers, there’s been no shortage of drug makers eager to test how well their drugs work alongside it.
But in an interview yesterday, ImmunoGen (Nasdaq: IMGN) CEO Dan Junius told me that “I think we’ve got a little different play on it.” That’s because there’s evidence that the cancer-killing agent used in the Waltham biotech’s drugs, called maytansine, when used together with Keytruda, may help reprogram the body’s immune system to reject cancer in a different way than Keytruda alone.
“We have preclinical work showing if you combine Keytruda with maytansine it seems to have a profound effect,” he said.
Junius says outside academic studies not only confirmed that ImmunoGen’s approved drug partnered with Roche, Kadcyla (which also uses maytansine) seems to have a synergistic effect with Keytruda. The researchers found that mice treated with both seemed to reject the tumors even after they were reintroduced, suggesting the immune systems of the mice were reprogrammed to an extent. The scientists believe that the maytansine spurs a part of the immune system called dendritic cells, which amplifies the immune response caused by Keytruda.
The company is planning to expand an already-planned Phase 1b/2 trial that will test its ovarian cancer drug, mirvetuximab soravtansine, in combination with other drugs to include some patients who will take it in combination with Keytruda. Initial results of that trial will likely come in 2017.
The announcement helped boost ImmunoGen's shares by about 5 percent
Appreciate your input
Thanks
BLU
Well we are supposed to be in deep negotiations on partnership, funny how this comes up right now as news should be dispersed.
That's my guess/hope I am right, maybe they are close to announce.
BLU
Interesting: DEFINITION of 'Confidential Treatment Order - CTO'
An order that provides confidential treatment for certain documents and information, that a company would otherwise have to file. A confidential treatment order (CTO) is issued by the Securities and Exchange Commission (SEC) and may only be in effect for a certain period of time, rather than indefinitely.
BREAKING DOWN 'Confidential Treatment Order - CTO'
Companies would typically seek a CTO in order to keep information that would otherwise put it at a disadvantage, a secret. For example, a company may apply for such an order to keep information regarding a pricing arrangement made with a partner, secret, since competitors finding out this information may go after the partner with a more competitive price.
When did John first mention partnership, seems to me it was in the second or third quarter of 2015?
Are we close to finding out details.
BLU
Great question, Sept 15/2015 was the date the grant was issued, I expected news/CC in regards to SABCS data, so we are 4 1/2 months into the grant. We have had little to no news since the grant.
I also find it strange that they were not right on the ball once the grant was issued to ramp up finding clinical sites, clinicians. They must have multiple candidates waiting for treatment, but do realize that patients must go through rigorous screened to ensure they are compatible...dosing etc.
They definitely must be in a quiet period, because we have had no updates in 5 months, the fast track designation will certainly help in any partnership talks. Good thing it was not finalized before.
I believe that is in our benefit that the talks have taken so long, in my opinion that means Glynn did not jump at the first offer on the table.
Maybe there are multiple suitors, either way we must be close to news as others have mentioned each day that goes by brings us that much closer.
We are all in the dark here anything is possible, but I don't believe a buyout is in negotiations right now.
Lets just hope that they have put the last 4/5 months to good use, and when news comes they have something substantial to say.
BLU
TP, I do believe that it is a combination of both scenarios but like I said each piece that we put in place now only accentuates our position when time to up-list comes to fruition.
When we are ready Orphan, Fast Track two possibly three Phase 11's partnership in place, should have plenty of cash at that point [milestones/upfront monies]
And lowest cost to produce the funds may/will be drivers of the stock, if interim data is stellar at that point we should see double digit SP driven by funds.
Frustrating at this point as we are so very undervalued, but the SP will catch up once trials are up and running.
Data will be our only concern, and since commercial vaccine should be even more potent, hopefully the results will be in line [can they be any better?] with Phase 1's.
BLU
Which only means investors will be looking for [what may be a handful]of solid companies with outstanding future potential...a plus for us not a negative.
BLU
The greater good here is that each milestone Tapimmune achieves despite how small [regardless of whether the market "at this point"] gives us any street cred, is still actually great news.
Initiation of multiple Phase 11 trials plus partnership will give us strength when eventual up-listing happens. Whether we achieve it with great data and a series of company milestones, it makes it harder for the market to be negative. And much more prone to jump on board and not off and accelerate SP at that point.
