RE:RE:Chinese drug development https://ir.bioatla.com/static-files/4a2acc24-003a-420e-a605-778b658dcc8d
These guys seem to be responsible for one or two of those ADCs with Chinese INDs. Haven't discovered if it's partnered in China or they went forward alone. Even just the regulatory landscape on it's own must make China attractive to companies. The reason for posting is p13 of the presentation. It shows the decision tree for go/no go on the interim analysis. Given it's n=10 for each cancer type it in some ways matches THTX's 1b expansion phase. You can see from that diagram that a go decision comes from just 1 (out of 10) PR/CR or Progression Free Survival of 12 weeks+ in 4 patients. So the bar is relatively low for the program to continue in these early trials. I would think THTX will be making a similar decision when they get to the expansion 1b phase. It should also be noted that they have done the necessary all-comer phase to see where their cut-off lies in terms of target expression and it looks like they are pre-screening from Ph2 onwards. This is also the 2 nd company I see using % of cells expressing the target as the metric they use, rather than looking at overall staining intensity of the sample. I don't think THTX have landed (publically) on a method of quantification of target, they certainly don't have a cutoff value yet. It'll be interesting to see where this goes once they have the data.
This company has a value similar to THTX although last year it was very much higher. Not sure what happened to them, maybe they just deflated along with the rest of biotech. A $200-$300 mil valuation on THTX's early stage cancer program seems justifiable, if biotech was a bit hotter maybe more.
(there's more in that presentation to like, worth flicking through I think)
Wino115 wrote: Eye-opening data for sure. So maybe the thought is that once you validate a successful oncology target, you are far better off partnering quickly inside China to give one firm a solid lead around it before 20 copy cat versions come out targeting your receptor like all those PD-1 ADCs in trial. After all, THTX does not own sortilin, just their SORT1+ technology.
qwerty22 wrote: https://www.pharmadj.com/en/cms/detail.htm?item.id=1609c6932bf711ecbee6fa163e42049a Some amazing stats in this article on oncology drug development in China. Amazing that the Chinese regulator has cut the IND approval time from 16 months to 60 days. ADCs get a strong mention. While there is a lot of copycats in the PD-L1 it looks like there is also a lot of companies prepared to take on innovative targets in the ADC space.