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Yes. Honestly I was surprised by that. Animal model or not, this is a big deal. This is the first study documenting evidence of complete cancerous tumor regression using a DNA vaccine. (To my knowledge at least).
Abstract Number: LB-253
Presentation Title: Control of tumor growth in vivo by a synthetic multi-antigen DNA immune therapy for prostate cancer
Presentation Time: Tuesday, Apr 19, 2016, 8:00 AM -12:00 PM
Location: Section 12
Poster Board Number: 9
Author Block: Bernadette Ferraro1, Jewell N. Walters1, Emma L. Reuschel2, Amritha Balakrishnan2, Matthew P. Morrow1, Amir S. Khan1, Niranjan Y. Sardesai1, Laurent M. Humeau1, David B. Weiner2. 1Inovio Pharmaceuticals, Plymouth Meeting, PA; 2University of Pennsylvania School of Medicine, Philadelphia, PA
Abstract Body: Prostate cancer (PCa) is one of the leading causes of cancer deaths among men with limited treatment options. Accordingly, new approaches, such as immunotherapy, may represent important approaches for PCa treatment. Electroporation (EP) delivered DNA vaccines has recently shown promising results for therapeutic immunotherapy strategies has been limited to single antigen and epitope targets with limited success. We hypothesized that a broader collection of antigens adjuvanted by plasmid encoded IL-12 would bypass immune tolerance and improve the breadth and effectiveness of a PCa immunotherapy approach. We tested this hypothesis in NHP for immune tolerance effects as well as in the highly relevant TRAMP-C2 challenge model. We developed highly optimized DNA vectors encoding consensus antigens for important PCa targets prostate-specific antigen (SynCon PSA), prostate-specific membrane antigen (SynCon PSMA), and human six-transmembrane epithelial antigen of the prostate (STEAP). In mice the vaccines demonstrated potent IFN? production by ELISpot (2740 SFU) and robust immune responses in the CD4+ (0.53%) and CD8+ (3.0%) T cell compartments. Further, sera from immunized mice reacted in ELISA with relevant targets and specifically stained LNCaP cells, a human PCa cell line, as well as human PCa tumor sections, supporting that the vaccine antigens induced relevant antibody responses. Vaccination of Rhesus Macaques, which share greater than 98% identity with humans, showed robust anti-PSA, PSMA and STEAP IFN? production (612 SFU), potential for cytotoxic T cell function, and antigen specific seroconversion supporting the ability of these constructs to break tolerance. The therapeutic potential of PSMA, STEAP, and the combination of PSMA and STEAP, alone or with the molecular adjuvant IL-12, was evaluated in mice in the TRAMP-C2 tumor model. Alone, PSMA, STEAP or PSMA+STEAP demonstrated prolonged survival and a modest impact on tumor growth. However, the combination of synthetic vaccine antigens with IL-12 resulted in 100% efficacy in treatment and clearance of tumors resulting in 100% survival. These data support further study of this novel immune therapy of PCa.
Isn't there a "gap" somewhere around $15? Let's fill that one next time.
I have to agree. I can't stand AF and he thinks he's much smarter than he is. However, he is right about ATHX. The stroke trial failed and they are now trying to spin something positive out of the 1 year follow up data. Maybe they will be able to swing something in Japan as I'm not familiar with their regulatory process. The FDA will not be impressed though. There may be enough to get to phase III due to good safety profile, but I've seen enough to be convinced the efficacy isn't there.
Disclosure: I used to own ATHX shares but sold after the IBD trial failure.
Guys, I hope you appreciate how big the lancet publication is. This is real validation, not some rinky dink journal.
Source?
The negative part of the corporate update was potential delay of pennvax-gp.
Nope. There was nothing new on the VGX-3100 partnering front. Kim has consistently said they are looking at partners but will go it alone if that is what provides the best opportunity.
This commenter's points should be well known by longs at this point. That being said, The main selling point is that Afrezza is inhaled and not injected.
We investors feel the need to bring up the kinetics to differentiate Afrezza from Exhubera and defend ourselves from the bashers. In the real world, the majority of (type II) diabetics don't give a damn about kinetics. They will be attracted by the fact that it's inhaled, easy to use, and portable. This is the main selling point, and this is what Sanofi will put front and center in marketing.
The kinetics do make the product superior and may be a selling point for some (type I) diabetics. However, we will have a blockbuster on our hands primarily because Afrezza is inhaled. If anyone thinks inhaled insulin isn't something diabetics want, then they haven't been asking diabetic patients. This is something they want, and it will be the easiest thing in the world to sell to patients. In fact, they will come in asking for it.
Reference: I am a medical student and I see about 10 uncontrolled type II diabetics every day.
Excellent news. TA's I'm sorry, but screw your gaps. They don't apply here. We go up now.
Wow that was quick, article already removed. Well done SA, but never should have been posted in the first place.
FYI a very quick internet search reveals the website mannkindtechnologies.com was created in November 2011. In fact, the website doesn't appear to have been updated since then based on the fact all the pages on the website are still copyrighted 2011.
I absolutely hate this article. The "new website" has been around since I began investing in mannkind over a year ago. How this article was ever published is beyond me. Seeking alpha really needs to do a better job of quality control. This article contains false information with a heavy dose of speculation, which is makes it an easy target for shorts to attack.
As longs, I think we need to get upset about fluff pieces like this that are based on false information and do everything we can to get them taken down before they are used against us.
Important Question: Why Amphastar France?
Amphastar is based in rancho cucamonga CA. Seems a lot easier to just do business with them there. Unless...
Also strange is the fact that there was only enough serum at first to treat one of two people who needed it. Why fly in just one dose? And how is more available a day later?
I get that there is a limited supply, but how is it so limited that only one dose was available. If it were a drug currently in preclinical or clinical trials, surely there would be more than one dose of it available. The only thing that makes sense here is multiple WBC donors. They mention the 14 year old survivor transfusion, but that plus the two doses already given is way too much blood to be drawn from a kid in such a short time span.
Also it seems like if they did give antibodies, they would administer a vaccination at the same time. This is standard practice for other deadly diseases such as rabies and tetanus toxin. Passive + active immunization is always used to fight life threatening disease after exposure.
Hopefully we get some more info on this soon, and it would be great if whatever they did works.
It is true that regardless of whether this is Inovio's vaccine or not, Pandora's box has just been opened for experimental drugs to treat deadly disease.
The NBC article linked to another article about different experimental therapies in development. If I had to guess, I would say that BioCryst's BCX4430 broad spectrum antiviral is the most logical candidate out of the treatments mentioned. It is an antiviral that can be used within 48 hours of becoming ill.
However in primate studies: "When given the drug 48 hours after infection, 5 of the 6 animals survived at day 30."
Update: didn't feel like erasing everything I just wrote but this looks like the most plausible explanation and would explain consistent use of the word "serum":
http://news.discovery.com/human/health/experimental-ebola-serum-likely-treating-sick-americans-140802.htm
Thanks for the update! Certainly interesting stuff. The part that is throwing me is that they are only using the words "experimental serum." Seems like a funny way to refer to a vaccine. No buzz words associated with Inovio are popping up like "therapeutic vaccine" or mention of an "electric shock" (doubt they would use the word electroporation).
It is certainly a possibility Inovio is involved, although it does seem like a long shot at this point. Inovio does have the advantage of good safety data for the DNA vaccine platform, so that could play to our advantage, ie if it is safe, why not try it and see if it does something?
Not seeing anything about this. Link? All sources I can find say that he refused the serum to let the other patient have it. Here is a summary of the info I was able to find.
http://www.georgianewsday.com/news/regional/272551-dr-kent-brantly-battling-ebola-passes-up-potentially-life-saving-experimental-serum-so-his-american-colleague-can-have-it.html?print
He's been going around bashing all the stem cell company boards. Must've lost a lot of money on his plays. Reminds me of when I invested in solar stocks and they all tanked. I got frustrated, sold all those positions, and then they skyrocketed. Stem cells will have their day, but patience is key. Got to keep a level head and trust nothing but the scientific evidence.