If we have cash in bank [partnership agreement] and two Phase 11 trials up and running by end of year, that would be the time for up-listing. The company will be in a very solid position and the market will have little to no reason to deny a bullish future outlook.
That is when we should really see the price appreciation.
They are doing everything right at this point, remember they are submitting a "commercially" viable product into the Phase 11's, which should be even more potent than Phase 1 vaccine.
Timeline as it stands should give us preliminary Phase 11 data on TNBC and Ovarian by year end.
It was last Feb that Edith Perez did video on Tapimmunes vaccine being a game changer [almost 1 year too date] believe that there is much going on that we are not privy too.
Once again don't lose sight of the fact that our vaccine is so low cost to produce, we have many positives moving forward and really little to no negatives at this stage.
One day at a time.
GLTA
BLU
It doesn't need to do much, it is the sum of all parts that will propel the stock in the future.
With negotiations underway the DoD grant followed by Orphan Status and now Fast track it bodes very well from a bargaining position.
The FDA are one of the most time consuming/wasting entities when comes to granted trial approval so it is a big deal in that regard.
Also the last two approvals seem to show clearly that the FDA is on board with Tapimmune and it's direction and products.
It's like a puzzle we have another positive/relevant piece in place each individual piece, may not by itself be game changing but the sum of all parts is starting to show a clear and relevant story.
Very good news for the bargaining position they are involved in at the moment.
GLTA
BL:U
The one you PM'd me about AD..
BLU
Think the upside is in TPIV, 50,000 nice position [personally 4X that] feel the risk/reward between the two is Tapimmune not being biased.
Too many near term catalyst's in TPIV to ignore.
Would buy more TPIV on any more weakness or in this area, if you have disposable funds...60cents versus $6 plus your call.
This is a TPIV board can't elaborate, you get the gist,
Hope that helps.
BLU
Drivan: I don't have PM, so in answer to your question there are things I like about your query in question. But if you are asking if your query or adding/buying TPIV I would go with TPIV.
Believe that we have just encountered the tip of the iceberg on Tapimmune, we are in the space that everyone covets, and seem to have the leading Tech/science.
On your other query would wait for more news stabilization, you have to ask yourself which has the most explosive upside, and believe Tapimmune has just that.
Cost averaging much lower with TPIV.
GLTA
BLU
Thanks very much for those heart felt thoughts, he is quite small for his age, but also quite intelligent [Math particular], yes children are quite resilient.
Don't know yet whether his one leg will be shorter than other, he is at great University {McMaster] for physio recuperation they allow families to stay for extended periods, like McDonald house.
Once again appreciate sentiments, going to show him posts...he'll flip seeing his name on the net.
With 25 grandkids, always something going on...bless them all.
BLU
4 1/2 months since DoD gave Mayo the 13.3 million [Sept 15/2015] you would think that they would be close to finalizing Phase 11 initiation.
When news starts flowing, number of catalyst's to spark SP.
BLU
Thank You...simply one of many great contributors on this board, we are all here for two reasons.
Those who have been touched by Cancer and are committed to helping find a better alternative to existing therapies, and in our own small way are helping to achieve that end result.
And on the flip side, investing in a great technology that holds extreme promise to achieve that goal and along the way may allow us to benefit financially. So that we may be better prepared to take care of our families if/when such a terrible disease [s] attacks those that we protect and love.
Case in point, one of our grandchildren Carson [10 years old] on the school playground [Friday] broke his femur bone in three places and broke his ankle, when a larger child fell on his leg.
A freak accident...a child breaking his "femur" crazy putting in rod, plate and screws as we speak.
Says he is going to need a 4 wheeler to get around now...LOL.
Best of luck to all.
BLU
Biography of Frederick G. Wasserman
Age : 61
Public asset : 1,603,310 USD
Linked companies : MAM Software Group Inc. - DLH Holdings Corp - National Holdings Corporation - SMTC Corporation (USA)
Summary
Mr. Frederick G. Wasserman, CPA, is Independent Director at National Holdings Corp., Independent Director at SMTC Corp., President at FGW Partners LLC, Independent Director at MAM Software Group, Inc., Non-Executive Chairman at DLH Holdings Corp., and Chief Compliance Officer at Wynnefield Capital Management LLC.
He is on the Board of Directors at National Holdings Corp., SMTC Corp., and MAM Software Group, Inc.
