RE: Hemo Going Forward3 Nov 2025 07:26
Brilliant post below from Haywain yesterday
Just reading through the weekend dribble from the usual suspects. You cant analyse HG-CT-1 through the lens of normal because it clearly isn't. "Normal phase 1" , Normal DSMB processes", "Normal Pharma behaviour". But HG-CT-1 is quietly breaking every convention that has defined AML therapy for the last two decades. Patient 1 with FLT3 positive r/r AML - probably multiply refractive to front line treatment (means previous treatments failed) to be selected as patient 1 - HG-CT-1 represented last hope. After a 1/2 single dose of HG-CT-1, P1 was still in remission at 6M post treatment per the recent RNS without HSCT, no transfusions, no cytopenias, no CRS, no ICANS (recognised dose limiting toxicities) and are still (as far as we know) doing well. In this indication FLT3 +ve r/r AML without HSCT patients Usually relapse very quickly - within weeks to a couple of months without HSCT. If they are lucky enough to be able to tolerate HSCT the medial overall survival is 6-9 months in this indication. Similar story in patient 2 (6M post treatment) and an " undetectable by conventional analytical methods" result within the safety window for patient 3 - ie laymans speak for MRD-ve. In this disease the leukaemic progenitors reseed relapse unless those progenitors are cleared then relapse is inevitable. FLT3 (the target) is highly expressed in the leukaemic progenitors but poorly expressed in the normal HSC compartment and it is this differential that HG-CT-1 is uniquely designed to exploit. By design HG-CT-01 was created to selectively kill bulk blasts expressing FLT3 aswell as the FLT3 expressing leukaemic progenitor compartment whilst sparing normal HSC's and the results appear to support that it is achieving exactly this no dose limiting cytopenias (which have been seen in all other AML CAR-T's to date) and durable remissions. If it has truly achieved what it was designed to do, we are looking at a potentially curative CAR-T therapy in a space where standard-of-care outcomes are dismal. That is, by definition, not "normal". This is precisely why I expect pharma to move well before the “normal” timelines. Once this kind of data becomes public, competition will drive urgency hence my comments around DSMB decision arriving at the deadline for ASH late breaking submission. For now the right people already have access to the true underlying data through non-disclosure agreements and that’s exactly how these discussions are meant to unfold at this stage.
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