I will say that neuralstem also has a reasonable shot at good stroke results. Their approach is very different (fetal stem cells directly into the brain). I don't know which one of them will prove more effective, but I think the upside in either is worth investing in, so I am in both.
And it looks like funding is indeed the issue. From Inovio's website:
"Inovio is prepared to advance this program into a clinical trial, but the actual timing of the human study is dependent upon funding from MVI or other funding agencies."
Hopefully they can get the ball rolling on this soon. Would be a quick, simple, and very direct way to potentially validate the infectious disease pipeline.
Actually yes they would, as is described in the article I linked.
Ebola would be tricky to test. Malaria, on the other hand, should be simple. Anybody know what happened to the malaria challenge trial that was supposed to launch early this year?
http://www.path.org/news/press-room/134/
I always thought that this would be our proof of concept for infectious disease, and then it just fell completely off the radar.
Yup. She even had a sense of humor! Love to see that.
My trading style is probably very different than most on this board. I am more investment type, buy and hold oriented rather than frequent buy and sell. Because of this I am mostly unconcerned about price movement on a day to day, weekly, or even monthly basis.
This is mostly because a buy and hold strategy is easier, less time consuming, and a more sure fire strategy to execute as long as you research and truly understand the company you are invested in. For me, this means keeping up on scientific developments and reading all the papers published by the company that I can get my hands on.
That being said, I do appreciate the occasional intelligent post regarding the technical price movement such as the one you have offered. The posts that have no value are the the following:
"OMG why are we tanking. R/S was a bad idea. J Kim knows nothing about the stock market"
"Why aren't we at $15 yet??? Manipulation!!!"
"Why did he have to do the shelf offering? Killed the rally!!!"
Or on the flip side, "guys get ready for $25 right after data!!!"
My point is that Dr. Kim knows what he is doing. He went to Wharton. With no offense meant to any of the regulars on this board, he is thinking on a higher level than you are about these things. Granted, his eye is to the long term as opposed to short term.
And this is where I say he and management don't care about you. If you want to flip, that can definitely be a viable strategy if you have the time and know what you're doing. However, for the type of person who wants to buy now and have the stock go to $20 by the end of the week, this is not something J Kim has control over or is concerned about at all.
If you are in for the long haul, you probably like the way management has handled most things business wise and I believe we will all be rewarded handsomely for our patience. If you are trying to play short term, success is based on your own skill and knowledge of the market. Management does not owe you a random PR on Monday to temporarily boost your position.
Sorry for the long post, I'm sure most didn't read. Thanks to all who provide useful insights to this board. We are all in this together.
I'm seeing a whole bunch of whining here. Sack up, or get out if you can't stand the fluctuations. Inovio management does not need your advice on the reverse split, shelf offering, or when to release news to "prop up" the share price. If you don't agree with the way Inovio handles their business, then what are you still doing here? If you don't like it, move on.
I personally think management has handled things well in every possible way so far. They can't control share price and when the stock takes a hit on a no-news day, it is not a fault of the company. It would be great if everyone here could quit whining every time Inovio has a down day so we can make room for more intelligent conversation on this board.
Good thing their trials are not blinded
Is Inhaled Insulin a 'Game Changer'?
Matthew L. Mintz, MDDisclosures
July 23, 2014
A new formulation of insulin that is delivered via inhaler promises the elimination of needles for patients with diabetes. So why hasn't there been more fanfare over the anticipated arrival of Afrezza® (MannKind; Valencia, California)?
Many clinicians are skeptical about the inhaled insulin product, despite its approval last month by the US Food and Drug Administration (FDA). They may remember an earlier version of inhaled insulin called Exubera, which was produced by Pfizer back in 2006. Manufacturing of that drug was discontinued 1 year later -- not because it was ineffective or for safety concerns, but simply because too few clinicians were prescribing it.
