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I go with my gut feelings and right now my gut is saying this:
Oncosec is choosing this type of trial design because if they do get 1 response out of the first three patients, 33% ORR than right away that would hold alot of weight with a FDA decision to fast-track this
and get us to market faster.
That clearly seems to be Oncosec's goal with going after the non-responder population.
They intend on clearing this hurdle or not right at the start I think. Much more risk but maybe worth it.
Do or die time.
From what I can gather about the Simon 2 stage trial design is this:
Patients do not proceed on to stage 2 unless they have a response in stage 1.
If there is no response in stage 1 the trial would be terminated. So this is all or nothing right off the bat based on the first 3 patients enrolled. So this is a little scary if say out of 9 patients, the last three patients responded instead of the first 3.
This leaves me to believe that Oncosec has 100% confidence they can get a response from even 1 out of the first 3 patients based on current data.
Titan, this made me a little queezy when Gargosky explained the design for the registration trial. She said it would be a "Simon" trial and enroll 3 Patients at a time. Immediately I was thinking how this may cause continuous trial delays if patients take longer to have a response. I think I will listen to the webcast again later today to try to gain more clarity on this. Wondering if they were required to follow this type of design or what may be the reasoning. Good question for IR because the webcast question and answer session did not address this, maybe because it was not expected.
As Oncosec enrolls the first 3 patients we just need to see a PR in one patient to hit the 33% and continue to enroll the next 3 patients and so on. So we need to see a response in 16 of 48 total patients. I wonder if they could get early approval if they continue to hit the 33% response rate at interval data releases? I think we have a pretty good shot at hitting the 33% ORR.
Oncosec enjoys a better cash position than Heat. If Heat does a cash raise soon I would be they will be forking over some cash to Oncosec. Start of a longer term partnership with money.
What is your take on this info Titan?
This sounds like Heat Biologics will likely be one of our TAP license deals.
I would agree Titan. The fact that he did not rip Oncosec to pieces was a very good nod to the company and the prospects we have. He did a comparison with Ziop a while ago and favored Oncosec results to Ziop's. Our market cap compared to Ziop is way undervalued. AF articles move markets just like Cramer, people trade or invest on their words daily. I am staying long Oncosec no matter what anybody says.
Since Asco data release we have been higher up on peoples radar. Adam Feuerstein writeup on The Street the other day didn't hurt either.
Looking over the swimmers plot from clinical data of the 9 previously failed pd-1 patients in Oncosecs current phase II combo study I am wondering if the 6 patients that did not have any response may have dropped out of the study too soon. The one CR happened at 9 months. The two PR patients had response at 6 and 12 months. It really may take more than 3 months for most patients to show a response.
My bad, I meant to say 2 dollars by monday close.
This is why Oncosec is laser focused on the failed anti-pd1 population.....there is no approved treatment to rescue these people with a death sentence. Oncosec is additionaly fortunate to have an excellent safety profile on top of intriguing response rates to date.
Punit has compared Oncosec's therapy to Amgen's t-vec on numerous occasions, but they use a virus instead of electroporation which has a much better safety profile.
That is why within the next year this stock will either be .50 or $15 based on the data (pure and simple). Place your bets. I am hopefull for positive results.
2 other patients from the 9 patient subset of anti-pd1 failures were partial responders. These partial responders may go on to be complete responders with further treatments. The next round of data updates will be interesting to see how this plays out. So far this is enough to warrant proceeding with the registration trial. 3 patients will be enrolled in the registration trial at a time to validate any response and then additional 3 patients will be enrolled and so on until fully enrolled. So with this type of enrollment we will see fairly soon if the trial will proceed based on only 3 patients.
I think we hit 2 bucks today.
Adam F. likes to break bio stocks so any positive remarks should be very welcome here. He admits excitement in the one complete response patient of the 9 previously failed anti-pd1 patients. Looking ahead to the registration trial if we get 1 or 2 CR and mostly PR for a 30% ORR out of 48 patients we are going to market with this therapy because their is no other choice for this patient population. Good times ahead!
Conference webcast sounded good. Looks like Oncosec is 100% focused on starting the registration trial. They will enroll 3 patients at a time and report data on a rolling basis. If they have any response from the first 3 patients they will enroll the next 3 patients and so on. So we are looking at some data readout by mid-year. They have reaffirmed that they intend to start the trial with a drug supply partnership so this will be the next news to look for very soon. They also mention maybe stopping the current combo-trial enrollments to focus all attention on the Registration Trial.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
The potential for Merck would be hard to pass up. Does anybody really think they would let somebody like Bristol Myers step on their toes here. Not likely. That is why Merck agreed to the combo trial in the first place. Can't wait for the KOL meeting tomorrow.
Doesn't really matter how many they issue anyway. Just means Oncosec will get to market sooner on their already positive results. That is a win in my book.
When Oncosec announces the drug supply partnership with Merck which may come a early as tomorrow that would probably equate to around a 10 million dollar crackerjack toy prize. I think that would surely give our share price a boost.
Share price is being depressed intentionally to rob people of their shares while we are on the brink of blowing up here. Holding tight for sure!
Do you have statistics on that assumption? That would be important information if any body has some insight into this.
