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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Comment by SPCEO1on Mar 15, 2022 11:22am
116 Views
Post# 34515140

RE:RE:RE:RE:MTD

RE:RE:RE:RE:MTDThey simply said they expected some patients in the 1a to carry over into the 1b. I concluded from that they may see preliminary signs of efficacy earlier in phase 1b since they will already have had some treatments in phase 1a. That assumes TH has not already seens preliminary signs of efficacy in phase 1a anyway - if so, it does not matter much. But we also do not know what cancers that over express sortilin receptors have been part of the phase 1a trial. If all of the last six patients at 300mg were non-sortilin overexpressors, that will not help much. If three of them were and they had three different cancers types, then there is a chance we could see evidence preliminary efficacy pretty quickly in one or more of those three early in phase 1b.

Thanks for digging up what you can on the stem cell issue. 

qwerty22 wrote:

2) Speaks to a minimum of stability. Alternatively it could just be a more general statement that in these sorts of trials you might expect some of the 1a continuing on treatment into the 1b phase. Do you think they were actually speaking of the experience in this trial or a more general experience with cancer trials?

7) I'll have a go at this. Here is one published paper on CSC inhibition by a drug, there are many.

https://www.nature.com/articles/bjc2013534

One small part from it.

"Although the role of CSCs in tumourigenesis is still debatable, it is widely accepted that the cancer cells expressing stem cell markers are highly resistant to radio- and chemotherapy and are the sources of cancer recurrence (Bjerkvig et al, 2005Dean et al, 2005Clevers, 2011). Also, the cells with CSC markers are resistant to all different anticancer drugs. Therefore, CSCs may be the cause of pan-chemoresistance that is a common and a very serious problem faced in cancer therapeutics. Elimination of these cells may improve the outcomes of cancer chemotherapy."

So a very simple answer to why the stem cell work is exciting might be that the cells that make up the tumours in their late-stage patients might be more similar to these test cells than the 'ordinary' cells they've been using so far. They have a whole bunch of properties that need to be overcome and this in vitro/ in vivo work is showing th1902 does this better than docetaxel.
 

SPCEO1 wrote: I am one of those large shareholders that do get access that others might not. For the first time since the ONO, I spoke directly to the CEO and CFO today and, as always, I am happy to share with my fellow longsuffering shareholders what I heard. So, unlike most other stocks you might own, you still have a front row seat with THTX. And the view from those seats remains promising on cancer.

Here are some meaningful things I learned today:

1.) While they do not explicitily say so, it is clear TH-1902 is on a good path given their actions and the general vibe of the discussion. For example, they referenced a meeting they had earlier today in which Dr. Rothenberg participated where they were discussing how they could best optimize the future trials of TH-1902. You do not need to discuss such things if path ahead is not looking good. We cannot know exactly where they are on the path or what the actual results will be until they report them to us, but we can reasonably assume things are good path at this time and that we have a pretty good chance of being happy shareholders again in the not too distant future.

2.) Some of the patients in the phase 1a will join the phase 1b. As a result, it seems to me that THTX will have a very good headstart on determining preliminary signs of efficacy early in the phase 1b if that has not already been established in the phase 1a. Whether in phase 1a or phase 1b, we might have evidence of efficacy before June in at least one cancer type (that is me talking, not THTX).

3.) Once they have an efficacy signal, they will approach the FDA about starting a phase 2 trial. The phase 2 trial will likely start before the phase 1b is completed.

4.) Assuming normal trial timeframes, they think the first version of TH-1902  for some type of cancer could reach the market in 2025. It may be in a small cancer market, such as Thyroid cancer that apparently has very, very high sortilin receptor expression, as the view is it is important to get something across the finish line fast and then expand from there. Of course, I imagine they would have other cancer type trials running too as soon as they have efficacy data that is positive on those other cancers. I did not have a chance to ask if this timeline assumes anything about a BTD being granted.

5.) They mentioned another stock that recently did a $100 million debt financing - URGN is the  symbol. I have not had time to look into it yet but it sounded like this might be an example of non-dilutuve financing they are looking into. URGN stock price jumed over 33% on the news of their deal last week but I really have not had a chance to understand why and I am sure there are signfiicant differences between the two companies.

6.)  They apparently have partnership deals in China they could move forward on but they are looking to make sure they optimize this situation. If they can get the top tier of Chinese drugcompanies interested,it may be a few months before they finalize anything on this front.

7.) In the pre-clinical results announced last week they said the stem cell data was important but we did not have time to discuss why.

8.) I complained very loudly and as obnoxiously as I could to make sure the message was not missed that their interaction with the investment comunity is a five alarm fire that needs to be addressed yesterday or earlier. Unfortuately, I did not get any indication that they see it as a huge problem, so that remains disconcerting to say the least. Data will move the stock higher but data combined with effective communications with the market will optimize the situation. I told Paul that he was meeting this morning to optimize the TH-1902 trials and that he also needed to meet to figure out how to optimize their relationship with investors. Don't hold your breath for significant imporvement on this front as we have already learned from years of misery. It is hard to understand how this abysmal situation has been allowed to go on for so long while getting worse rather than better. It was an ugly part of our interchange but it needed to be. 

9.) They are about to make an offer to an IR person. That may help some but until there is a change in attitudes at the top, any new IR person will probably at best be marginally effective.     
10.) On the analyst front, they are still stuck. No analyst coverage until a deal is done. If they start putting out impressive data on human cancer trials, however, maybe an analyst or two will pick up coverage at some point. If they do a debt financing like URGN, I suspect only debt analysts will pick up coverage. So, that would not be what we are looking for. 

11.) They reiterated what they said on the Q4 conference call that Q1 was looking good.

I think we will know a lot more on cancer between now and the cancer conference at the end of June. 300mg is likely the dose they will use going forward and it should allow THTX to safely addminister a dosage that is 1.5x that of normal Docetaxel, then multiplied by a further 5-7x for what actually gets into the cancer cell and then given more frequently and for a longer period of time. If that is how things actually work out, then we have a good chance of seeing the stock move much, much higher in the short and long term.   

 

Trogarzon wrote:
Also from what I understand, they could get 300mg MTD and use like 200mg or 250mg if it gets the job done and improves the longterm tolerability. Even at 1 times MTD it sends a multiple of Dox to the target area. That being said, it is miserable time for the whole world atm but I personnally find it inexcusable to be at the actual market cap. The most important thing for someone dying of Cancer is hope.. a patient witout hope dies a shareholder without hope sells Thera you are giving hope to a few big shareholders (special meetings) who can then prey on small disgruntled longterm and faithfull shareholders that throw down the towel for lack of HOPE.

 




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