Will this new inhaled insulin product fare any differently? Several arguments can be made for why Afrezza could be a true game changer in diabetes management, whereas other reasons suggest that it may not.
Pros
1. Insulin without injections is still something that patients want.
Despite the failure of Exubera, patients really like the concept of inhaled insulin. Although pens have made insulin injections significantly easier, they are still inconvenient, can be expensive, and, of course, can be painful. In fact, a fear of needles can be a major barrier to initiating insulin in some patients who need it. In addition, some patients have a negative perception of self-injections, associating it with the idea that "I must be really sick." Given that inhalers are used for common conditions, such as asthma or other chronic pulmonary diseases, inhaled insulin may be substantially preferable to injectable insulin. This could ease the process of initiating insulin and could improve patient adherence.
2. The new device is substantially better than the previous one.
One of the main problems with Exubera was that the device was enormous and difficult to use. MannKind's original device for Afrezza looked similar to an asthma peak flow meter, and it was a substantial improvement. However, mid-way through the development process, the company created an even smaller device that some have described as looking like a whistle. This design change delayed the approval process (because the FDA wanted to see data on the new device), but the final design is compact and reportedly simple to use.
3. The dosing issue has been resolved.
Both clinicians and patients struggled with the dosing of Exubera. Because inhaled insulin comes in a powder, the FDA requires dosing by weight, not by unit. This was incredibly confusing, because other forms of insulin are dosed in units. In addition, Exubera was available in 1-mg and 3-mg cartridges, yet the contents of 3 of the 1-mg cartridges did not exactly equal the contents of the 3-mg cartridge. With Afrezza, the dosing is in units, with a 4-unit cartridge and an 8-unit cartridge, and the conversion is essentially unit to unit. The Afrezza package insert contains a fairly simple dosing chart that suggests comparable dosing for patients who are converting from mealtime insulin injections to the inhaled product.
4. The barrier of lung function testing may be slightly diminished.
The Exubera prescribing information carried a significant warning about lung function, and prescribers were advised to get baseline spirometry levels before initiating the drug. But many clinicians do not have spirometers in their offices, which created a substantial barrier to prescribing Exubera. However, long-term studies of Exubera showed that lung function diminished only slightly after the first few months and remained stable after 2 years of use. Lung function returned to baseline when Exubera was discontinued, and the declines were deemed clinically insignificant. Similar results were seen with Afrezza. Although clinicians are still advised to perform baseline spirometry for Afrezza, which also carries a boxed warning, the context of the warning is for acute bronchospasm in patients with lung disease. This is quite different from a warning about an unknown lung function effect for all.
The Exubera label stated, "Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA." Contrast that with the warning for Afrezza: "Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients."
In other words, baseline spirometry is still recommended before initiating Afrezza (as well as follow-up at 6 months and yearly thereafter). However, because the likelihood is fairly low that asymptomatic nonsmokers have lung disease, clinicians may view this advisory more liberally if spirometry is not readily available in their office.
5. Weight gain and hypoglycemia risks are lower with Afrezza than with other insulin formulations.
Type 2 diabetes is essentially a combination of glucose overproduction, insulin resistance, and beta-cell dysfunction with diminished insulin production. All therapies for diabetes work on one or more of these mechanisms. The problem with exogenous insulin and agents that increase insulin production (primarily sulfonylureas) is that they also lead to weight gain and bouts of hypoglycemia. The latter is particularly concerning, because severe hypoglycemia can lead to hospitalization and even death. Although Afrezza is associated with some weight gain and hypoglycemia risk, these risks are substantially lower than those associated with sulfonylureas and injectable insulin. In a study comparing Afrezza with insulin aspart, patients receiving Afrezza had almost one half the number of severe hypoglycemia episodes, and they actually lost weight compared with the insulin aspart recipients, who gained weight.
