Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Part of the challenge for TH

[scarlet1967]

Yes, hopefully no DLTs at 6th or 7th cycle or not at all, one thing which is also important is the overall profile of the drug, tumour chemoresistance (efflux), improved cytotoxic activity, reversal of tumour-induced immunosuppression, prevention of metastasis, impact on vasculogenic mimicry etc. so even with “narrow therapeutic window” one has to presume other beneficial aspects of targeted delivery should add clinical and commercial advantages versus classic chemo.

To me it is quite important factors to consider to understand the benefits of the drug at whatever therapeutic windows.

 

qwerty22 wrote:

Ok I get it now. What you're talking about is therapeutic window. I remember reading that using this 3+3 method is that if you get to the point of 2 of 6 DLTs then drop down to the MTD then what you end up with is a dose where 40-70% of patients experience a grade 3/4 toxicity from treatment with that drug.  If your efficacy dose is at or close to the MTD, that is if you can't drop very much below the MTD before losing efficacy, then you have a very narrow therapeutic window and the overall safety/efficacy profile might not look so great. But if that's in a cancer with no good treatments atm that might look like a viable drug although not super exciting, maybe with not much hope for expansion into other cancers or not much appeal in the clinic to drive revenue. I think you'd have to know the full profile of the drug but a narrow therapeutic window is not an attractive prospect.

I think the point of targeted therapies though is to have a wider therapeutic window than untargeted chemo so hopefully we want to see the drug develop DLT in later doses or maybe even not at all in this dose escalation phase. From my memory they aren't really going much higher than how docetaxel is used now (maybe double the docetaxel equivalence), we may not reach DLTs if things go really well.

 

 

scarlet1967 wrote: I don't think you got my point what I am saying is approval based on full spectrum of planned patients for all phases  of the trials but a therapeutic level equivalent to 4th or 5th cycle. 

 

qwerty22 wrote:

Are you saying can they get approval based on 6 or 12 or 15 patients?
No. 

If the results are astounding?
No

 

scarlet1967 wrote:

 

I am not sure how often they do imaging/blood tests so we soon find out but the thing which has baffling me is if throughout the trials the efficacy benefits due to MTD stops at 4th and 5th cycle after they have taken the data to 3+3 and another 3+3 and another.,, would that dosage be good enough for FDA and the drug would have a significant therapeutic benefits to be commercialized? in a sense what I am thinking do the early sigh of efficacy although stagnant during the trials would be determined as success or failure?

 

juniper88 wrote: I feel it is still too early to have any kind of efficacy signal.  Basically, there are 2 ways that the oncologist use to determine if there is efficacy from a treatment.  First, there is blood work for a tumor marker.  This is usually done a couple of days before the next treatment.  However, not every cancer has a reliable tumor marker and not every patient is sensitive to the tumor marker.  The second, and ultimate way to determine efficacy is by doing a CT Scan or MRI (depending on the cancer).  Usually those are only done after a certain number of treatment cycles, usually 3 or more cycles.

I doubt that Thera would say anything about efficacy based solely on the blood work.  It would be exciting for them to see but not reliable enough to publish.  And I doubt a CT Scan would have been done at this point, they are expensive and a lot of radiation for the patient.

If there is any update related to the trial it might be more generic, like how many patients are enrolled.  Maybe, results of how much free taxol was found in the blood, but I doubt they would publish that.

More likely the update will be related to more preclinical work that was done. 

All this is just a guess on my part, but we will see in less than a week.

 

 

scarlet1967 wrote:

This is what I have been thinking about a lot, the forth cycle 200mg/m2 completed May 24 and fifth cycle 300mg/m2 completed June 14 absent toxicity both are at or above the therapeutic dose of docetaxel so in theory if they had the second patient prepared to participate after the first patient passed away they could have observed tumour regression already with other words since their PDC only needs one quarter of docetaxel dosage to show efficacy they could determine the efficacy before the MTD. Another question I was asking myself was if after 5th cycle their PDC reaches the DLT and taking that data to future 6 patients still same DLT how commercial would the drug be at 300mg/m2? I would like to think even the MTD  is at those levels which is better than docetaxel alone there is a valid argument to get it approved and commercial the drug.

 

SPCEO1 wrote: Maybe we will get some clinical milestones on Monday. The new website says about TH-1902: "The Phase 1 clinical trial includes a dose-escalating part to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902".

So, maybe we will hear something about the preliminary anti-tumor activity and that will start to lower the clincial risk and vastly increase the potential reward of investing in TH.
 

 

Wino115 wrote: Those are exactly the right questions to ask and with their investor strategy, they must assume they  are near the bottom of investor attention, as you say.  All of this is far easier with clinical success which brings into focus the future of the pipeline. We and these new investors who bought in see reason to be hopeful, but the rest of the market won't notice anything unless the clinical data is highly supportive.  