Mr. Wasserman was previously employed as Independent Director by Gilman Ciocia, Inc., Independent Director by Breeze-Eastern Corp., Independent Director by ACME Communications, Inc., Chief Operating & Financial Officer by Mitchell & Ness Nostalgia Co., President & Chief Financial Officer by Goebel of North America, President & Chief Financial Officer by Papel Giftware, Inc., and Senior Vice President-Finance & Administration by Score Board, Inc.
He also served on the board at Crown Crafts, Inc. and Allied Defense Group, Inc.
He received his undergraduate degree from The Wharton School of the University of Pennsylvania.
Current positions of Frederick Gerald Wasserman, CPA
Name Title Since
MAM Software Group Inc.
(Software) Independent Director 2007
DLH Holdings Corp
(Business Support Services) Non-Executive Chairman 2007
FGW Partners LLC President 2008
National Holdings Corporation
(Investment Banking & Brokerage Services) Independent Director 2013
SMTC Corporation (USA)
(Semiconductors) Independent Director 2013
Wynnefield Capital Management LLC Chief Compliance Officer -
Holdings of Frederick Gerald Wasserman, CPA
Name Equities % Valuation
MAM Software Group Inc. (MAMS)
Software 127,225 0.88% 884,214 USD
DLH Holdings Corp (DLHC)
Business Support Services 162,125 1.70% 680,925 USD
National Holdings Corporation 10,482 0.084% 29,559 USD
SMTC Corporation (USA) (SMTX)
Semiconductors 5,556 0.034% 8,612 USD
Frederick Gerald Wasserman, CPA: Personal Network
Name Linked companies
William J. Recker DLH Holdings Corp
National Holdings Corporation
SMTC Corporation (USA)
Dwight B. Mamanteo MAM Software Group Inc.
Wynnefield Capital Management LLC
William Lerner National Holdings Corporation
Richard K. Abbe National Holdings Corporation
Peter H. Kamin MAM Software Group Inc.
Mark Harry Goldwasser National Holdings Corporation
Salvatore Giardina National Holdings Corporation
Gerald M. Czarnecki MAM Software Group Inc.
Frank S. Plimpton National Holdings Corporation
Glenn C. Worman National Holdings Corporation
BLU
Hi, With the data that has been achieved to date, the validation of the DoD grant, and the fact that they achieved such a high level of response in all participants.
I would expect that they will get monies up-front to advance trials, and substantial cash milestones for each trial level achieved.
Partnerships we have seen to date have been quite generous, and reflect the space we are in, I am bewildered to date as to why we have not garnered more attention.
We seem to be in a better place than the Alligator deal, as I mentioned I think the structuring of the deal will tell us much.
I must admit I really am baffled at this point in time, is there something that we are missing? The low cost factor itself should have given us the edge, I think as others have noted the market may be waiting for validation on initial Phase 11 data.
Many companies fail in second/third phase.
I really can't figure it out, as the low share price is astounding, and the fact that they did not have enough confidence in their science to stick to their guns on the warrant structure was not confidence building. And the market has let us know.
Glynn thought he was doing the right thing at the time, as the company almost went bankrupt.
If most of the overhanging warrants are truly gone, than substantial news should carry the stock price to respectable levels.
They have done little to instill confidence in me, and I really believe in the science, but if the science/Data is sound then there will be a point where the scales finally move in our favour.
Patience is wearing thin...but that's why patience is a virtue.
Not much help I know, but believe that we will get there eventually.
BLU
This is the problem with not disseminating information, it breeds doubt even in the staunchest of believers.
They heavily diluted our shareholder value with the premise that they would be expediting trials and company progress in general.
They have done anything but.
I still feel completely confident in the final outcome of Tapimmunes future, and firmly believe that they have a game plan in place once partnership is announced.
They need to get Phase 11 up and running on multiple fronts, to give preliminary Phase 11 results, so market knows that science is indeed sound.
Like I have mentioned before many companies with multiple Phase 11 trials, have at one time or another seen share prices in range from $8 to $15.
The structuring of the partnership will tell us much as to future potential of our investment.
BLU
There is certainly a disconnect between management and shareholders, this has been a problem with Glynn since inception.
Scientist's just don't get the corporate/people aspect of keeping existing shareholders properly informed.
