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"yes he is for real alright. Just ask the SEC LOL" excuse me I don't get sarcasm that well. The market is reacting , have you noticed the volume lately?
that he was allowed to make millions on Celator in 2016 after buying days prior to P3 announcement and the acquisition 2 months later. So why do you say he is fake when the Sec does not think the same.
yes, and the crazy thing about it is the sec allowed for him to continue investing with his private family fund, Point72. So basically he was not proven guilty. How many millions he made with that fund buying Celator days prior to P3 results and an acquisition months later.
The Sec will be lifting the ban in January 2018http://www.businessinsider.com/steve-cohen-hedge-fund-said-to-send-pitch-documents-to-investors-2017-9 and he will be coming back with a lot of money to invest. He just picked little Oncosec as his future hidden gem, just like he did with Celator
You're saying Jason McCarthy is not a real analyst? he was present at Oncosec's last conference call. https://www.tipranks.com/analysts/jason-mccarthy
Technological disruption it will be, since combinations of immunotherapy are the paths to an approach for the fight on a tumor, but a vehicle is needed for helping with synergetic efficacy and lowering the toxicity and disruption of the immune system. Electroporation of IL-12 is taking care of that.
Reading the first report of electroporation-mediated IL-12 gene therapy done back in 2001, signs of the cytokine's importance was already proven by the eradication of established murine tumors and their metastases, leading to the generation of tumor-specific immunological memory. However, in the first clinical trial, IL-12 protein therapy resulted in the death of 2 patients and led to severe toxic effects in 15 others. http://cancerres.aacrjournals.org/content/61/3/1005
Sixteen years later Oncosec shows results of electroporation IL-12 in a combination therapy with Keytruda, the most important immunotherapy to date. The study yielded a 50% best overall response rate at 24 weeks, with 42.9% of the cohort reaching RECIST v1.1 response. The combination resulted in 41% of patients who were diagnosed as non-responders becoming complete responders, 9% had a partial response, and 9% had stable disease. This accounted for a total disease control rate of 59%. The serious adverse event rate in the combination study was 8.7% with no life-threatening or grade 4 adverse events. That's pretty amazing when compared to other present studies which are not utilizing an assay for assessing the non responders like Oncosec is doing.
I found this article that was published days after Oncosec's results got released. Researchers identify a molecule p40 monomer which is a member of IL-12 group of proteins that facilitate communication between cells that helps cancer stay alive.
"The team saw that when p40 levels dropped, cancer cells died (though lung cancer cells were not affected), and prostate tumors treated with the MAB in the corroborating mouse model shrank significantly. Levels of interferon-gamma (IFN-gamma) protein, which is capable of killing tumor cells on its own, also rose sharply."
https://medicalxpress.com/news/2017-10-molecule-cancer-alive-antibody-therapy.html
This is very good news for Oncosec as it shines a light on the importance of IL-12 cytokine and helps to show why they are on the correct path. The scientist are hoping to bringing p40 to clinical trials but it will take a few years for that. In the mean time Oncosec has fast track designation and will look to qualify for expedited FDA review, and a rolling Biologics License Application (BLA)
a massive new hedge fund soon to be started, there is more money to be invested into Oncosec and it will come before mid 2018.
http://www.businessinsider.com/steve-cohen-hedge-fund-said-to-send-pitch-documents-to-investors-2017-9
we both agree, and the best part is that in January of 2018, he will be allowed to manage hedge funds again, and he will most likely invest more money on Oncosec before all is said and done. Pisces results.
I agree with you, however, that 30% most likely happened due to the inside information the company was getting. He has not been able to attain those types of annual returns since. Last year he reported a position of CPXX the same day they released P3 data. Three months later the company got sold and share price had moved from around $1.50 to $30, he did really well on that investment.
When you don't like a company everything they do seems negative. Steve Cohen has been associated with inside information more than once, but that does not change whatever the company he is buying stocks in is doing. An example is Celator Pharmaceuticals (CPXX) in which he took a position a couple of days before P3 results came out and three months later the company got purchased. https://seekingalpha.com/news/3168045-steve-cohen-made-big-bet-celator-right-soared-400-percent
Celator went from like around $1.50 to $30, and not because of Steve Cohen but because of their success. Cohen just happened to use that information to his advantage.
How is that bad for Oncosec if the same happens?
