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here's the article if you wish to read it:
https://www.futuremedicine.com/doi/10.2217/imt-2017-0096#.WfxpifJlX1g.email
He was talking about the Journal as a whole be published which isn't for weeks yet.
you said that last year jass
It's actually a company rebuilding after a 1.8 billion dollar fine for insider trading in2014. It used to be SAC Capital, but management has been replaced and new culture is being revitalized with better training and security.
YW ZINO
Presentation will be around 12-1 AM., Central Standard Time--since Australia is 15 hrs. ahead of us. We could easily see PR first thing tomorrow.
hschlauch:your post sounds like my 6/13/2014 post:
(it's like a look back to the future --to where we are now!)
G...U...N GREATEST UNMET NEED.
The more I listen to P & P (Punit and Pierce), I hear them saying ONCS is not looking for a one trick pony. Meaning--they're not looking for a buyout in melanoma. They think they are going to be needed to drive immunogenicity to reach that 60-80% of non-responders—and not just in melanoma.
There is also the fact that most all the other cancer indications besides melanoma, have an even worse immunogenic response, some as high as 90 to 95% that will be unresponsive even to the best of drug treatments out there.
OncoSec has a very unique position in this rapidly developing immunotherapy. In the 26 months I've been invested in this company's vision, it has evolved tremendously. At one time (2012) it was all about the reduction of toxicity of Bleomicin (many newbee's here don't even know what that is) by using electrical pulses that powerfully increases agent uptake. We all thought buyout. But then the business plan changed. Along came IL-12 (2013) with different working mechanism of activating the immune system, and really--to their surprise--Systemic Response. So the business plan changed. NeoPulse, MCC and Lymphoma take a back seat in development and ImmunoPulse takes center stage. Then another unexpected surprise--immunogenic conversion that Meets the Greatest Unmet Need in Cancer Research To Date. And now the business plan changes again.
Now we have have a product that is no longer a one trick pony to melanoma alone. Powerful local treatment, Powerful Systemic Effect AND Powerful Immunogenic Mechanism of Change that can be of great value by providing enhancement to so many drug efforts, while converting the unreachable to the treatable. And Yet another business plan change. Molecular R&D for Drug development (This is new to ONCS for those new to the scene.
As Pierce has encourage his listeners--"I hope you can get your head around this." With OncoSec we are literally watching the birth of a breakthrough in Cancer Treatment across all indications that will benefit Millions of suffering people.
You can understand now why P&P are declaring "Leader in the Industry" and other exclamations-- literally being a "game changer."
I understand selling stock if your trading style is day trading, BUT if your selling because you're loosing faith--Not to worry. OncoSec is an underdog that will see it's day and be a Blessing to the suffering and dying like never before in the history of treating Cancer.
May God Bless the efforts of the OncoSec Team with streamlined wisdom, knowledge and understanding to get their jobs done well and efficiently!
Two Week later on June 30, 2014, I posted this:
ONCS already has CE approval in Europe, China, and Australia. They've halted NeoPulse trials due to a change in their business plan regarding immuno pulse, mechanism of change, cancers greatest unmet need, and now new drug development. ONCS pipeline has now become complex due to the fact that they haven't thoroughly understood the surprises that of come with IL – 12, meaning how they are getting a systemic response – how they are converting a nonresponder environment into a responder environment and being able to describe what's happening at the molecular level. They're just figuring this out right now. And that's why I think big Pharma isn't just jumping on because nobody really truly understands what's happening at the molecular level-- hence the slower progress with the FDA and trials.
I also think what is coming to light with Oncosec is so dramatically going to impact cancer research and treatment. Just think about it, everybody understands we're on the verge of cancer breakthrough in dramatically increasing the volume of cancer patients that will respond to treatment and Oncosec just so happened to find itself right in the thick of it with electroporation and IL 12. Big Pharma is scrambling with multiple trials going in multiple directions unsure of which will truly yield the golden egg because even they don't know. And oncosec is holding a good portion of that golden egg by demonstrating it's potential to turn up to 90% of nonresponders to multiple cancer indications into responders – that completely changes the face of the cancer population and the marketshare from a five billion-dollar industry to a 35 billion-dollar industry. So don't go thinking "no good news" or that there's nothing at stake here – this is the biggest development in cancer history that were looking at right now with oncosec as a combination or mono therapy treatment.
