RE:RE:Re-listened to the Q3 conference callA couple of additional thoughts about this - I don't remember the rat data, so I can't help you there. My 62 year old brain is still pretty good but remembering all those details is probably not happening anymore! I imagine that was in the cancer KOL presentation so we could go back and see if they said it there.
Also, much that small biotechs do and do not say about their trials is completely tied to fundraising. If they are in no need of funds, they might tell you more info more quickly. But if they are looking to raise money, as TH is, they will curate the key info for maximum impact on the share price prior to the fundraising. I suspect we have that going on with TH right now. They clearly could tell us more info on the efficacy side of the equation as they likely have bloodwork data that either is or is not lining up with their pre-clinical work. Based on their effusive comments, it is easy to think they are curating positive info on efficacy for a timely pre-share offering release. Remember how they bombed us at the same time with the FDA's good to proceed letters on the NASH and cancer trials when that info came in from the FDA a couple of weeks apart, not to mention the preannouncement of good legacy drug sales and an expectation of much more to come. So, companies do regularly curate their news and also even lie just before a share offering.
Now, the risk is all of the effusive language around the phase 1a is to pump investors up about cancer's prospects and they actually plan to raise money before announcing any phase 1a efficacy data because they know it is not what investors are hoping it will be. I doubt such a strategy would work very well but it likely would work better than raising money after announcing sketchy efficacy data. And we know that finding good efficacy data is not likely going to be easy in the phase 1a given the small number of shots on goal they likely will have.
On another topic, I listened to a KOL present on the HC Wainwright Precision Oncology conference today as well as Prelude's presentation there. I am still not sure why TH was not on the agenda as there clearly was room for more companies to present. In any event, TH's pitch with TH-1902 is so much simpler and cleaner than what I heard. Its simplicity might prove to be a weakness with the cancer analysts who are likely looking for something more complex like these other companies offer. In the end, however, if it works, it works and there will be no denying that.
Prelude is also using Docetaxel in at least one of its compounds and I heard the presenter say something about getting 600 or even 800 Mg of Docetaxel into patients via their methodology. Given that TH is seeing neutropenia at 400 mg, that was notable. Now, the presenter was not always easy to hear and I would really like to see a analyst report on Prelude so I can get a better understanding of what they are doing but it sounds like they have 4 compounds and one of them saw a partial response in phase 1a and another saw a durable complete response in gioblastoma. They presented a ton of data at a conference recently and the stock got crushed after that so something about it clearly was not good.
qwerty22 wrote: I think it's the absence of an efficacy signal at this point that's got me a bit jittery. It would be nice to have some sort of efficacy alongside this neutropenia in order to feel more confidence that they had a therapeutic window to play in.
I'm trying to forget my expectations that built up based on the pretty clean mouse data. I have a memory that Paul said a while back that the rat toxicology data indicated DLTs at 3x normal docetaxel dose and that seems to be bang on what Christain is saying here. A lot of what I'm focusing on might be in that rat preclinical toxicology data. I've seen companies publish that data as a companion paper to the preclinical paper thtx already published. I'd take that 2 nd preclinical paper while we wait for efficacy.
Am I remembering right about the rats having DLTs at 3x dose?
I think it's reasonable to take them at their word. I think I always said whatever curiosity I have around the neutropenia it's far from anything fatal for the program. I guess I'm not expressing thing in such a positive manner though!
SPCEO1 wrote: It is always good to re-listen to these calls because I find you always pick up on things you did not hear the first time around.
What I did hear the first time around was a lot of enthusiatic comments about TH-1902. But upon listening again, it was even more striking. We know they are much more aware of things that are going on in the phase 1a trial than they are currently letting us know about, but it is apparent those things are leading them to characterize their hopes for this trial in a very, very positive way. So that is encouraging.
On the issue of the neutropenia and reaching the MTD, Christian indicated no surprise at all about the neutropenia at this level of dosage and said they know they are already close to DLT's. He made a comment that basically said they know some Docetaxel will get into healthy cells but beleive more will get into the cancerous cells. So, while we did not get a description of exactly how Docetaxel is getting into healthy cells they clearly expect it to at some point. That may be something for Qwerty to give some thought to. If you want to listen to it, it came at the 40:25 mark of the call. BUt what I heard was they totally expect neutropenia at some point to occur and it probably will occur sometime around where they are at now in the trial.