If we can get to that point, it will be very interesting to see analysts stumbling over each other to understand what's happening in their trials (we can still hope!).  If the data goes the right way, it will be one of those cases where anyone even loosely following it will happily miss the first move, however strong that will be, and get on once there's a lot less risk, but still a nice reward. We're already up 100% from last years bottom and really only 4 investors got half of that. It's quite amazing how much money many investors are happy to leave on the table to wait for confirmation. 

One way we used to think about it was that you could actually "earn" the same dollar amount for your investors because at this stage of THTX where there's perceived clinical risk, you wouldn't invest as much, so your $ gains would be, say, X$ if you get it all right.  The alternative is you wait for confirmation, invest 4 times as much for the last chunk of gains and you still end up with X$ as profits and didn't have to take the clinical risk.  It's hard to argue with that approach provided the volume is there later. 

I just want to get to the data stage so we have the foundation to support this capital market strategy fully. 

qwerty22 wrote:

It's a great article but in a way there is an assumption in it of building from a neutral place to success. But that doesn't quite fit with THTX because they've pretty much been on the typical biotech rollercoaster ride and are at the bottom. So it's more than just building relevancy, there's restoring reputation having burnt all their bridges. I think my mistake  was to think they could do that more quickly with NASH but that's dragged on and been less than straightforward.

2021 looks like the moment to finally start rebuilding, the ongoing lack of interest is frustrating and perplexing though.

I like the article, I like the idea of constantly working at making yourself relevant but I think that work only pays off when it syncs with other aspects of the business.

Where they just not doing this relevancy work in 2019/2020? Where they doing it but doing it badly? Where they doing it but pushing against a locked door? With the 2021 milestones will the doors open?

 

 

 

scarlet1967 wrote:

 

 

I believe all the below from that article applies to the whole market, stock markets is mostly a closed system so the the same capital goes around between all listed companies, meaning there is a significant competition for those funds whether the source of money is the retail segment or institutions. Those who managed to master the “relevancy challenge” by doing all this article is referencing to and more will be the ultimate winners. Specifically for R&D companies it’s all about selling their programs.

 

“There are two ways for a fund to make room for new “core” positions. They can sell out of a position, believing their capital is better deployed elsewhere (due to either valuation levels or a loss of conviction on the biotech’s prospects). 

 

So all these trends highlight the “relevancy challenge” in the biotech equity capital markets today: in an ever-expanding world of names, where the “supply” of possible core positions is outstripping “demand” for additional core positions, how does a biotech become or maintain relevance to the best long-term investors?

The obvious answer is to have an unusually compelling story to tell with great data revealing huge potential for transformative impact on patients. Much easier to say then to truly demonstrate, and “compelling” for an early stage story is often in the eye of the beholder.

 

This includes detailed investor outreach plans built around the company’s key milestone/data releases, as well as medical and scientific meetings, publication strategies, and investor conferences.”

 

SPCEO1 wrote: Interesting article. Here is the concluding paragraph:

The bottom line is that achieving and maintaining relevance with the top buyside funds in an ever-expanding universe of investable opportunities only comes through hard work and planning, plus a healthy dose of good fortune in R&D. This buyside relevancy is critical to getting the attention required to access funding at a reasonable cost of capital – which is an existential requirement for success in loss-making R&D-stage biotech over the long term.

https://lifescivc.com/2021/06/biotechs-relevancy-challenge-in-an-expanding-universe/
 

 

 

I believe all the below from that article applies to the whole market, stock markets is mostly a closed system so the the same capital goes around between all listed companies, meaning there is a significant competition for those funds whether the source of money is the retail segment or institutions. Those who managed to master the “relevancy challenge” by doing all this article is referencing to and more will be the ultimate winners. Specifically for R&D companies it’s all about selling their programs.

 

“There are two ways for a fund to make room for new “core” positions. They can sell out of a position, believing their capital is better deployed elsewhere (due to either valuation levels or a loss of conviction on the biotech’s prospects). 

 

So all these trends highlight the “relevancy challenge” in the biotech equity capital markets today: in an ever-expanding world of names, where the “supply” of possible core positions is outstripping “demand” for additional core positions, how does a biotech become or maintain relevance to the best long-term investors?

The obvious answer is to have an unusually compelling story to tell with great data revealing huge potential for transformative impact on patients. Much easier to say then to truly demonstrate, and “compelling” for an early stage story is often in the eye of the beholder.

 

This includes detailed investor outreach plans built around the company’s key milestone/data releases, as well as medical and scientific meetings, publication strategies, and investor conferences.”