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The eyes and ears team for bio trials

By , February 26, 2014

This discussion came about as the result of the GS thread ”This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug”

It is hoped that all/any that can throw light, can brainstorm here and feedback consensus to the thread. Good work Guys. my best Alan Harris.

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.

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roblites
March 14, 2014 11:20 am

Knock, knock is anybody home? I am Clueless whether this thread is still alive or I have to be an irregular to participate in some unknown, to me, location. Alan can U help?
And most importantly, why BNIKF is so down at the 14th open. Appears there was a 25K sell to drop the price for better buy because it is followed by a 30K buy.

roblites
March 14, 2014 11:21 am

testing.

KennyG
March 14, 2014 11:23 am
Reply to  roblites

Hi Roblites – – we are here, although most of the discussion is on http://www.stockgumshoe.com/2014/03/microblog-nash-an-all-too-common-liver-disease-and-a-company-aiming-to-treat-it/#comment-1294599 for the irregulars.

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Alan Harris
March 15, 2014 4:56 am

Well guys, I guess all good things must come to a close ( for me at least here). Lets look back at what we’ve achieved: We have encouraged (begged!) Dr KSS to start his own valuable column. Weve identified some interesting investment ideas (your money, your choice). Perhaps most importantly though, a diverse set of strangers have come together in friendship and tolerance to confer, share, help, educate, assist and debate, without the ya boo conflict that so dogs sites like Yahoo!. An important spreadsheet has been created which remains available for free. But most of the discussion will now move to the $49 GS Irregulars. Anyone who has ever bought a tipsheet will know that this is phenomenal value. In the unlikely event that anyone who has followed this and THE thread (see top ) simply cannot stretch to joining us there, email Travis (a smashing guy). I am not employed/associated with Gumshoe in any way other than as a happy customer, but I will personally stand 50% of your subscription for first year (first 20 people who have previously contributed a comment above or on THE thread).
Well, thats it from me here. Meet ya in the Irregs club.
Rgs Alan

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lskulow
March 15, 2014 6:15 am

Awe, Alan, what a nice guy you are! You’ve certainly been one of the essentials in developing both of these fabulous threads. When I first read “all good things must come to a close…” I was afraid you were leaving for some strange reason. Glad that’s not the case! See you over in the Irregs 🙂

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roblites
March 15, 2014 3:18 pm

“…….Israel’s Galmed ($GLMD) banked $38 million in a 2.8 million-share offering, pricing at $13.50 after upping its tender by 17%. The company’s lead drug, aramchol, is a synthetic combination of fatty acid and bile designed to treat nonalcoholic steatohepatitis (NASH), one of the industry’s en vogue disease targets. Galmed is working through a mid-stage study of the drug in NASH patients with obesity and glucose intolerance, planning to roll aramchol into Phase III in 2015.” Quote, FIerce biotech daily letter.

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👍 130
March 15, 2014 8:57 pm

About ScanCell, I would not buy. I don’t have time tonight to go into it, but will tomorrow. i have serious reservations about what they are doing.

👍 47658
March 16, 2014 11:52 am

About ScanCell: I am pretty suspicious this one will be a bust. Its approach is to have a DNA that encodes an antibody that will be recognized by macrophages, and the scheme is that this antibody will also have tacked onto it certain protein epitopes unique to melanoma.

So they shock that DNA into your muscle tissue, and have the muscle tissue produce the antibody, which goes to macrophages and teaches them to fight melanoma. This is nonsense. It is needless ornateness. They are gratuitously making it complicated to string investors along.

If they were serious about this, they would take that DNA clone, plonk it into cultured lymphocytes or into a mouse hybridoma model system, crank out the antibody and give that antibody as a drug. Their way of going about this is pure Rube Goldberg, designed to bumfuzzle investors. Needless complexity with no possible benefit at all from doing this the more complicated way.

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Susan Graham
March 16, 2014 12:32 pm
Reply to  DrKSSMDPhD

Dr KSS: but if it’s Rube Goldberg, how do you explain the results of the trial? It seems to work. Do you mean that it works but is needlessly complicated? And you have a simpler solution? Or?

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3932
March 16, 2014 1:38 pm
Reply to  Susan Graham

Positive results in a small clinical trial do not mean this is good science. if it works, what they should be doing is making the antibody as a drug and giving that. It would be vastly simpler than shocking people to administer DNA. Using muscle cells to crank out little bits of antibody is nonsense. Just give the antibody already. They are trying to make it ornate, complex, many-stepped, to dupe people into thinking this is exceptional treatment. We are in an age and an investing climate in which it is much easier to get investor capital from people without science backgrounds than it is to get grants funded (where science peers review your work). This company is just an outfit concocted by oncologists at University of Nottingham to fund their research. It is scientific fizzbin. They are doing it this way because it befuddles more people. To make antibody, there would be start-up costs, manufacturing on bigger scale. You administer therapeutic DNA as a strategy to cause cells to make cell-surface proteins that activate the immune system. You do NOT use it is as a way of getting cells to make a protein for export into blood.

