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My take on Oncosec PPS at this point is that if we get partnership /money after combo results share price will move up. If no partnership/money, then Oncosec will do more equity raises and the share price will stay where it is for an extended period of time until we see revenue.
It sounds like they have developed better control in all aspects of the device so I would think maybe there would be less pain too, even though the pain level in the original device was minimal and quick.
Oncosec really needs to PR every bit of new data. Not sure why this was not PR'ed. Seems like important data to me.
Merck stock up today, momentum is on their side lately. Would love to wake up one morning with exciting news between Merck and Oncosec collaboration expansion....just saying for the hell of it. Being positive here even though the market is in care-less mode.
Oncosec Electroporation device update summary:
- Tissue sensing functionality ensures proper tissue insertion and co-localization.
-? EP parameters adapted in real-time to maximum expression in homogeneous or heterogeneous tissue.
-? Ability to stop EP based on tissue properties.
-? Improves safety of electroporation process.
-? Personalize therapy for each individual tumor.
-? Potentially reduce treatment frequency through durable expression.
Making advancement with the delivery system it seems.
Updated information in Publications section of Oncosec website.
It will be interesting to hear any new Oncosec developments from the 13th International Bioelectrics Symposium today. I would think a PR will come after this.
Merck recently "flipped the script" on Bristol Myers. They need to enhance their advantage in the melanoma race. If the combo results turn out how we think they will, Merck must make a move. Oncosec at 30 mil market cap is just ridiculous.
Commercialization and Registration seem imminent; just a matter of when. Merck would be foolish to not lock this one down with a buyout or investment money.
Some government funding here would be sweet!
Bouncing off the bottom again.
Stoxline.com posting 5 star strong buy on ONCS today. Tight range ready to breakout.
Good combo data results will clear up the doubt with Oncosec....and bring a new wave of Institutional investors. A phase III registration trial will move us up a notch.
Nah, I think the market has this one just about wrong. Word to Bigbird.
Absolutely correct. The market is truly underestimating the potential Oncosec holds.
The FDA accepts for review Merck's (NYSE:MRK) supplemental Biologics License Application (sBLA) seeking approval of the use of KEYTRUDA (pembrolizumab) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, a Breakthrough Therapy designation. The agency's action date (PDUFA) is December 24.
The Keytruda label expansions will continue.
Another note about T-Vec. The combination of T-Vex and Opdivo yielded in the 50-60% overall response rate.
EP IL12 + Keytruda should at least equal these results.
LOL....i said after a registration trial.
Robert Andtbacka, MD, is a clinical and scientific advisor to Oncosec. Just a reminder to investors here that Dr. Andtbacka is recognized as a leader in intratumoral immunotherapies, and he was pivotal in the approval of Amgen’s oncolytica virus therapy, T-VEC, for melanoma. Amgen forked up 1 Billion dollars for t-vec therapy. There may be many ifs regarding whether or not Oncosec results will hold up to a larger sized trial like the one t-vec did which enrolled over 400 patients. IF the results from our combo trial with Keytruda lead to a larger registration trial that are equal to or better than the t-vec results then a 1 Billion dollar buyout is not a far-fetched outcome at some point......just something to think about. Reading a little bit about Robert Andtbacka leads me to believe he is motivated to bring melanoma therapies up to speed with other cancers.
Spot on the money Titan. What we need is definitive proof of concept here and the proven Bio-Marker assay is a huge step to achieving that goal.
Yup, but EP-IL12 is Oncosec proprietary technology. So big deal if other companies use the Bio-Marker assay. If Oncosec platform shows better results with far less severe side affects than other therapies do it is a win for Oncosec. If EP-IL 12 + PD1 yields better results than Keytruda or Opdivo monotherapy, EP-IL12 + PD1 could be used as a first-line therapy for non-responders. This represents a vastly larger number of cancer patients than the ones who respond to PD1 monotherapy which is only around a 30% response rate.....and there is big bucks down the line to treat these patients who do not respond to monotherapy.
I didn't think we had any proprietary rights to the Bio-Marker test, but we definitely have the rights to use the test....and the test works great to predict non-responders so they do not need to develop any other companion diagnostic test at this point. What is important is that we have this proven test that will select the right people for the planned registration trial. IR seems very confident in proceeding with a registration trial. IR has been very curtious with their responses and I feel that they already know the data is good enough to proceed to the next phase.
Just received a response from IR about Bio-Marker test.
