Theratechnologies Inc T.TH

From the Annual Information Form

[jfm1330]

On November 18, 2020, we submitted an IND application to the FDA proposing the development of tesamorelin for the treatment of NASH in the general population in a Phase 3 clinical trial. The proposed Phase 3 clinical trial design will enroll participants with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis. Participants will be randomized 1:1 to receive 2 mg of tesamorelin or placebo. A second liver biopsy will be performed after 18 months of treatment for the first 900 participants, approximately. These data will form the basis for filing a sBLA with the FDA to seek accelerated approval. The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo. Participants will remain in the Phase 3 trial for a total of 60 months. Subject to further discussions with regulatory agencies, approximately 2,000 participants in total are expected to be enrolled, including a cohort of approximately 75 to 100 participants with HIV

[jfm1330]

In late December 2020, the Corporation received a “Study May Proceed” letter from the FDA in connection with its IND application to develop tesamorelin for the treatment of NASH in the general population. The letter contained a recommendation that the Corporation requests a meeting to discuss the questions and comments contained in such letter to address certain aspects of the proposed trial

[jfm1330]

Acquisition of SORT1+ TechnologyTM The research and development activities carried out on our peptide-drug conjugates TH1902 and TH1904 stem from our acquisition of all of the issued and outstanding common shares of Katana Biopharma Inc., or Katana, on February 25, 2019. Katana had the exclusive worldwide rights, through a royalty-bearing licence agreement, entered into with Transfert Plus, LP, or

[jfm1330]

Research and Development Activities Sortilin, or SORT1, is a newly identified receptor that plays a role in carrying large molecules across the cell membrane. It was discovered that SORT1 is overexpressed in ovarian, triple-negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking via the

[qwerty22]

I got a question for anybody that understands IP. THTX has IP for the delivery of chemo to cancer cells via sortilin. A Swedish startup has IP for the inhibition of Sortilin for cancer therapeutics. https://www.freepatentsonline.com/y2017/0096486.html I can see how both those are separate claims and don't infringe each other. My question is does this Swedish IP limit THTX from making

[jeffm34]

https://www.nature.com/articles/s41419-019-1449-9

[jeffm34]

https://pubmed.ncbi.nlm.nih.gov/24355129/

[scarlet1967]

https://patents.google.com/patent/WO2017088058A1/en

[scarlet1967]

Γ0018 In another aspect, there is provided a method of treating a cancer comprising administrating a therapeutically effective amount of at least one compound herein disclosed to a subject in need thereof.   Γ0019 In another aspect, there is provided a method of treating a cancer involving sortilin expression comprising contacting at least one cancer cell expressing sortilin with at least

[jeffm34]

TH would be smart to acquire or license in any Sortilin IP they can and become one of the leading companies in all things Sortilin related.  

[jfm1330]

There is no patent that gives exclusive rights to the use of a natural receptor. The patent is on the peptide interacting with it.

[jeffm34]

Obviously. There is other work being done to develop potential therapeutic agents that target Sortilin. 

[jfm1330]

No news here, I posted that a few months ago and mentionned in response . to Wino a few days ago. I am not sure, but Transfert Plus looks like university related organism. It looks like a way for UQAM to get a little something in return, in case of commercial success, for financing Beliveau and Annabi's labs. Both are professors at UQAM, so also paid by the univesity. I think it is is

[scarlet1967]

I am the best here at misspelling! I hope that "organism" doesn't suck the blood of THTX's future billions of profit.