RE:Sortilin and Eyesight - side effect vs efficacy "Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients."
Reads like the obituary for the drug. What in that sentence is there to be hopeful about? Unconvincing efficacy and adverse events large enough to induce a voluntary halt. Obviously we'd need to know more but at this stage I'd be surprised if any more patients ever get injected with this drug.
This sounds like a rapid response to a recent nasty safety signal. One so big they know the FDA would have called a halt so they jumped before they were pushed. Something that is similar to but a step up from what they saw in 1a and maybe what's been developing in 1b so it can't be dismissed.
Presumably they need to get the board together. Presumably this looks like a huge impact on the business plan of the company going forward. Presumably that might mean layoffs of many of those recent hirings. Presumably all that needs to be worked out before they make any more statements.
I'm with JayJay and Wino. It doesn't sound like the typical docetaxel toxicity pattern. This is most likely a Sortilin specific thing. For Th1902 to progress it seems to me there'd need to be some specific piece of info they are seeing in some result that suggests a change of dose would lead to a change in the pattern of binding to eye, nerve and tumour cells. There's no hint in this PR that such info exists. I'm struggling to imagine what that info would even be. I can't see Th1902 going forward. I can't imagine how any other general cytotoxic payload could move forward, so I think Th1902 takes down Th1904 with it. If they are committed to keeping the SORT1 tech alive then I could imagine a payload that had a very specific mode of action like an siRNA or something that targets onco specific processes might work but that means going back the R&D/preclinical phase. More powerful chemo sounds like the same outcome only worse.
If TH1902 is not moving forward then that must have a huge impact on the business plan. I think getting a new plan in place is where they are at now. Getting the board to agree that is what is needed before they talk publically again. I am in full sceptic mode here. I'm seeing Th1902 dead. I'm seeing the path for any version of SORT1 based drug as going back to the start again.
The stock will get thrashed. There will be a re-evaluation of what THTX is based on legacy drugs and whatever expenses will look like for the new look THTX. I expect it gets uglier in the shorter though.
Pretty much how horrible biotech can be.
JayjayUSA12007 wrote: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338683/
This study is evidence that Sortilin is associated with the eyes.
Since TH902 is designed to attach to Sortilin, it causes the side effect to the eyes.
On the other hand, this so-called side effect indirectly shows that TH902 works as expected on human, since most cancer cells have Sortilin expressed on its surface.
As such, this is the question of Risk vs Benefits. The new trial protocol amendment is to strike a balance between them.
Furthermore, as TH902 is designed as salvage therapy, its benefits would likely weight more than potential risks, given these patients' conditions.