I see you saw my post, just wanted to add that in cancer care, durable response has to do with a long-lasting positive reaction to tumor therapy, usually lasting at least a year. On June 2,2017 Merck presented findings to a study for advanced melanoma showing durable responses with Keytruda after treatment follow up of nearly three years:
"In the longer-term findings to be presented, treatment with KEYTRUDA was associated with a 30 percent improvement in survival: 50 percent of patients in the KEYTRUDA group (based on a pooled analysis of the two doses studied: 10 mg/kg every two weeks or 10 mg/kg every three weeks; n=556) were alive nearly three years (33.9 months) after starting treatment with KEYTRUDA, compared to 39 percent of patients in the ipilimumab group (n=278) (HR: 0.70 [95% CI, 0.58-0.86]). In addition, KEYTRUDA nearly doubled the rate of progression-free survival (PFS) at 33.9 months: 31 percent of patients in the KEYTRUDA group were alive and their disease had not progressed, compared to 14 percent of patients in the ipilimumab group."
you know that is not how it works, but you also don't know what the future holds. But what we both can agree on is that it looks promising.
yes, number of patients are small, but you are missing the big picture, which is the set patients are non-responders, and there was a huge difference when combined with Keytruda {50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved RECIST v1.1 BORR).} in comparison to the monotherapy. That is for sure encouraging for Merck. But the best part is the favorable side effects,which I am guessing they are better than Keytruda's side effects without the use of electroporation
Hey Dr_Low are those results good enough for Merck? do you remember the assay being used to determine the non-responders? if not let me know, I can post that information here to refresh the memory
and what would you change about its recent study to make it into real science? or are you saying the results have been a waste of time and the FDA is mistaken and don't have real scientist to recommend a fast track.
I corrected it on my last post, but thanks for clarifying that. I got confused there for a moment.
Low, you are correct, it is 187 applied and 131 were accepted for fast track. What I read was fast track for break through designation.
I do agree with you, however, this is something that I have noticed in 2016, hopefully things will change in the bio market. Today IBB broke $300 for the first time since December 2015. Maybe true valuation will start to get fixed once banks start lending money again this year.
do any of those companies have revenue?
divide $25 million by total amount of outstanding shares and you would get $1.31 a share. I have noticed in the past year many companies are being valued according to the amount of money they have on hand to work with. Keep in mind, Oncosec does not have a product to create money, which makes it more difficult to attain the proper value. They will, but with more time.
previous to Oncosec receiving their FDA Breakthrough Therapy Designation, 35 fast tracks were given to companies from Jan.6 2016 to Jan.31 2017. The best thing about a fast track to an investor is that it equates to more future revenue that can be made from the product from the time saved in the study. They will most likely create a study with a much larger population that includes both non-responders to anti-PD-1 and PD-L1 therapies. They will need some extra funds for this, as well as the help from Merck for additional Keytruda. It would seem that it is to their best interest to start paying attention to the study if results continue positive.
In the mean time, the market will value the shares according to the amount of cash at hand, which means at present time it is slightly over valued. They will need money to allow the share price to rise and with a fast track it should not be difficult to attain.
Keeping it on topic.
Titan, thanks for the information. Like you said, Punit mentioned the melanoma combo may not see a licensing deal until 2018 (contingent on data of course) but I think the course has changed with the fast track acceptance that is mentioned on page 40. It will help to establish a partner that can help with further costs, since it is expected to be with a much larger population, by cutting valuable time that's needed to achieve FDA approval.
How about now, will a fast track help with product collaboration deal or, according to you, will electroporation still be considered an odd equipment?
That analysis came out on Jan.16, why would you change the date? https://www.thecerbatgem.com/2017/01/16/gevo-inc-gevo-upgraded-to-buy-by-zacks-investment-research.html so it did not increase price today. However, the day after, the price did go to $4.98 after EPA news was released and sold off right after. I think that $4.25 price target is still there.
Thanks for all the information. Hopefully the TNBC is on schedule, unless they added more patients to it (up to 25). I agree, good things are ahead in the coming months for Oncosec. It has been quiet in volume but at the same time any significant news will make the price move fast.
It will soon look to start testing new highs, maybe from $1.93-$1.97, and in October the Phase1 study for Evaluation of Pharmacodynamic effects of IT-pIL12-EP in patients with TNBC concludes. Dr. Melinda Telli might be speaking on the subject on Nov.4, when she will be giving an update in Triple Negative Breast Cancer.
http://bcconnections.org/events/conference/
“He said it was impossible to tell whether the immunotherapy could have had some delayed effect and worked synergistically with the chemotherapy. Clinical trials are now trying to resolve that question.”
I have read abstracts in which immunotherapy has responded better when combined with radiation or chemotherapy, like in the case of Jimmy Carter. A strong reason of why I believe that electroporation of IL-12 can eventually replace both. Unlike radiation, electric pulses done with EP IL-12 allows for the immunotherapy to actually enter into the immune system through the cells, allowing for IL-12 to enhanced functional response that is demonstrated by IFN-y production and killing of target cells, a job normally done with chemotherapy while risking the targeting of good cells.
