RE: Tatiana Schlossberg1 Jan 2026 12:18
It is precisely the outcome of the MSK trial that gives me confidence we are seeing something different with HG-CT-01. In the referenced study patients experienced on-target off-tumour effects leading to prolonged cytopenias, leaving them severely immunocompromised. As a result although 3/5 patients initially responded- they subsequently either succumbed to infection or relapsed, with two doing so within two months of treatment. All requiring HSCT to consolidate any benefit. If a similar safety profile were emerging with HG-CT-01 the programme would not have progressed as it has. The FDA’s decision to green-light paediatric dosing after just two adult patients together with DSMB approval for dose escalation following several months of follow-up would not occur in the presence of severe CRS and cytopenias. I have no doubt that detailed data will be disclosed in due course, these regulatory and safety signals suggest HG-CT-01 may be behaving in a way not previously seen with CAR-T (or any other therapy) in AML. With Patient 1 approaching 12 months post-treatment in February, clarity is not far away. Happy New Year — and here’s hoping 2026 looks very different for Hemogenyx than years past.