They are retooling everything, staff, electroporation applicators, destinations of treatment within the body, outcome objectives, a test that differentiates low till environments that require a combination treatment from high till environments that can be treated with a monotherapy. We are just going to have to wait and let this new business plan and it's process unfold before our eyes. There's a lot of thought and energy going into projections-- from projections of daily PPS movement, to FDA decisions, to potential results regarding the greatest unmet need, to partnering or buyout, or what the new multiple-molecule development program is going to bring about.
--"so hold on loosely, but don't let go, if you cling too tightly, you're going to lose control!"
--Waitforit!
Only since June has OncoSec introduces "tavokinogene telseplasmid" to describe IL-12, anyone know why now?
I take it those patients are from the responder population?
Since they are running the trail, it's possible they could release partial data anytime they choose correct? Say, at the three-month mark?
It was posted about an hour ago by RLC to Punit at the biotech investor board.
Is this the new multi-molecule they were talking about last year?
Chick, I think the reason PD didn't PR this was for a couple of reasons. The first reason is that it only entitles them to gov't benefits
Here are also potential benefits from the Government from wikipedia.
Titan, I noticed this in Wikipedia,
Chickpea, Wainwright has been wrong these 5 years in a row now, and Selvaraju has 35% success rating with an average return of -7.5%. I have more confidence in the DD of yours', ahabs', hchlaughs', Twizs', Titans', Lazers' and TJ's--indivually--And as a group I think all of you guys have been doing an amazing job on this board on multiple levels.
As for me, I'll be keeping watch right here thank you very much.
FDA OKs Merck's Keytruda combo for fist-line lung cancer
May 12, 2017 9:22 AM ET|About: Merck & Co Inc. (MRK)|By: Douglas W. House, SA News Editor
The FDA approves the use of Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab), in combination with Eli Lilly's Alimta (pemetrexed) and the chemo agent carboplatin, for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 status.
The data supporting the application was generated in the KEYNOTE-021 study. This is the seventh regulatory approval in the U.S. for the PD-L1 inhibitor.
That is a right-on statement Titan
Hschlauch, Cut it out – – you're scaring me! I was actually wondering if it had anything to do with trumps tax plan that might affect the taxation on medical devices. That would disappear under his plan, which would make them more marketable. I know that has nothing to do with marketing up Keytruda for the trial, nor does it explain the markets intrest in competitor Ziopharm.
Chickpea, I'll bet BMS is informed and will be watching. I was wondering if BMS patients respond well here, that BMS would be able to skip right to a P3 trial?
Thou art here, Ahab! Haven't sold a thing and I am underwater – – I'm just waiting for the FDA results on the registration trial and/or anything newsworthy worth talking about, such as where they're going to get their PD-1 from?
You must've missed my post back on April 3 to you – – I was specifically saying that to you to let you know I'm still around, but I've lost interest in the smalltalk after all these years of waiting for it. But I do appreciate you calling me out and will try to show up more often and be an encouragement rather than a down-in-the-mouther ;o)
Just waitin' for that day HC...
Thanks for the response hschlauch, I'm getting nervous in this immunotherapy race.
Interesting hschlauch, that's quit a roadside bomb you just dropped, what's your commentary on how, apparently, ONCS has once again fallen behind developmental advancements (which has always been their weakness).
I'm a just Awaitin'
Yeah Titan, me too. I'm figuring selling on the news since OncoSec still has no Big Pharma validation--and that is what drags on the PPS.
That's right-on Chick!
OncoSec On Watch Before Upcoming Catalyst
Feb. 15, 2017 2:06 PM•ONCS. Seeking Alpha
By Kyle Dennis
Summary
OncoSec has an important upcoming catalyst next week.
The company is working to address anti PD-1 non-responders with its electropulse technology.
If successful, this could open up a large market.
OncoSec Medical (NASDAQ:ONCS) has an important upcoming catalyst. On February 23, it will present new clinical data on ImmunoPulse IL-12, its lead program focused on oncology, at the upcoming 2017 American Association for Cancer Research & Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium.