I asked about proprietary rights to the Bio-Marker test for screening patients for the combo trial.
Their response:
"We will not be developing a companion diagnostic in parallel with our commercialization strategy for ImmunoPulse IL-12. The current biomarker assay has proven to be a very strong surrogate for the low-TIL (anti-PD1 resistant) patient population that we are focusing on with ImmunoPulse Il-12.
This was nicely highlighted in the Journal of Clinical Investigation (http://www.jci.org/articles/view/87324) showing that this biomarker assay can accurately predict patients who will and will not respond to checkpoint therapies. The data published provides evidence of the strong predictive value to stratify patients and will be able to robustly identify a combination efficacy signal in our ongoing single-arm trial. Our planned melanoma registration study will be treating patients that fail anti-PD1 therapy.
My take is that they will not owe any royalties or fees for the use of the Bio-Marker test.
I think we are in for more volatility as we head toward the November election. Hillary Clinton's stand on drug pricing last year definitely caused turbulence with biotech and pharma stocks. I think that if Oncosec releases excellent combo study data that will supersede what is going on with the election, hopefully.
Data release at The Society for Melanoma Research Congress in early November looks like a good bet.....or Melanoma Bridge in late November. The data can't come soon enough.
The International Bioelectrics Symposium on the 12th could give us an indication of where Oncosec is headed with the next generation electroporation device.
So far we have evidence from mouse models that they are able to optimize gene electrotransfer and that the new helical needle creates a 3-fold increase in surface area for DNA-tissue interaction. The device will allow the application of intratumoral IL-12 gene immunotherapy to a broad range of deep tissue cancers.
I think the announcement of a new gene candidate and initiation of a phase 1 trial will use this next generation EP device to test the "multi gene" delivery ability Punit spoke of.
Good read about resistant cancer mutations in the body and the growing belief among researchers that combination immunotherapy with a two or three pronged attack betters the chances of wiping out cancer.
http://www.nature.com/news/cancer-therapy-an-evolved-approach-1.19746
September 12th could turn out to be a good day for data release. 2 conferences, same time, same day. Maybe we get Combo data and announcement of new multi-gene candidate on the same day?
No word yet from IR on question about proprietary ownership of Biomarker assay.
Just out of curiosity I emailed IR about what proprietary rights we have to the Biomarker test if any, and if we will owe any licensing fees, royalties, or money assuming we get to market with the combo therapy and are using the Biomarker test for screening. Seems like an important bit of info to provide some clarity on this point. Even if we have no proprietory rights to the Biomarker test and do not have to pay any money to use it, it does the job for us in selecting patients who will respond to the therapy which is the most important thing here.
In 1985 Apple was a 500 million dollar company. Oncosec uplisted to the Nasdaq last year at $5.50 per share and 100 million market cap. I am simply comparing how a small cap company with little support in the market can rise substantially......with the right catalyst such as a groundbreaking product that people either love or need. People loved the iPod and the iPhone. People who are dying of cancer need alternative therapies such as immunotherapy. Oncosec is pioneering a new platform to hopefully augment or replace chemotherapy and radiation. Those have been standards of care for a long time now. Many people are lucky enough to survive their cancers with radiation and chemo but most people do not. Most people at some point will be touched by cancer and either a family member or friend will die from it. I have a friend who recently died from Breast and Brain cancer a few months ago. She was diagnosed a year ago after she had a pain in her side. At 48 years old she is dead. Radiation and chemo could not save her and the side affects were horrible for her. Her last year of life was hell.
So for people like my friend and anybody else who is not lucky enough to respond to the present standards of care which make you sick in all kind of nasty ways before you die, I will keep the faith in Oncosec and their mission to move us into the future of immunotherapy and a better treatment for cancer and hopefully like Aids a manageable disease, not a death sentence.
Any setbacks with CAR-T programs will be positive for Oncosec. Juno had 3 deaths with their CAR-T trial last month. That might be specific to just their company and not other CAR-T companies like Kite....but as quoted by STATNEWS.com last month:
"The fear is that the FDA will take a dim view of the whole CAR-T class, slowing down the progress of each program and forcing companies to delay their expected filings, as Juno already has."
If Oncosec can prove their hypothesis of turning non-responders into responders and make it to market with a viable solution to treating cancer with no adverse side affects ahead of other companies we will be in great shape.
