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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

Post by Wino115on Sep 29, 2021 11:28am
166 Views
Post# 33936863

SORT1 Intro transcript from PL

SORT1 Intro transcript from PLSomewhat paraphrased, but what he said.

"....have something very unique...We see very wide application. We received fast-track. Very hard to talk about the population that can be using this because for now the fast-track is based on it being tumor agnostic....   At very least be relevant for ten thousands of patients.  I think it will be a major, major addition to the treatment arsenals.  Need to complete escalation trial, have to do the basket trial afterwards, and our goal is to take AT LEAST ONE of those indications and accelerate the development."

What do you Expect to announce question:

"Everything is going well, dosing patients every cycle....Now and end of quarter we should have some data on what is the MTD because that's what we're trying to identify. ....  Foresee basket trial to start in first quarter 2022 in 5 tumors, all with high unmet medical need ....obviously if it pans out the same way it did in the pre-clinical work, we should be able to see a dose that is better tolerated at dose equivalent docetaxel level and somehow we should be able to, down the road, pick up some efficacy data.  The dose escalation phase is not meant to actually see much efficacy because it's all comers and don't know patients have SORT1 expression.  We just try to establish safety.  But it could be we see one patient with high levels of sort1 expression receptor that we see some early sign of efficacy.  If we see that between now and Christmas that's the kind of information we would share with Wall St and our investors. "

Sounds to me like they have seen some data on the correlation between SORT1 receptors and efficacy and it's what you'd think -- a highly positive correlation.  So given the small number of patients in the dose escalation phase, they'll be lucky to have 2 or 3 with very high levels and can show that those with higher levels showed better efficacy.  That would correlate with the pre-clinical work. Given that info and perhaps on what tumors it worked best on, maybe they'll tweak the extension trial numbers or at least do the tumor staining for SORT1 prior to accepting patients in extension.  But does appear he's restating what was said before, that if any efficacy signals are seen, they would announce it. If none are seen, we'll have to wait for the basket trial to end to get a read on efficacy. 

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