Oncosec is using a local injection–global effect model as their therapy, where electroporation of IL-12 is a nonviral therapy that has already shown interesting single-agent results when tested on its own, and is now studied in combination with anti PD-1. The trial is for patients that normally would not respond to anti PD-1 due to their low TIL s. It can be deduced from the patient’s complete response of the target lesion, shown in the PET imaging after only 2 cycles of IL-12 and a fourth cycle of pembrolizumab whith no other sites of disease by the fifth cycle of treatment, that the electroporation of the interleukin is helping to raise those TILs by stimulating the production of interferon gamma (IFN-y) resulting in the synergizing of anti PD-1.
PET imaging is a method of assessing the bio distribution of new biological compounds of therapeutic interest rapidly and is of great importance in the study. I mentioned previously the use of a tracer in the PET imaging for oncology and in this case, IL-12 acts as an immunoPET tracer to image PD-1 expressing TILs. One can conclude from those results that non-responders are responding.
Looking more into the subject, I found an interesting abstract that helped me understand the results and what Oncosec most likely accomplished.
http://pubs.acs.org/doi/abs/10.1021/acs.bioconjchem.5b00318?journalCode=bcches
Seems it is getting into position for the start of August.
not a problem thanks, I edited just a few seconds ago to make it more clearer, and I hope that results continue this good.
I have been following other companies the past couple of months, one that has my attention is setting itself up for recovery with good products in the market and restructuring on the way. Pernix Therapeutics.
TitanV, those results look very promising, with the addition of one patient exhibiting locoregional shrinkage of distant untreated melanoma nodules. It is incredible that the 62yr old experienced a complete clinical resolution of all treated lesions after only 1 cycle of IL-12 and 2 cycles of pembrolizumab.
It is also encouraging that the one 69-year-old female patient after 2 cycles of IL-12 and 4 cycles of pembrolizumab experienced a positron emission tomography (PET)/computed tomography (CT). It confirmed complete response of the target lesion, and had no other sites of disease by the fifth cycle of treatment. I am not sure if it was done without the use of a tracer, but I am thinking that’s what they meant.
A positron emission tomography (PET) scan is an imaging test that helps reveal how tissues and organs are functioning. A PET scan uses a radioactive drug (tracer) to show this activity. The tracer may be injected, swallowed or inhaled, depending on which organ or tissue is being studied by the PET scan. The tracer collects in areas of the body that have higher levels of chemical activity, which often correspond to areas of disease. On a PET scan, these areas show up as bright spots. It seems the reaction of IL-12 with anti PD-1 is allowing those areas to show without the use of radiation that is found in the tracer. PET scanning with the tracer fluorine-fluorodeoxyglucose (FDG) is widely used in clinical oncology. A typical dose of FDG used in an oncological scan has an effective radiation dose of 14 mSv.
Most tissues cannot remove the phosphate added with the FDG. This means that FDG is trapped in any cell that takes it up, until it decays. This results in intense radiolabeling of tissues with high glucose uptake, such as the brain, the liver, and most cancers. As a result, FDG-PET can be used for diagnosis, staging, and monitoring treatment of cancers, particularly in Hodgkin's lymphoma, non-Hodgkin lymphoma, and lung cancer. That would be great for doctors if they can look for progress without the need of radiation, especially keeping in mind that patients are non-responders. The more quickly information can be gathered, the higher percentage of survival.
http://www.cancernetwork.com/oncology-journal/review-novel-intralesional-therapies-melanoma-emphasis-potential-combination-approach
Or they can do what you do, or they can buy lower and wait for .25
It has already, many times, like for instance when Zohydro ER got approaved. As a matter of fact, part of the problem might be that because it is an instant release form and contains naltrexone, the person might not feel the effects of the opioid agonist and decide to take another.
That's where the issue comes into play. The FDA wants to approve drugs that do deter over dosing. However, when raising the bar to that standard, where do you begin to determine the approaval of a drug that builds tolerance with time or that if not administered correctly can damage an organ? Let's keep in mind that those types of drugs are normally intended to be prescribed for patients in need of short term or last resort help.
Not until it retest .25
It should be back to .25
I heard different, the concern is that a person might overdose if they do not feel the effect of an IR drug and decide to take more than prescribed. That's an FDA concern and not something that the inventor of the technology would be concerned with when creating the drug.
the price is back to the highs of 2013, what problem was the company dealing with back then?
The Epic Pharma facility has nothing to do with the matter any longer, ever since the acquisition by Humanwell Healthcare Group and PuraCap Pharmaceutical on March 31. On March 17 the FDA had agreed to go into a more detail review with a PDUFA date set for SequestOx and due to the timing of the acquisition, the required changes for manufacturing/marketing sites where probably not made. In addition, PuraCap International was created on March 24, when PuraCap Pharmaceutical acquired two other companies, Blu Pharmaceutical and Blu Caribe which open their market to include oral tablet and capsule dosage forms for both the U.S. and global markets. So there where a lot of changes that took place after the FDA had agreed to the review. In a few minutes we will find out if any of that is what prevented the approval at this time, or if it was labeling. It would be better than a problem with the study.