Should have been an update after SABCS, and even being in a quiet period [if so] there is no reason why we haven't been updated on progression of trials.
My thought/hope is that they have a game plan in place to significantly enhance stock price by announcing partnership and following that news with initiation of trial news.
I worked 13 years with Barclays bank, and even wrote an occasional piece for Barron's [commonly referred to as "The Bible"] of investing.
They heavily diluted individual investor shares to raise monies to expedite game plan, yet we continue to fall farther and farther behind in trials.
Much of that is due to Mayo's protocol's which take much longer to implement, and there reluctance to release data until it has been dissected from every possible angle.
Working with the Mayo is both a blessing and a curse in that regard.
With all the time they have wasted...they should have a significant game plan in place we shall see.
GLTA
BLU
Whatever happened to end of Dec 2015, first week of Jan 2016...did you ask him that!
What exactly did he say?
BLU
I am wondering if it is Dart that is holding up the negotiations, I would think he would have a great deal of input in final decision.
He is a seasoned investor so hope that he is holding out for great terms. As each week that goes by, yes believe that we are indeed in a quiet period.
Trading has slowed considerably hopefully most warrants have been dumped, but if we get another day[s] of million plus pressure that scenario will be out the window.
Should be filing 4th quarter [year end] within 3 weeks Feb 14th, hope we get the news before that, there should be 2 or 3 PR's on pending news.
Best wishes to all of you in storm areas, LOL I live in cottage country and we have had 3 feet plus of snow for over 2 months now.
Be safe.
BLU
Just MM's taking their "pennies" of flesh, walk it up, then walk it down.
Donna's run for Breast Cancer [TNBC] has raised over the past years approx. $10 mill, in essence mayo had no Oncology and or Immunology dept.
Donna's run allowed Mayo to really progress in those areas, think she is a third time TNBC survivor, she has been instrumental in Mayo and Tapimmunes success to date.
A very courageous woman and great advocate for Cancer.
BLU
2Day, Thank you, and you also are right on point, as anyone that has been reading my posts knows I have championed Roche from the outset [not to say I am correct]
And I have also said that the lowest cost to produce may very well be the deciding/defining factor, they do need to ramp up their trial progress[s]
All good points thanks for reiterating them.
We really need an update to let everyone know that the science is still on track, my thinking is that they are in a quiet period.
BLU
RK I am of the same mind, I would rather wait till end of 2016 for deal as I have said, let 2/3 trials be up and running, Phase 1 polystart initiation, and new presentation of longer/increased data of non recurrence of science.
Wait and see if the final commercial product is even more potent/stellar than earlier Phase 1 presented data, Phase 1 may not have been the most viable product they have.
That's what I am saying if deal is not great...wait!!!
Unless there is a billion plus deal on the table at this moment why not struggle till end of 2016, when may be in a much stronger bargaining position.
Unless it is already better than what news has already been disseminated into the market.
Right now it seems that we are in limbo.
Always appreciate your input, always in-depth and on point.
BLU
I respectfully disagree, Glynn has been through hell with Tapimmune, if it were just a collaboration the deal would be done.
I don't believe after the DoD grant that Glynn will accept a deal without upfront compensation. If the science is as great as he says it is [and he has] why would he accept just a collaboration when he is fully aware of the deals done in the past two years.
That in my opinion would be an injustice to everyone involved and send a very negative message, the fact that it has/is delayed/cancelled is not a negative at this point.
They have cash, with more warrant cash if needed, possible grant monies. I personally would wai,t unless deal is very beneficial to Tapimmune and as you say RK wait until end of 2016 when new data is presented, and trials are up and running.
The possibility of an outright buyout by the end of 2016 would have much greater possibility, the near term science data is crucial [6 months out]
They have come this far, unless something has changed in the science it would not be prudent to limit themselves with a fair deal. When in 6/9 months the story will have changed considerably for the better...or worse.
The question is, is it worth the wait?
Having followed them for over 6 years, and being witness to all the ups and downs, if I ran the company, I would remain stalwart in my convictions.
Believe it would be short sighted to take deal that does not show the market...look at us we have the goods and the terms of the partnership proves it.
Just my thought, not by any means saying your wrong...but certainly hope you are...LOL.
GLTA
BLU
Thanks TP!
BLU
Goines...Well put, I could not have said it better. If the science holds, the future indeed is bright.
