RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:ATM I agree completely and as you've seen me say in the past, I think it's hard not to believe that the taxol part of the equation Should work based on history and well known effects on most tumors provided it can get in there and not hit resistance. I also like that it will have even higher margins once commercialized. I was just stating that in the odd occurrence for some bizarre reason that it's the cytotoxic agent that isn't that effective (I certainly don't expect to see that), you might still be able to prove the peptide did it's thing in which case you look for something else. In other words, the program isnt a total failure and the hard part could be proven even if efficacy is no greater than control group. I doubt that will happen, but just wanted to point out there are 2 elements to prove up and each is important in its own right.
I am all for keeping it simple, get the darn license to sell, start selling and then use your profits to explore all the other ways to use this -other peptides, other toxins, etc. I wouldn't waste a penny or any resources beyond getting TH1902 over the hump. It's too important for the future of the company and for out investment returns. Once done, uncage the laboratory scientists.
qwerty22 wrote:
"meh" "good enough"
You're both doing a dis-service to the lead drug because you have this notion that newer and stronger is what is required. It isn't. There has to be a reason that docetaxel is still given to large numbers of patients, why it is still the backbone in some indications.
Wino if ThP01 is doing its job, that's to say all the things it's meant to do like get in the cell, break apart, bypass resistance then docetaxel will do it's jobs in some of the indications, it will be effective in breast cancer and others. That is the immediate goal.
Eventually in the very long term, after the first approval, then sure you want to maximize the opportunity of the tech by trying to match every indication that expresses Sortilin with the best possble variant of the drug but that is way off in the future. There is no need to think what they are doing now is in anyway compromised because that might be your ultimate goal.
Getting first approval is a separate issue to maximizing the possibilities of the tech, it doesn't really matter that they appear to have different solutions. They are separate issues think of them as that.
It's a little like Jfm's rush to optimize efficacy. We know the fda want them to explore how broadly applicable this tech is, there are good reasons to do that, but it inevitably means compromising on optimizing efficacy (that one reason why I say we don't need to be seeing very strong efficacy numbers atm, it will be great if we get them but it's not the goal atm). Jfm keeps pointing out they might be compromising efficacy (and that is true) without understanding that is not the exact goal of this first trial.
You're both making the same mistake on this point. Don't judge th1902 for its ability to be optimal in every indication, judge whether it's fit for purpose for getting the first approval. I think a taxol drug has many advantages when it comes to that job.
jfm1330 wrote: Their idea at this point is that docetaxel is a good enough drug to show some efficacy in some patients amonf all those that will be treated in phase I overall, hence, good enough to establish the proof of concept. Then, they will analyse the results in phase Ib to understand why it did not work on some patients overexpressing sortilin.
Remember, Marsolais said that they will start using patient derived xenografts (PDX) in mice. So they will be able to take tumor cells from a patient on which TH1902 is not working, graft some of those cells in many mice, and test it with other PDCs, like TH2101, or other they have that we did not hear about yet. Let's say TH1902 is also not working on PDX, but that TH2101 is. It would clearly show that TH19P01 is not the problem, but docetaxel is. They could also identify some genetic mutation leading to docetaxel resistance.
If they can establish the proof of concept, it will only be the beginning.
https://en.wikipedia.org/wiki/Patient_derived_xenograft
Wino115 wrote: There's really 2 elements to it as well. The efficacy and POC of just the peptide THP01 and the toxin. If the peptide does what it is designed to do, they can still use other toxins that are more effective than taxol if taxol was "meh".
qwerty22 wrote:
.... and btw it's really hard to know what "fails" means around the Ph1 part 1 data. There are very few scenarios I would label an outright "fail" and the time for some of them has already passed. We might get weak efficacy indicators but this cohort is far from optimized for efficacy, the program can certainly handle weak efficacy numbers at this point.
qwerty22 wrote:
Soleus will sell if cancer fails, they won't be the only ones.
jfm1330 wrote: If this reflects what the market is really thinking, this is great. It would mean a weak drop in case of total failure in oncology, but a huge rise in case of really excellent results. You can buy the oncology potential for free. At the same time, it shows how these analysts are useless.
jeffm34 wrote: Research capital just put a $5 target on TH.
$2.62 for their commercial sales and $2.31 for NASH. $0 for oncology.