More on the Meeting with ManagementAs I noted earlier, one big takeaway from the meeting was the comment that the results they are seeing in humans matches up pretty closely with what they saw in their preclinical work. If that is an accurate assessment, we should have a lot to look forward to. They also said on more than one occaision something to the effect that the trial is "going very well". Now, these are general comments that are subject to the interpretation of those aking them which might not match up to how we might view the same evidence if we had access to it, I suspect we would reach a similiar conclusion if we did have that access. What we do not know yet is if things are going well or really , really well. The tone of the comments skewed towards the really, really well side of the equaution but that is not untypical for a meeting at this stage of the process where the data is not yet available for public review. Management teams are not meant to focus on the negatives in such situations,so you have to keep that in mind.
Obviously, we are now quite close to the phase 1a ending and Christian reiterated that he does not expect any issues with the final patients at the 300mg dosage level. When TH PR's the trial is over, it is likely going to be a content poor release such as, "the trial was successful, the drug is safe at the 300mg level and we will be using that as the MTD". Probably not much more than that. Any interesting data from the phase 1a trial will likely be held for the AACR conference at the end of June. I would imagine they are angling for a late breaker slot at this conference and will therefore need to keep any interesting data quiet until then. That is frustrating for weary investors like ourselves but this is how things are done in this world.
I inquired about side-effects and how they might differ from the normal side-effects when patient take docetaxel now (which include all the normal ones you would expect - pain, nausea, hair loss). Christian indicated while some of these were seen with TH-1902, I got the impression it depended on the patient and he suggested it may have had more to do with the patient's treatment history than with TH-1902. He said something about TH-1902 not getting into the bone marrow like other chemo does and therefore its side-effect profile is better (please realize that I may not be getting all of this perfectly correct but it should be pretty close to what was said). He reiterated that they hope they can treat patients with up to ten cycles of treatment of TH-1902 due to better side-effect profile. From looking on the interenet, it seems normal docetaxel tretaments normally have to stop after 3-4 cycles due to cumulative toxiciity. That cumulative toxicity is much lower for TH-1902 thereby allowing more treatments. Obviously, that is a big positive if it proves out in future trials and TH-1902 is also shown to be effective.
Phase 1b will be starting soon and they are looking to add 5 sites in the US and 6 in Europe. The European sites will not start up until July as it takes longer to get them going. They expect the trial to finished recruiting in the first quarter of 2023. But they will file protocol amendments to pursue a larger trial in a specific cancer type whenever they see early signs of preliminary signs of efficacy. They cannot scientifically make such a claim of preliminary efficacy signals until after the second scan. The first scan is done six weeks after the first treatment and the second one six weeks after that and they would need more than one patient showing benefit from the drug to file a protocol amendment. So, if the trial gets started in late May and they need three months and multiple patients showing benefits, the first protocol amendment, if justified by the results, will likely be seen at the earliest in September. Also, they can file multiple protocol amendments. In the case of the phase 1b, if they see preliminary signs of efficacy, that will be PR'ed as soon as they see it. So, there will be no need to wait for the phase 1b to finish sometime next year to get results if there are results.
On those results, if they see 15%-30% impact on the tumors, that is enough for FDA approval. If there is an effect that is better than 30%, then we are looking at a BTD and a faster ride through the approval process.
I am not sure if they would file multiple protocol amendments if they were fortunate to see preliminary efficacy in multiple cancer types. They indicated the Immunonmedics model is the one they are focused on, which is where you do all you can to get the first cancer type approved and then sell out to a larger pharma who will pay an unusually high price for the opportunity to chase down the rest of the cancer types on the Sort1+ platform. Obviously, if preliminary signs of efficacy are seen in multiple cancer types in the phase 1b, things will start to get pretty exciting around THTX's stock price. You will recall that Immunomedics was bought for $21 billion by GILD, a price that equates to over $200 per THTX share for those who want to dream about such a scenario at this very early stage.
Paul also brought up that the Chairwomen served on the board of Medivation, which was acquired by Pfizer for $12 billion for a prostrate drug.
Basically, the message I heard on cancer was all very positive. They made no attempt to squelch expectations. They indicated they know the stakes are very high to get cancer right and they are doing all they can to "play by the book" so they do not mess this potentially sizable opportunity up. Every decision the company has made recently suggests they have something important in TH-1902 annd that the phase 1a trial has given them confidence about its future development. If that is right, then we are all going to be happy eventually. The only question is how happy. Will TH-1902 get that BTD because it is shown to be highly effective and safe? Or will it just be another decent cancer drug among many others? Time will tell, but TH-1902 definitely has a chance to be something special and we will likely know more about those chances before the year is over.
I will have more later.