First for the millions maligned with Cancer, and secondly for those of us that have chosen to support such an important endeaver.
BLU
That's ridiculous, Glynn is well aware of Dick he has been a champion of Tapimmunes from the outset.
I have spoken to him on many an occasion and I know Denis [Corin]very well there is nothing going on in regards to Dick calling.
Over the years I have often got to know CEO's of companies at very early stages [bridge financings] etc, and find nothing irregular. Dick doesn't have much pull but his heart is in the right place.
Relax everyone is blowing this out of proportion.
If the stock gets into trouble it sure wont be because of Dick.
BLU
Dick has been around for many years, not a new piece of the puzzle. Any news that he has would/will be old news, we all know that news should be imminent.
But Dick is a good guy, but he is one guy not a promotion team.
GLTA
BLU
Just a note...Tapimmune a short year ago was on the verge of going bankrupt, management and a few of us shareholders at the time financed [bridge] and along with Ken Dart were able to keep it afloat...because the science was so compelling.
No one should be alarmed, anyone who has been an investor for any substantial amount of time knows that in the Bio tech world "nothing" gets done on time.
I cannot/will not speak for anyone else on this board but unless you invested in Tapimmune for a quick buck, relax and disseminate the facts.
We all know that it would have been fruitless to bring out any press in the final stages of 2015, management is confident of the science, and so are the Mayo and the DoD.
We can not control those who are not concerned of how valuable Tapimmunes science is, and trade purely for profit, Bio Tech's by nature take anywhere from 5 to 11 years to bring a drug to market.
Am I disappointed in the delays, of course, but I realize that until they get the 2 Phase II's up and running we will still be subject to heavy scrutiny.
We cannot control others agenda, by end of 2016 we will be completely validated. I would rather the partnership take longer and get the benefit/structure we deserve.
The overall market has been horrendous the past 8/10 days, anyone versed in Bio's knows it is a long haul. But the benefits if successful are enormous.
The fundamentals of the company have never been stronger, and they are seem to be on the cusp of something very special.
It is just a matter of time before this company breaks out, don't buy into something that isn't there...delays in business are inevitable. So in all walks of life.
Management should be in the drivers seat with the partnership, and when announced will end any and all speculation to Tapimmunes future.
In the meantime we are/will be subject to manipulation, keep your window end of 2017 as I have stated all along.
There is little chance that the likes of Edith Perez, Keith Knutson, Mayo, DoD, Dart and many others are all wrong and the manipulators are right.
This will come to an end and it will be sooner than later...patience as we all know the best is yet to come.
Look at these prices as opportunities, embrace those that are giving you the chance to either average your positions or simply add.
We cannot control the market or individuals in it, or there agendas, simply do the best DD we can.
Once again fundamentals have gotten stronger, not weaker. Nothing is guaranteed know your risk tolerance and live life within it.
GLTA
BLU
They have mentioned "partnership" for some months now, and NY cancer Center collaboration, but have not eluded to who it actually is.
That is one of the big news releases we are all waiting for, I hope that they have multiple catalysts in the hopper. And will start to disseminate them staggered every week or two in succession.
LOL If he's been eating his Wheaties then he will give presentation as "Glyness" AKA reference to Caitlyn Jenner.
He was the poster man...now a woman for Wheaties when I was a kid...in the 60's.
GLTA
BLU
So who is it?
BLU
Where has the partnership been listed?
BLU
Would be great to get news on partnership "pre-market" Monday, then give webcast with particulars...at this point I would settle for what Glynn had for breakfast.
We need news badly!
BLU
Goines: Most articles written by Seeking Alpha are usually very suspect at best, after reading the post it seemed to me as more negative than positive.
Not mentioning many or really any of the near term positive catalyst's, every positive had an underlying tone of negative connotation.
Seemed to have an agenda to me.
Robert Florkiewicz is Tapimmunes intellectual property agent, would not fret management is fully aware of protecting the assets. Most important issues were/are/have been addressed/protected by them and Mayo.
Patience good news seems to be just around the corner.
BLU
Thanks Buddy.
BLU [AKA Shawn]
HAPPY NEW YEAR TO EVERYONE...GOD BLESS
BLU
And that has relevance to the future of the company "How"?
No sellers here,your words fall on "deaf ears' not "dumb"
Correct TP
BLU