Theratechnologies Inc T.TH

Breakthrough Therapy

[jeffm34]

Criteria to apply for BTD
 "A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy"

They should know if this is the case with TH1902 within a couple months and could apply for a BTD 

[Lee430]

Historically at what point in a trial has the FDA typically granted BTD status?

[SPCEO1]

I am not an expert on this but I think at the end of phase I is likely most common. If the fDA thinks you ahve somethign important, they likely want to identify it early and speed its progress through the trials. But BTD can come anytime the FDA thinks they see something worthwhile. 

[Wino115]

It seems it is when you show preliminary clinical evidence it is safe and an improvement over existing therapies.  Trodelvy (the ADC targeting TROP2 on TNBC that is refractory that Gilead bought for $21bil) got priority review  and BTD after Phase 1 data given both the unmet need and a response rate of 33% and additional 7.7 months survival.  Then they got accelerated approval

[Wino115]

should say "..it did NOT have fast track..."

[SPCEO1]

I believe you meant 1H22 for accelerated approval. Which would be incredible if anything remotely like that happened. The potential for such an outcome is there, however. Sure wish they had been a bit more willing to share more early phase I data last Monday so we could really start calculating the long odds on something like that. 

[qwerty22]

You're statement there just speaks to the idea that the first approval brings along more than just the value of sales in that first indication. They have to be seeing it doing other things like move up the treatment pipeline for TNBC, into new indications etc. Did they buy the molecule or the patent? Maybe they see a family of molecules based on the IP. This would be part of the argument for

[scarlet1967]

It seems unlike fast track designation the BTD can’t be requested at IND stage, the drug needs to show safety and good efficacy among others to be considered for BTD. It could be as early as during phase1 but ideally not later than end of phase2. It is somehow hard to look at historical examples. The PDC  technology is quite new compared to  specifically traditional

[scarlet1967]

For instance during webinar it was said that 230mg/m2 of their PDC is at or above 100mg/m2 Docetaxel( therapeutic dosage for docetaxel alone) by end of sixth cycle, no toxicity they will reach 560mg/m2 which is over 240 percent above Docetaxel’s therapeutic dosage. That is if confirmed a very good indication that good or great efficacy could be reached thus a tumour regression as a result by end

[Lee430]

Thank you all for your valuable feedback, I am now having difficulty wrapping my mind around the full potential benefit both financially for myself & for those in our lives who have suffered from this horrible disease.

[qwerty22]

It's going to vary with indication. There are some cancers in the basket trial that have significantly higher unmet medical need. R/R pancreatic looks awful, once first line drugs are no longer working the remaining drugs looks to have quite poor profiles, from memory one drug got approval on a 10% ORR. If they had a response in pancreatic the first thing you can say is the potential for clear

[Wino115]

In the past you have mentioned the various indicators that oncology trials report on --things like ORR Overall Response Rate (made of PR+CR, partial response plus complete response), PFS Progression free survival, OS Overall Survival, DoR Duration of Response being the key ones along with the Tumor response criteria (RECIST).  Each of the tumor types they are testing has different "best

[scarlet1967]

I believe all late stage cancers would qualify as unmet condition unless their PDC shows efficacy in earlier stages of cancers. As per now they are treating all comers as FDA wants to  see the correlation between the activity of the PDC and expression of receptors in humans (to determine the expression of receptor in relationship to efficacy of the drug), but they will be screening patients

[scarlet1967]

Paul last slide was suggesting they are open to change the design of the trial for instance dosing schedule (weekly, intermittent versus continual) exploring a combination of their sort1 technology with other treatments specifically immunotherapies., exploring conjunction with variety of chemotherapeutic agents and potential synergistic new partnership (proprietary molecules) so they will be