Our CORE-NK trial at Case Western, is a multi-arm trial aiming to study 12 patients. At the time of the readout in late October, there were 3 patients enrolled. One Complete Response was reported in a patient with AML, This is the statement from the ann:-
So, as Krushingit infers, 1 out of 1 or 100% ain't to be scoffed at for success in AML, and in a time-frame of just 28 days. Sure, it is only one patient with AML that has been tested... but it is the first and only patient to be tested... and we got a CR. Its important to keep in mind that Phase 1 studies primarily establish whether the therapy is safe. We get a tick on that front with the added bonus of the ultimate efficacy of a CR within a period of just one month! This is subsequent to an AML patient who has now been cancer free for 48 months on the Phase 1 study!
However, that leaves 2 patients in Phase 1b solid tumour arm who were enrolled. What are their results? Vactosertib has success in its independent trials in colorectal cancer. Based on the trial information on the official clinical trial site, it suggest that we have 2 patients with colorectal cancer in our current trial. Why did we not receive a readout on their results? Were they not at the 28-day mark at the time of the readout in late October perhaps, OR is the dose of Vactosertib too low in our particular trial to derive clinical activity as early as 28 days? The FDA requires new combination therapies to be at a lower dose under an umbrella IND (such as ours) where Vactosertib has IND approval in other trials.
The trial is now recruiting patients with Gastric/Esophageal Cancer. Apparently, biotech companies don't disclose all data all the time (and, I will try to find the article/s on this subject at a later date), nor are they obliged to for reasons of confidentiality. We will probably never know what clinical activity, if any, was observed in the other two patients with Colorectal Cancer. Maybe a higher dose of Vactosertib is required to induce a clinical response or a reportable clinical response. Of course, CHM is going to report the best of the best, but who is to say that the best is or isn't yet to come?
What data and/or IP is MedPacto, Case Western and CHM each looking for in this Phase 1b study? Does CORE-NK enhance Vactosertib or vice versa, and is CHM looking primarily to prove up its platform for out-licensing OR to identify areas of interest to compliment our pipeline and/or identify areas of unmet need? Finding a niche for technologies, finding the right combinations of therapies is what biotech in immunotherapy is all about these days.
Anyway, I seem to have gone off on a bit of a tangent here. But, here's some more interesting info on Vactosertib:
Seems like a lot of comparative studies are happening on involving Vactosertib. Our trial has perhaps identified a new area in which MedPacto can leverage its drug, and we can have a piece of the pie. Its filling the gaps such as where Keytruda is not able to work but where CORE-NK cells can do their natural killing thing.
(20min delay)