Biopharmaceutical group Hemogenyx Pharmaceuticals plc (LSE: HEMO) confirmed on Wednesday that the third patient in its Phase I clinical trial of HG-CT-1 CAR-T therapy for relapsed/refractory acute myeloid leukaemia (AML) has successfully passed initial safety evaluation.
The treatment was well tolerated and met the trial's predefined safety criteria. Early signs of efficacy were observed, with standard testing showing no detectable AML cells in the patient following treatment. The patient will continue to be monitored under the FDA-approved protocol to assess secondary endpoints, including response rates, survival and durability of treatment.
Safety data from the first three patients at the lowest dose will now be reviewed by an independent Data Safety Monitoring Board to determine whether dose escalation can proceed.
HG-CT-1 is being tested in a dose-escalation Phase I trial designed to evaluate safety and tolerability, while also collecting long-term efficacy data.
Hemogenyx is developing new treatments for blood and autoimmune diseases through a pipeline of product candidates and platform technologies.
Roivant to announce Q3 2026 financial results
HUTCHMED reports positive Phase III results for sovleplenib in wAIHA
Physiomics secures follow-on UK contract for Phase 2 study support
Amgen's UPLIZNA receives US FDA approval
Physiomics secures new contract with Numab Therapeutics for preclinical antibody development
InduPro secures strategic investment and collaboration with Sanofi to advance autoimmune therapy
Innovent Biologics reports first participant dosed in Phase 1 trial of IBI3011
AstraZeneca to invest USD2bn in major Maryland manufacturing expansion
European Commission approves Celltrion's Remsima IV liquid formulation
TIRmed Pharma partners with Bachem to advance production of atopic dermatitis therapy
Fondazione Telethon reports positive opinion for Waskyra marketing authorisation in Europe
Vascarta and CUNY report positive preclinical results in glioblastoma treatment