Cons
Despite the positives of this new inhaled insulin product, there are still 2 main reasons why Afrezza might not overcome the resistance among clinicians and patients that Exubera encountered.
1. Cost
Afrezza will probably be expensive, and insurance companies are restricting coverage of such new agents more than ever. Even if the manufacturer provides coupons to reduce patients' out-of-pocket costs, insurance companies may require proof that patients' disease cannot be controlled on injectable insulin.
2. Inertia
Many endocrinologists believe that injectable insulin works quite well, so it may be difficult to convince them to prescribe the inhaled product. And primary care physicians may be reluctant to try something new, especially when they are already pressed for time when seeing complex diabetic patients in a 15-minute visit.
From yesterday, one of the better articles I have read about Afrezza's prospects from a clinical perspective:
http://www.medscape.com/viewarticle/828463
Not sure about VGX-3100 partner. Based on the Roche abstract being presented today, you can bet on a partnership there for checkpoint inhibitor combination in the near future.
Wow. Thrilled about HPV clearance rate.
Haha, I like your style EMan...
One thing that I'm curious about. Most of these transactions occurred on the 27th of July. Why are they just now being filed? I always thought they had to be filed within 48 hours.
Cave, I like to give the benefit of the doubt on these things too. But even if someone doesn't understand the tax maneuverings going on, there is no way that person could think anybody sold all of the shares they added. The numbers just don't line up.
Plus shorts always seem obsessed with criticizing Diane Palumbo's automatic sales. Why, I don't know. She owns over $2 million worth of stock. How much does she need to own before people are satisfied?
Btw I'm not trying to defend dr. Tran here. His article bugged me too and I think his YouTube videos are creepy. If you haven't seen them already, search for "in Al Mann we trust" on YouTube and that should lead you to his profile.
Ok, you want to be really honest about things?
The only two people who sold were Palumbo and Thompson. Both still ended up acquiring a significant amount of shares as a net result of the combined transactions listed on their form 4's.
Everyone else who you claim "sold" had a portion of their stock options withheld in order to pay for taxes associated with acquiring the other shares (transaction code "F"). Again, the net result here is acquisition of a large amount of shares.
Nobody sold all of their shares. Only two sold any. All significantly increased their stake.
Older docs are very reluctant to prescribe new medicines. However, I think they will come around. Here is one reason why.
Many type II patients are on sulfonylurea oral medication. The entire point of these medications is to increase the release of endogenous insulin to avoid having to inject exogenous insulin. The problem here is that these drugs stress pancreatic beta cells, and cause a decline in beta cell function over time leading to poorer glycemic control.
On the other hand, exogenous prandial insulin gives the beta cells a break during mealtime and has a protective effect on beta cell function. Over time, an increase in beta cell function is seen when a prandial insulin is used.
Exogenous insulin is superior to endogenous. I believe the reason oral sulfonylureas exist is to avoid insulin injection. I see Afrezza taking a lot of this market, which is currently a very, very large market.
I have a feeling the authors replacing "long acting insulin" with "long term insulin" know exactly what they are doing. Almost every other thing is copied directly from the PR. Anyone else seeing this?
I am a medical student doing clinical rotations. The clinic I am at now sees a lot of type II diabetic patients. I can vouch for the fact that the vast majority are poorly controlled, with typical fasting ranges from 180-220 and often higher. It is very rare to see anyone close to the 90-110 range.
These patients are usually on metformin and a sulfonylurea drug like glipizide. Current literature would suggest these patients would do well with intensive insulin therapy. However, they don't want to inject themselves with insulin and their doctors are afraid to take on the increased risk associated with insulin therapy.
A lot of these patients and their doctors are not currently aware of Afrezza. As word gets out, I believe both doctor and patient will see Afrezza as the best way to start poorly controlled insulin naive T2DM's on an intensive insulin regimen. Insulin naive type II patients are by far the largest market opportunity that exists in the diabetic space, and I think this is where Afrezza will really shine.
Approved for both types