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puritas
March 16, 2014 2:06 pm

Susan Graham

I am astonished by lack of understanding of DNA cancer vaccines shown Dr KSS. Cancer immunotherapy via DNA vaccines is an extremely hot area in investment at present. Scancell has shown in some key research that using epitopes on an antibody structure in DNA vaccines generates a far stronger immune response that programming dendritic cells to produce whole antigens.

The last thing that Scancell is doing is deliberately designing an unnecessarily complicate drug to bamboozle investors. The vaccine is designed by Lindy Durrant, Professor of Cancer Immunotherapy at Nottingham University. The ‘drug’ in this case is a therapeutic cancer vaccine called ImmunoBody. It isn’t unnecessarily complicated. Plasmid DNA is electroporated into mature dendritic cells beneath the skin’s surface. This is the standard way that DNA vaccines are administered. The plasmid is taken up by these dendritic cells and encodes for an Ig molecule with epitopes of cancer antigens fused to its effector arms. The dendritic cells migrate to the lymph nodes and the epitopes are presented via MHC Class 1 and 2 to killer CD8 and helper CD4 T cells respectively. This is basically the same as Inovio’s cancer vaccine but in one particular. Instead of the plasmid encoding for whole antigens (Inovio) it encodes for epitopes of cancer antigens within an antibody fusion protein. This has been found to generate a significantly more powerful T cell response than encoding for whole antigens alone as Inovio does.

Remember Scancell’s ImmunoBody is a vaccine stimulating an immune response NOT a drug. The intention is not to manufacture mono-clonal antibodies to carry drugs to tumours. The Ig molecule, in the instance of ImmunoBody, simply serves the purpose of forming a useful structure to present cancer peptides to T cells. And in this role it has been found to be more effective in generating powerful T cell responses than using whole antigens alone.

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Bibio
March 16, 2014 2:37 pm

Hi Susan,
There is a website here in the UK that hosts a BB for Scancell (SCLP) with a few knowledgeable folks that I am sure will be able to answer your questions in as much detail as you require.
http://www.lse.co.uk/ShareChat.asp?ShareTicker=SCLP

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Bobust
March 16, 2014 3:21 pm
Reply to  Bibio

Susan, if the above comments have caused you any concern it is also worth noting that Pfizer seem pretty keen on DNA cancer vaccines having just licensed Ichor’s electroporation device (the same device as Scancell use) to develop their own preclinical DNA vaccines

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Susan Graham
March 18, 2014 5:55 am
Reply to  Bobust

@Bobust. Thanks for that. I have had quite a week on this (SG) and the UK BBs! I found the site Bibio recommended helpful for the pro-SCLP views, and Dr. KSS provided another, straightforward response to my question, and then clarified his answer further. Politely. I went away for a day, and when I checked back, I found all the uproar. I am personally interested in SCLP’s work, not particularly financially, and to be criticised for asking a question and then for further clarification seems to me to be a bit much! I am holding the few shares of SCLP I have, not adding, and will wait to see what happens. I am unlikely to contribute materially to the discussion, because I don’t have enough expertise, but I do reserve the right to ask questions.

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welchtt
March 18, 2014 9:43 am
Reply to  Susan Graham

Don’t take it as a personal criticism, I read it as being directed at the research. Some of the guys here are doctors, who may themselves end up administering the products and therapies being developed. Their faces and signatures are behind the product so I understand they want to put these companies through the wringer. Personally after receiving all the “Oops we goofed!” mail from drug manufacturers (and our own family’s medical history/experience), I personally appreciate the skepticism and counter-arguments. Come to think of it the manufacturers are rarely kind enough to notify, we have to hear it from the various publications or 1-800-BAD DRUG commercials.

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sivapann
March 16, 2014 2:59 pm

http://groundreport.com/molmed-tk-therapy-submitted-for-conditional-marketing-authorisation-in-eu/

MolMed S.p.A. (Milan:MLM) announces that the Company has filed to the European Medicines Agency an application for Conditional Marketing Authorisation for TK, its novel investigational cell-gene therapy. TK is an adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia.