The presentation, titled Immune monitoring outcomes of patients with stage III/IV melanoma treated with a combination of pembrolizumab and intratumoral plasmid interleukin 12 (pIL-12), will give investors a critical glimpse of the effectiveness of ONCS' electropulse therapy in combination with Keytruda (pembrolizumab), a well-known anti PD-1 inhibitor in one of the most difficult to treat cancers, late stage melanoma.
The treatment methodology goes like this - for years, a long list of companies related to OncoSec have been experimenting on sending small, localized electric pulses to target cells, which apparently become more conducive to receiving therapy as a result. It is well-known that while anti PD-1 inhibitors can be very effective, a large cohort of patients do not respond to these inhibitors. OncoSec claims that its technology, combined with one of these PD-1 inhibitors, can make tumor cells more amenable to anti PD-1 therapy, opening up a huge untapped market for anti PD-1 drugmakers. The pIL-12 EP technology "can drive tumor infiltrating lymphocytes (TILs) and stimulate anti-cancer immune activity."
To prove its point, ONCS has taken up one of the most difficult to treat cancers, late stage melanoma, and in a phase 2 trial, is experimenting with a combination of its electropulse therapy and Keytruda. This is the trial whose results will be out on February 23. As you can imagine, a lot is riding on those results for a beaten down stock like ONCS.
In a previous stage of the trial, OMS-100, overall response rate of 31% and durable clinical response of 48% were observed. 50% of patients also had distant lesion regression, meaning that the immune system was now trained to attack tumors located at a distance from actual treatment area. It is important to note that these patients in a parallel combination treatment were originally non-responders to anti PD-1 treatment, meaning that an entirely new market may open up if ONCS were to be successful. According to company presentation, there's a large market for non-responding patients. :
Oncosec's financial position is quite critical right now. With a market cap of barely $25mn, it has a cash reserve of $25mn as well, basically making it trade at cash. That gives an idea of the (lack of) investor confidence in the stock - the market basically things the company is just worth the cash in hand, and has no enterprise value at all (debt stood at $3mn last quarter).
The company also has a high burn rate of $25M also. I would not think dilution is on the table right now, but it could be an issue in a year. Risks also include negative trial data.
Bottomline for ONCS, it may be a good stock to take position in before an important near-term catalyst which looks to be positive.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
I think that's a very fair assessment Titan.
I'd like your take TJ on any of my points, or do you see it as Titan does?
Am I being a "Debbie Downer" here guys?
Titan, I think your missing my point and reacting like mama bear. The shift in science that is rendering the non-enhanced IL-12 as a mono-therapy is a result of the good work ONCS is accomplishing. That also means, however, that the science is going, at some to in the future, find itself on the shelf; just as enhanced IL-12 will be absorbed into the developing molecular combinations that are already anticipated to outperform Enhanced IL-12.
Also, I realize ONCS is the ONLY company targeting non-responders. However, that population can be impacted positively simply by developing improved combo trials. Immunotherapy is not sitting still while ONCS is trying to increase its competitive edge to non-responders. Increased efficacy is about reaching more people and reaches the non-responder population. Notice the registration trial is not going after just those known to be non-responders but is inclusive to all PD-1 patients.
What I'm trying to say is that this is a horse race. Keytruda is in the lead while ONCS is in it's draft, while making constant changes and additions and all this shifting in the saddle is causing a slowdown despite what you are saying. I already know from the I&A conference that their future is in the molecule cocktail that is in it's infancy at present but will become their lead platform in 2018 when reaches human trials. And when that happens, the present ImmunoPulse platform will (as it should) take the back seat. That then begins a whole new time frame to market. And say what you will about partnership/buyout, it has to have validity of P3 trial data--and I no longer think the present form of ImmunoPulse P3 registration trial will sparkle in the light of the burgeoning new molecule cocktail.
ONCS has this new molecule in the background just like they had IL-12 in the background in mouse trials to their front runner, Beolmycin--and where is that know.
Don't get me wrong. It's because OncoSec's hard work is getting it right which leads to the opportunity to more work. Unfortunately for us, I think, this means the finish line is further away that we thought. I just don't have an idea of when that it.
