Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

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.

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Theratechnologies Inc > Dose escalation

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Comment by SPCEO1on Sep 09, 2021 1:06pm

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Post# 33834103

RE:RE:RE:RE:Dose escalation

I don't have a Smile-O-Meter. I think that was Palin or JFM. But, hopefully, we see a lot of smiling! I am just worried that few others than ourselves will even notice. THTX must be concerned by the loss of analysts over time and the very low trading volume seen on some days recently. While there is good reason for things to be moving forward on both of those fronts, they nevertheless seem to be moving in the wrong direction. Some alarm bells should be ringing at THTX headquarters.

qwerty22 wrote:
1) I think 2.4x is about the highest scheduled dose so dosing last dose about now and finishing that cycle early Oct. Seems to fit. If there has been any DLTs then the schedule gets thrown off as they re-dose at the same level before moving on. You're early Oct assumes no DLTs
2) MTD will get announced with all the rest of the data, just because they haven't said something yet doesn't mean diddly-squat. That's an assumption on JFM's part.

Generally though at 2.4x normal docetaxel levels you would hope they'd see some efficacy signs by now. Get your smile-o-meter out for the NASH event and let us know if Christian's and Paul's smiles as as big in the cancer KOL event!

SPCEO1 wrote: A couplle fo questions about this:

1.) When I counted out the 28 week estimate for the phase 1a length, it suggested it would end in the first week of October but you have them starting the highest dose then. What accounts for that difference or how did you come up with the first week of October being the last step of the trial?

2.) If the trial had reacched a MTD already, I thought we had concluded that THTX might not be obligated to announce that. So, is it possible the trial has already ceased and we just do not know that yet?

jfm1330 wrote: So, in theory, we are into another cycle at a higher dose of TH1902 now, this is equivalent 2.4 times the MTD of docetaxel alone. It seems that the previous dose, at almost two times the MTD was of docetaxel alone, was not toxic enough to be the MTD of TH1902. All this is very good, in theory, still it is not a proof of concept.

jfm1330 wrote: Then, if they get there, it would be 558.6 mg/m2 on September 7, and 742 mg/m2 on October 5. This would be a bit higherthan three times the MTD of free docetaxel, which is what they saw on rats in the preclinical.