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 > Over $400k annually for…

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Comment by qwerty22on Sep 21, 2021 10:45am

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Post# 33891981

RE:RE:RE:Over $400k annually for…

Just to follow up on that. Some of the indications thtx has picked for part 2 (I'm thinking r/r pancreatic cancer) have a very short list of approved drugs and some of those drugs have very horrible looking profiles from an efficacy perspective (my memory is there is one drug with a 10-15% ORR in pancreatic cancer that got approval). If they see activity in pancreatic cancer for example you might be looking at a short path to approval.

qwerty22 wrote:

Another variable to consider is the treatment landscape for metastatic cervical cancer. The limited drugs approved may have lowered the bar on this one. It definitely looks like a mixed bag of results. It would be interesting to see the very earliest data releases on this program to see whether you could discern an approvable dataset at that time.

Another interesting number coming out of this trial is

"The median time to response was 1.4 months (range, 1.1-5.1), with activity generally observed within the first two treatment cycles."

Not so much for approval but for our wait for efficacy data now. This ADC shows a very fast measurable response at the start of treatment hopefully th1902 obliges in this way and helps with the wait time for an efficacy announcement.

Wino115 wrote:

Another ADC is good news, especially as the BLA was filed in Feb, Accellerated App granted in April, and now approved in Sep. All on phase 2 with 101 patients and an objective response of only 24% and durability of response of 8 months in cervical cancer, but with a high percentage of safety issues many of which are on the serious side (50% for hemoglobin and lymphocyte decrease and 40% peripheral neuropathy) .

So the ADC not internalizing a lot of the chemo clearly leads to issues with dosage, duration and treatment window. More numbers and a timeline to keep in mind. On that timeline, you could see TH1902 move pretty fast based on positive results.

scarlet1967 wrote:

“Tivdak’s wholesale acquisition cost is $5,885 per 40mg single dose vial, with patients’ individual costs determined by body weight and duration of therapy, a spokesperson said by email. The companies estimate an average WAC per patient per month of $34,000, before discounts or rebates.”

This ADC approved yesterday will gross estimated over $400k annually.

Seagen - Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer