Theratechnologies Inc T.TH

Very encouraging, but approval will take time

[jfm1330]

Finally we got some meat on the bone. Why did they wait six months to provide more clarity on efficacy related to stable disease. Why did they not tell us that some patients took the drug, stoped it and their cancer were stable for a long time afterward. It seems that they have a approvable drug based on progression free survival criteria, but it will take time to achieve that. It won't be a fast track approval. Also, it seems potential for combination therapy is high, also potential to develop other PDCs. Their problem now is money. They need to sell this story in a much better way. Also, potential for partnership is high because they need the money. Takeovers are rare in biopharmas/biotechs, but they clearly are a cheap target.

[jfm1330]

Got my SPECT scan yesterday using Ga68-Dotatate. It is so easy and they can see everything with high resolution, tiny tumors, all based on somatostatin receptor. Doctor Meric did a comparison what is done with ADCs, but TH1902 is not an ADC, it's a PDC, like Ga68-Dotatate. I know they don't have the financial means to develop that at this point, but it would be so helpful going forward

[jfm1330]

Another thing I learned today is that they do a biopsy on all patients before starting them on the drug. Maybe I missed it previously, but it changes the situation they are in. It seems that the FDA is asking them to do that, but not to use it as a selection tool. The FDA is also thinking in an ADC way, not in a PDC way. They look at how it was done before with ADCs, and forget that TH1902 is a

[SPCEO1]

To me, the biopsy situation is as clear as mud. It was mentioned in the poster and again today but I don't believe every patient is biopsied. My cousin was not biopsied as far as I know.

[juniper88]

My wife had the biopsy done.  And as far as I know it is mandatory for every patient.

[jfm1330]

Marsolais clearly said all patients have biopsies at baseline to do corellation with efficacy afterward. That being said, I will listen again tothe presentation since a lot of things were said. That being said, I think they have something in their hands, but they lack the financial ressources to drive it. They need a big partner with ressources to do many things at the same time. Now they will

[qwerty22]

Obviously more resources to throw at this the better but you're don't taking a practical approach here. Take the next trial. From the PR it seems 6+6 (+ a further4 if all is OK). That is presumably a restriction put on by the fda because they need to see how toxicity develops in this new regimen. Having billions in the bank wouldn't remove that restriction. Like everybody else you

[scarlet1967]

I don't think they mentioned the path to approval is SD even so having extended period of stable disease among heavily treated patients is impressive. The eye toxicity seems to be manageable by prophylactics the nerv issue based on Dr. Merci's past experience and as per Christian's comments(pre clinical observations) is supposed to be dealt with based on lower and more frequently

[SPCEO1]

I am no scientist but the toxicity did not seem to be very bad based on my understanding of what levels of toxicity other drugs cause cancer patients. It seemed to me the decision to pause was that the toxicity, while not as bad as many cancer drugs, was still not worth it based on the limited efficacy. Did I understand that correctly? Or was the toxicity bad enough on its own to stop the trial

[jfm1330]

My understanding is that they stopped the trial because the see this drug as a drug for chronic use, so longer term use and patients can stay on a drug for a longer period of time only if toxic side-effects are relatively low. In my fourth month of chemo, I can tell you that it is a very important criteria. You need to retain a decent quality of life to stay on a drug long term.

[jfm1330]

I know it's not very important at this point, but it's worth noting that if the new protocol works, this drug will be high a high maintenance drug with three IV infusions per month, every month. Better start thinking now about an IV push formulation!!!

[jfm1330]

About the new protocol, my understanding is that they want to lower the free docetaxel generated in the bloodstream, and increase the amount of TH1902 internalized inside cells for a given cycle. This is just my guesswork around that. It was not clearly said in the presentation, even though some comments by Marsolais towards the end pointed in that direction. So up to now in the clinic they saw

[jfm1330]

I thought about another way to illustrate what I think is happening with the fate of TH1902 in the bloodstream after injection. Instead of veins or arteries, think of it as a very long corridor, with some locked doors The density of locked door is high in some parts of the corridor (tumors overexpressing sortilin), and much lower elswhere to varying degrees. TH1902 flows in this corridor, and is

[Wino115]

It sounded somewhat along these lines from putting together a few of the answers they provided. I am sure there is way more science and nuance to understand it all and as that simple-minded layman, one  question I would have is how long is the process for sort1 to internalize, cleave the linker inside cell, and re-externalize to surface of that cell? This has been the slide they've used

[jfm1330]

In a recent press release they said half life in the bloodstream was 1 hour to 1.5 hours depending if the dose is 300 mg or 420 mg. It clearly shows that there is a traffic logjam to enter sortilin expressing cells, and while it stays in the bloodstream waiting for an open an ready sortilin receptor, there is degradation of TH1902. What we don't know is the rate of that degradation process

[SPCEO1]

Based on Juniper 88's comment and what you heard, I ithink biopsies were likely given to all patients, including my cousin and she just never mentioned it. But if biopsies were given to all, then should they not know the sortilin overexpression for each? Money is defintely an issue for THTX. I suspect the hope is they see some early success with the six initial patients, announce that and

[canadapiet]

Money IS the issue!!!!! We thought we had a great CEO with very "high" "important" connections with PFE! For them it is "pennies, nickels and dimes" to invest in TH's possible cure for some cancers..........!!!!! How long are they telling us they are in negotiations with possible partners????? Hilarious but really sad and a pitty for those who suffer

[qwerty22]

I got the sense Christian was being deliberately opaque on the question of Sortilin expression. He seemed to be happy that what they were seeing fitted with the general picture of say high expression in Ovarian for example but he seemed unwilling to go further. My presumption is there is no pattern between efficacy (or toxicity) and expression atm in their enrolled patients, that's likely

[qwerty22]

Just to add to this based on a re-listen. Towards the end Christian does say that "most" of the enrolled patients had H-scores greater than 100 so that would confirm they'v done the post hoc Sortilin analysis and the results presumably fit well with the findings from the commercial slides they studied preclinically. I think also he said they've now tested 2800 different tumour

[jfm1330]

My understanding is that it's the FDA that are asking them not to select patients based on biopsy confirmed sortilin overexpression. They want the biopsy results for afterward correlation between efficacy an sortilin overexpression. In other words they want so low sortilin patients in the mix just to ultimately confirm that efficacy is related to sortilin overexpression and that the

[PWIB123]

I specifically asked a question about the expected time frame to see results that would inform their financial decision on when to make cost cuts in order to be cash flow positive by FYE.  The call was set up to discuss the science, but I was hoping they would provide greater insight into the financial trajectory.  Needless to say, they didn't answer the question.  Hopeing for