Fast Track designation is very Bullish!
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Maybe tomorrow we score a run or two. One of these days they will surprise with the homerun.
Get your peanuts here folks for cheap because pretty soon these shares won't be going for peanuts. Love a good ball game and Oncosec is swinging for the bleachers!
Bulls will be back in control of this soon. Fast Track designation is a big leap of faith from the FDA on recent Oncosec positive news.
Starting to get our ducks lined up in a row here! KOL meeting Tomorrow should be informative.
Lasers, do you know to date what have been the best combo therapy results with keytruda for melanoma? It would be nice to see some comparisons to Oncosec if there are any. How do we compare to t-vec combo if you have any insight into that?
Hopefully Merck will be less mute in the near future with respect to Oncosec... and then the point will be moot.
Merck is definitely interested in what Oncosec is doing. They would not have bothered to let Oncosec use Keytruda in the UCSF combo trial if that were the case. We will just have to wait and see what clarity we get from the KOL meeting next week.
I would think that Merck would be interested in increasing response rates to 48% if this included keytruda responders and also keytruda non-responders (broader patient base). I absolutely think going after the non-responder population is great but I also think that enhancing responders overall outcomes should not be discarded either. If I were on Keytruda and a doctor told me I am likely to have a 48% response with the addition of ep-il12 to my therapy as opposed to keytruda monotherapy at around 20-30% response rate I would opt for the combo therapy.
If Merck is only interested in pursuing the non-responder population with Oncosec then the point is mute right now.
I think Tuesday we get more clarity on this issue. I was thinking the same thing last November when they changed the protocol of the current trial with the intent of targeting only 100% anti-pd-1 failures in a registration trial. This is not a one size fits all therapy. I wonder if they would readjust the criteria for the registration trial based on this latest data? Couldn't they run 2 registration trials simultaneously to target the different patient populations?
Titan, you are probably right. I, like everybody else here just wants the validation we need sooner rather than later. If Oncosec can produce 30-40% response rates in a registration trial targeting 100% failed anti-pd-1 patients than it is a no-brainer that Oncosec melanoma combo therapy is going to market. My gut feeling tells me that Punit is going to focus completely on licensing. If Merck does fund the drug supply and make some sort of exclusive deal with Oncosec I believe any money would be used to fund future clinical trial relating to the multi-gene candidate to start in 2018. Longer term that could be a major market cap jump for Oncosec. I really believe Punit wants to grow this company not sell it. As much as I would like to see a huge share price spike right now I still believe in the science and direction Oncosec is heading even if the share price doesn't reflect it yet. I am a long term holder here no matter how long it takes. Immunotherapy/combo therapy is the future of cancer treatment and Oncosec will be a relevant force I believe.
That is the news we need next tuesday. After good reported data yesterday we need this follow through badly to gain market support. I believe we get it and Punit realizes this is critical and has said we are going into the registration trial with a drug supply partnership. Oncosec Game Face on next Tuesday! Let's get this done and fast.
Hey Titan. I believe they will begin the registration trial on the basis of current data. It is a good thing that the subset of 9 failed anti-pd-1 patients (33%) are showing a response or we might have a problem. The change in trial protocol last fall really shook things up so there is alot of hope and fingers crossed that more positive data comes out of that protocol change. Any more evidence to show absolute anti-pd-1 failures are responding to treatment will go a long way with market confidence heading into the registration trial...meaning institutional investment, partnership dollars etc. We don't need more dilution here, we need confidence and money. Merck is it. They give us the cash nod and we are solid gold. It is tough to see them spread the wealth to other companies and we have been waiting on Oncosec to get their due respect.
Oncosec Clinical Data Plot in their publication today shows that of the 9 patients that had previous checkpoint blockade:
2 patients were partial responders and 1 patient had a complete response by the 9th month of treatment. The 1 partial responder is only at the 6 month stage so may become a complete responder with further treatments. The 1 partial responder at 12 months seems to be responding slower than the other responders. So this could mean that patients that do respond to the combo therapy are slowly becoming complete responders by the one year mark.
The 2 partial responders are continuing on so the next data readout will be critical.
It is amazing that Oncosec is getting a response in patients that have 100% failure to pd-1 monotherapy.
This is big and the market doesn't care today. So we need more patient data going forward which I believe we will get later on in this trial which will be enough positive data to get the green light for the registration trial.
Also one other thing to note here is that 9 patients is a very small set of patients to gauge by so 1 more responder here is the difference between 33% and 44% so if you applied that number to say 1000 people if the percentages hold up in a larger trial of non-responders you are talking about a lot of people who now have a second chance with combo therapy. 300 or 400 people for every 1000 people suffering melanoma cancer could be treated. I think the markets are easily disappointed and expecting a grand slam home run. Oncosec is on the right track though in my opinion.
That would be my guess. Because the 9 patients represent the pd-1 failure population and the rest of the trial patients are predicted non-responders from the bio-marker assay. The rest of the patients to be enrolled in this trial will also be failed pd-1 patients so this will be important data reported probably at the next Asco conference in June if they have data ready. The registration trial they are gearing up to do rides on this data because the registration trial will only enroll previously failed pd-1 patients.