What Punit needs to do is seize the opportunity when it arises. If we get the results we are expecting by years end, he really needs to get the word out on Oncosec and PR the crap out of this. We need articles printed in Forbes, Newsweek, Time magazine. Publicity! Inovio has gotten PR and airtime on tv (MADMONEY). We need some of that to get people interested here.
Nonsense would be more like: "APPLE BUYS ONCOSEC TO CURE IPHONE TOUCH DISEASE WITH ELECTROPORATION". Reality and common sense would be: Oncosec treats 70% of non-responders to PD-1 with Keytruda and EP-IL12 combination therapy with a 75% overall response rate. If the data from the upcoming trial is anywhere near 75% response rate this will not be a sub $2.00 stock anymore....that's the facts JACK!
Apple analogy here is not being so arrogant when Oncosec has the potential to tap into a growing 30 Billion dollar market in the next few years just like Apple taped into the music and smartphone industry at the right moment in time.
Good point and look at Warren Buffett buying IBM while it has been horrible the past few years. If you can see the long term value it just takes time and patience. The market will wake up to Oncosec big time soon. I am absolutely looking at Oncosec as a diamond in the rough and that is what I knew I was investing in. The huge potential is there. Years ago Apple was on the verge of bankruptcy and look where they are now. High risk, high reward......investors need to think outside the box at some point if they want to find a massive winner. Good luck to us all here.
At the moment the market doesn't give a crap about this very positive data. When we post positive pd-1 combo results then the market will give a crap because we will be moving into final stage trial with a proven biomarker test as well. Time to wake this market up and bring on the data!
According to Whalewisdom.com, Ridgeback is sold out since last quarter. Hopefully we get the good news soon to get us away from these short selling hedge funds. Sabby also has reduced holdings again. Vanguard adding slowly is a good sign though. Any day now we should get conference announcements. We are presenting at Rodman and Renshaw event in September but not officially announced yet. Slowly waiting for this turnaround with fingers crossed.
The market was spooked by the S-3 and is completely underestimating Merck's willingness to put more meat in the game here when combo results are announced. We need those combo results ASAP.
Conference announcements for September should be coming soon. Hang in People and we get a move upwards!
TNBC trial is listed as a phase II trial on Oncosec website but on ClinicalTrials.gov it is listed as Phase I trial. Anybody clarify this?
JOURNAL OF CLINICAL ONCOLOGY article from 2015 titled:
IMMUNE CHECKPOINT BLOCKADE IN CANCER THERAPY.
Lots of clinical data in this article.
jco.ascopubs.org/content/early/2015/01/20/JCO.2014.59.4358.full
I especially like this part:
Biomarkers Associated With Disease Outcome
Treatment with immunologic checkpoint blockade would ideally be matched to patients who are most likely to benefit and least likely to experience adverse effects. The efficacy of CTLA-4 and PD-1 blockade also somewhat varies among different tumor types, and better understanding these differences would enhance the efficacy of this treatment modality. At this time, no single immunologic or tumoral characteristic in a patient has been found to solely determine response to an immunotherapeutic agent.
ONCOSEC! WE GOT THIS!
I just received a response from investor relations regarding my question as to whether or not the Biomarker assay was used in the study/data released at AACR earlier this year. Here is their response:
The biomarker assay was not used with patients in the study/data that was presented at the Annual AACR Meeting in April. These patients were enrolled in our Phase II melanoma monotherapy study. After completion of our study, some patients went on to receive anti-PD-1 therapy. Researchers documented and analyzed long-term follow-up data after they received anti-PD-1 treatment.
The biomarker assay is currently being used to select patients for the ongoing Phase II clinical trial evaluating the combination of OncoSec's ImmunoPulse IL-12 and pembrolizumab in melanoma patients. We're using the assay's ability to select patients, who are unlikely to respond to anti-PD-1, and enroll these patients in our Phase II combination trial. Data from this trial is expected to be presented in 2016.
What investors should understand about Merck is that they have become a more cautious company since their troubles with Vioxx. Ken Frazier was instrumental in steering them back from the dead and he is more focused on diversification and long term shareholder value. Immunotherapy is on the radar of all Big Pharma and Oncosec having an extremely safe platform will spark alot of interest when combo trial results are released.....as long as those results are good.....I think they will be great actually.
Absolutely, and good catch on the Algazi information. This is further proof Merck is willing to offer funds towards the research and education in EP-IL12. This is definitely positive info. Wish Oncosec would PR more tidbits like this to spur as much positive sentiment in the company as possible.