RE:RE:RE:RE:RE:RE:Form 10 registration statement just filedMy wholly non-scientific conjecture is that the did the initial generic and widely used rubicin and taxol versions. I recall the original discussion was 1904 works really well in ovarian and 1902 in TNBC. Then as they widened out the types of tumor cells and in vivo experiments, they saw 1902 did fairly well in ovarian and endometrial too, so why bother with rubicin as it doesn't really add anything to the platform. I think SN38 could be both a commercial rationale (the natural market is there with knowledge around Trodelvy in the oncologist office). It would be compelling to say here's our version, limited side effects, wider therapeutic window, more chemo into tumor cells, and you already know it's potent effect. I'm sure there's a scientific rationale too which I don't know. I think it's more potent in some of these cancer types, maybe there's something around resistance benefit, or something around it being a good combo with immuonherapies which they've said they're experimenting with. Just my guessing here.
SPCEO1 wrote: They did mention previously they were moving away from TH-1904 to SN38. Nothing new there but I think it would be interesting to speculate why they have done this. I am not scientifically adept enough to do so myself. They were initially more interested in TH-1904 than 1902. What does SN38 bring to the progress of the Sort1+ program? Is that a natural progression from a science perspective or does it tell us about some potential flaw in 1902?
qwerty22 wrote: "The Corporation has reduced the time spent on preclinical work on TH1904, its second PDC derived from its SORT1+ TechnologyTM, and has begun working on other PDCs, primarily to advance a PDC using SN38."
I think that's new. I don't remember it being stated that clear about what is happening preclinically. I think we've been speculating on this.
"To date, the study has dosed several patients with tumors for which no known effective therapies exist"
I'm curious why they keep using that statement. It might just be a throw away line but it also could have some significance. Maybe it's just to emphasize the potential utility of the tech.
The most bullish scenario I guess is they have some (an) unconfirmed response and they are waiting on the second scan to confirm it.
SPCEO1 wrote: Yes, I think it is just an updated version of the one filed not too long ago. Here is the description of the phase 1a in this version:
The Corporation’s Phase 1 study evaluating its novel investigational proprietary PDC TH1902 for the treatment of sortilin-positive cancers is progressing as planned. To date, the study has dosed several patients with tumors for which no known effective therapies exist, with some receiving more docetaxel, when conjugated to TH1902, than the indicated dose of docetaxel alone (80-100mg/m2). Patients that have received up to 300mg/m2 of TH1902 (the equivalent of 130mg/m2 of docetaxel), or approximately 1.5 times the indicated dose of docetaxel, have not experienced any grade 2 adverse events. One of the patients dosed received 420mg/m2 of TH1902, or approximately two times the indicated dose of docetaxel, and experienced a grade 4 adverse event (neutropenia). After review of the data related to the grade 4 adverse event, we will continue enrolling patients who will be receiving 420mg/m2 of TH1902 as per the protocol. Part A of the Phase 1 trial is ongoing until the MTD is identified.
The Corporation has retained the services of a contract research organization to assist with the conduct of its Phase 1 clinical trial.
The Corporation has reduced the time spent on preclinical work on TH1904, its second PDC derived from its SORT1+ TechnologyTM, and has begun working on other PDCs, primarily to advance a PDC using SN38. Nothing new there as far as I can tell.
But TH's ducks are likely all lined up now to raise money quickly. Hopefully, if they need to raise money they do so after good cancer news and at much higher prices.
As one reads the info on NASH, one is reminded again how hard this still will be to get the trial going using the F8. They are going to file the F8 for approval with the FDA in the first quarter, but the pen injector, despite using old technology, is apparently more complicated than one might think. I think they will be able to get over the NASH hurdles ahead of them but they most likely will be doing those first 400 patients on their own.
palinc2000 wrote: Looks to be just an amendment to previously filed form 10