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March 16, 2014 3:33 pm

You are here, John Davis, to market the newsletter for which you have authored articles supporting ScanCell. My understanding of its technology is vast and deep as I have done extensive studies with electroporation using DNA plasmids. This approach to cause the system to crank out antibodies, no matter how endowed they are with special properties and epitopes, is dubious at best and utter high silliness at worst. I may be going out on a limb here, but I predict you have not cloned plasmids, done electroporation, assessed transduction, or harvested and characterized transfection products. You are here to hawk your $50 reports on ScanCell. Also can’t help but notice that your newsletter covers Dendreon, makers of the most absurdistly inane and ineffective, overhyped and fraudulent biotech product of this generation.

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puritas
March 16, 2014 4:25 pm
Reply to  DrKSSMDPhD

Dr. KSS,

You are typing absolute poppycock. I am not even that John Davis.

Just like Scancell’s decision to use Ig molecules as a structural device to carry encoded cancer mimitopes on their effector arms was coincidentally similar to the use of mono-clonal antibodies as fusion proteins for drug delivery my name John Davis is coincidentally the same as the writer of that report on Scancell. I wouldn’t pay $50 for it never mind market it!

You are obviously out of your depth holding forth on a subject you have little understanding of. It’s not Scancell that is bamboozling any one here, it is you!

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Irregular
March 16, 2014 5:01 pm
Reply to  puritas

So what are your qualifications John Davis? What do you do for a living?

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March 16, 2014 5:57 pm
Reply to  puritas

It is important to realize that we have become very aware of Dr. KSS qualifications and kind thoughts with recommendations. He has not come to us with over 2,000 discussion points without any solicitations, only helpful commentary. I find it very disruptive for an unknown solicitor to come forward attacking a person we have come to appreciate and respect with their purpose and agenda. Travis, I respectfully request SG block any future commentary from this intruder. Thank you.

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3932
March 16, 2014 6:03 pm
Reply to  Warner

Sorry, the second sentence should read “He has come to us with over 2,000 discussion points without any solicitations, only helpful commentary.”

newby3867
March 16, 2014 7:47 pm
Reply to  puritas

Mr. Davis we handle ourselves with a little class over here and your comments are way off line.Dr KSS has been great to us with everything.If you are not into this maybe you need to move on.

👍 6779
March 16, 2014 4:46 pm

Wow! Stock Gumshoe has gone international. Things are really heating up at that UK blog that Bibio posted as a link at #89. They are quoting Dr KSS and posting links.

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👍 644
March 16, 2014 5:17 pm

We are polite and gentle people here John Davis, and for you to come on here and open your comments with ad hominem insults and lashing out is unacceptable. We also here declare our positions in companies we discuss so that our motives are transparent.

Basing anything on a tiny open label unblinded trial is nonsense, and a whole host of interventions ranging from the trivial (lesional injection in melanoma) to the ornate (the ScamCell approach) evoke immune responses in melanoma (which I suspect you have never treated). Patients in the study did NOT have tumor regression, and some had tumor that popped right back out. Nothing is clarified about what other therapies these patients were getting, and even in the NHS there are other therapies approved for melanoma, and it would be unethical to withhold those from patients with stage III and stage IV disease. Non-progression may be one thing, but it is a long way from regression, and many lesser therapies approved or not have been shown to make melanoma regress. This one doesn’t.

This is a company working out well for an insider clique at Nottingham, with data that have been neither peer-reviewed, published nor presented formally. There was no control arm of any kind. The findings are barely interpretable and are certainly not a basis for investing. Scores of immunotherapy approaches to melanoma have spectacularly failed after promising initial results. Immune responses to melanoma can be measured in response to many things….probably even in response to injecting saline into a melanoma nodule. Meanwhile, implanting DNA to make a tiny bit of protein that could just as easily be manufactured is a lot like refusing to buy a vacuum cleaner and instead hiring a guy to buy the parts to one and having him come and sit in your house and build one for you. One uses therapies such as electroporation to generate proteins that need presenting as antigens in a cell surface context, proteins that may be membrane-integral, that cannot be replicated by exogenous administration. And that is definitely not the case here.

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👍 47658
March 16, 2014 5:45 pm
Reply to  DrKSSMDPhD

DR KSS; I remember once reading in a popular magazine that acupuncture was going to be the answer to cancer since it “Produced an immune response when the proper meridians were selected & protocols followed”……whatever that might mean. Barnum was right.

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inanaco
March 16, 2014 5:47 pm

.. Dr KSS are you from the US ?

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puritas
March 16, 2014 6:07 pm

Dr. KSS,

You began ‘your’ comments with ad hominem and unnecessary accusations against me; claiming that I was here to hawk a $50 report which I have never produced. Secondly you have made unfounded and scurrilous accusations against Scancell and Professor Durrant. I would love to see you try and convince a jury of that nonsense.