Hschlauch, I went back to Dr. Jean Campbell's discussion on this at the I&A meeting and this is my take away of what they are trying to accomplish:
Proprietary polycistronic Expression Cassette (The New Molecule combination with IL-12.
First, they have enhanced IL-12. Dr. Jean Campbell demonstrated at the I&A Day how they have significantly improved IL-12 in the reduction of the tumor and increase of survivability in mouse model over non-enhanced IL-12 (They seem to be keeping how they accomplished that under their hats).
Then, in conjunction with the enhanced IL-12, they are looking to nail down the specifics of antigens to added to the IL-12 cocktail in the pre-clinicals being conducted as we speak, in order to gain specific dosing regimens with the use of the TRACE tech.
This data is on target for Summer of 2017 for Investigation New Drug application, with Human trials beginning in 2018.
Do you See where this is going?
IL-12 isn't yielding the results it had hoped in the combo trial and is not attracting anyone--But other potential pre-clinical collaborations, ie. Keven Hollevoet at Univ. of Leuven --Emphasis on PRE-CLINICAL. Here's my take--and HC this goes to your ? about all the shorting of the stock.
First NeoPulse gave way to ImmunoPulse.
Then ImmunoPulse gave way to Keytruda.
Now ImmunoPulse + Keytruda is going to give way to Enhanced IL-12 + cocktail of antigens (yet to be determined) + PD-1 (and others) combo trials beginning in 2018. I believe they have already rendered IL-12 Obsolete, but are going through with the registration trial in the meantime, should there be problems with E+IL-12+antigen cassette in human trials.
I think we are watching another scientific shift for ONCS that has them scrambling to keep from becoming irrelevant, since these "new human trials" are not going to begin until "SOMETIME" in 2018 -- which, incidentally, is going to significantly prolong ImmunoPulse from reaching Marketability.
Damn, I getting tired of waiting :o(
I think it's a little early to say they're struggling with recruitment. That has not been PD's report – – they were actually on track to meet their total number of patients for the combination trial. My understanding of the delay is that it has more to do with FDA application for accelerated approval in combination with a re-designing of the phase 2B trial into a registration trial to include different evaluative data points and patient inclusions. In fact, if they are able to include patients other than just those predicted to be non-responders, then although the trial size might be as many as 140 to 180 patients, they should be able to fill that quota quite easily in a global setting.
When I heard that they had shut down the trial in December I figured a 4 to 6 month retooling of the trial. Especially when I heard them say it's going to be conducted in a global setting – not just a US based trial.
Good morning HC, if I were to look at this from a critical standpoint, I think there are a number of reasons why people are selling:
The first is that OS, has had to repeatedly retool itself every step of the way at key junctures where they may have been partnered with or bought out – – but only to find out they have to play catch-up with the science with new breakthroughs in the science and make the necessary adjustments while also demonstrating updated results to those adjustments. We're at that point with Merck in this combination trial.
Second, the days of pumping up the PPS with articles describing potential just doesn't get it anymore! And this is become extremely discouraging for the traders, both long and short, not to mention us retail investors and to include not being able to hold onto institutional investors. All OS programs are in the experimental stage – – from the trace technology to the combo, to the dilution for funds, the speculative new combination molecule that they are developing – – the risk now has become extremely high.
And lastly, something I've been concerned about is the desirability of medical devices appeal to big Pharma and they're having to assume the cost of production and distribution and maintenance – – I've seen this as a liability to uncle sack from the get go especially with the taxation on medical devices in particular.
I say all this with the potential of the science not withstanding – – that puts even more pressure on the outcome of this singular combination trial with Keytruda. I think at this point it's going to have to be nothing short of spectacular in its results to gain even partnership appeal, let alone a buyout.
I'm still all in and underwater, and I've been growing increasingly frustrated with the process and the difficulty of waiting for it. This post may be affected by my seasonal affect disorder but these are some of my sincere thoughts as I think critically about this stock and this science.
From the "Corporate Milestones of 2017"
Yes, are you saying it's only stock options as opposed to a being better if it were purchasing stocks straight up?
Good morning TJ, what is your meaning to the stock options comment?