Heidelberg Pharma has reported encouraging progress in its phase 2/2a trial of HDP-101 (INN: pamlectabart tismanitin), its lead ATAC candidate for relapsed or refractory multiple myeloma.
The company confirmed that two patients in cohort 8 achieved stringent complete remission (sCR), with no detectable tumour cells in blood or bone marrow.
Seven patients were evaluated at a dose level of 140 µg/kg. All showed a favourable safety and tolerability profile, with no dose-limiting toxicities observed. Four patients demonstrated biological activity, including one partial response, one very good partial response and two sCRs.
Dr András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “We are very delighted by the data seen so far. Several patients across different cohorts have shown objective responses and promising anti-tumor activity. Observing two stringent complete remissions is an encouraging validation of our therapeutic approach.”
He added: “We have previously seen complete remission in one patient from Cohort 5, but in Cohort 8 onset of the response was more rapid.
These findings further strengthen our confidence in the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma, and we are now progressing with Cohort 9 with an escalated dose of 175 µg/kg to continue its clinical evaluation.”
The phase 2/2a study is a non-randomised, open-label, dose escalation trial enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. It aims to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HDP-101.