You have obviously made an error here in your understanding of ImmunoBody. What you should be doing is asking questions not pontificating as if you knew something about the subject when you don’t. The introduction of plasmid DNA into dendritic cells rather than introducing fusion proteins from outside these cells leads to a phenomenon called ‘direct presentation.’ Direct presentation elicits a far more powerful immune response than endogenous absorption of external proteins or peptides. When antigens or in this case antigenic complexes are introduced from outside dendritic cells rather than being produced by them via plasmid programming the result is a phenomenon called ‘indirect presentation.’ Indirect presentation produces an immune response but it is much weaker than that produced by direct presentation.

So you see manufacturing these fusion proteins and then introducing them externally to antigen presenting cells would lead to a less powerful immune response. Hence Scancell’s ImmunoBody DNA vaccine.

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Member
March 16, 2014 6:08 pm

It seems our Dr. KSS has kicked a hornets nest in the UK. What I don’t understand is — as an investor (vs. a pumper) I want all the relevant info and opinions I can get on a stock. Why is a divergent opinion so threatening? I hope here on SG we always welcome considered opinions given in good faith. And we always keep our cheerleading under control. That’s what I love about Travis — he gives his opinion, then asks for dissenting opinions.

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KennyG
March 16, 2014 6:28 pm
Reply to  bosley

Really, what this boils down to is that both parties have presented their opinion on Scancell and let those that still believe in it’s ability to perform as claimed continue with their investment. Those that don’t believe in it, invest elsewhere. This back-and-forth at times derogatory comments don’t belong in this thread. To this point it has been very civil with parties offering their opinions on various investments. John Davis – you are probably a fine chap who happens to disagree with the scientific viewpoints of Dr.KSS. Good luck to you with your investment. I think Dr.KSS was offering his viewpoints not as someone holding a short position looking to drive the price of Scancell down for his own gain. Rather it was an attempt to save some folks from losing their investment that in his highly educated opinion is based on bad science. If you or anyone disagrees – fine. Continue with your investment. It should end here.

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Bibio
March 16, 2014 7:28 pm
Reply to  bosley

Brad,

As an investor I also want all the relevant info and opinions. The problem with such an investment is that the complexity of the science requires a great deal of research and understanding, much of which is beyond me. On Blogs or BB’s we rely on those that have the relevant expertise to share their insight and opinion to explain the science. I’m not sure that such outright and wholesale condemnation of a Professor with 30 years of research and a whole academic institution is the stuff of constructive debate.

Here’s the Scancell (spelt with an n) web link.

http://www.scancell.co.uk/

I’m sure if you have any questions you will know who to ask.
ATB

March 16, 2014 8:06 pm

John Davis, whoever that is, will not identify himself or his position in this or what his qualifications are. He and Bibio are taking my posts over to the UK website, pasting them out of context and will negative comments thrown in to frame them, and then sniggering amongst themselves like adolescent wankers. I won’t respond to them anymore here or in any other forum. it is all hoi polloi sociopathy. I have given an honest view on ScanCell. It is not something I would invest in. The people at the other site are the sorts of craven bogans earnestly burlesqued in Martin Amis’s novels. Unlike these louts, I am honestly just doing this to be kind and because someone asked. I am not trying to influence people to enhance my own financial position the way “John Davis” is. Seems the Brits badmouth us and take us for fools in their forums. Perfidious Albion indeed.

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Bibio
March 16, 2014 8:41 pm
Reply to  DrKSSMDPhD

Dr. KSS, MD PhD

Thanks for that – I was hoping for a more enlightening response to the post by John Davis no. 94. Quite frankly what you think of me is neither here nor there and you don’t really appear to have managed to help any of us understand your point of view.

ATB

ATB

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3932
March 16, 2014 8:52 pm

You are beneath responding to Bibio. You are an abuser. Anyone wanting to see your “work” can see from the crassness of your postings on LSE there that a more detailed explanation would be a waste of time, pearls before swine, would fly past you, and then get rejiggered and misrendered elsewhere. You are a schoolboy imitating body noises on a crowded elevator.

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Bibio
March 16, 2014 9:09 pm
Reply to  DrKSSMDPhD

It’s your reply to the last one by John Davis that folks are more than likely interested in. Not mine.

ATB

Member
sivapann
March 17, 2014 1:29 am
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gloglo
March 17, 2014 3:12 am

Dr KSS I greatly appreciate your writing and time given. You have stated your interest and knowledge base, and its outrageous for the UK lot to intrude, bully, abuse and tantrum.
You give your choices (many thanks) and if questioned what you wont buy and if necessary why not. No argument is relevant.
I am glad to have the ASX stocks.

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