Heidelberg Pharma Advances into Cohort 7 in Phase I/IIa Study for Multiple Myeloma Treatment

HDP-101, Heidelberg Pharma's lead ATAC candidate, has shown promising results in the treatment of relapsed or refractory multiple myeloma, advancing into Cohort 7 of a Phase I/IIa dose escalation study. The study has demonstrated that HDP-101 is well tolerated, with no dose-limiting toxicities detected in Cohort 6, which included 10 patients dosed at 90 µg/kg. The Safety Review Committee recommended moving into Cohort 7 with an escalated dose above 100 µg/kg, employing different split dosing strategies, including additional premedication in one arm.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, highlighted the positive impact of adapted dosing strategies on limiting platelet count reduction observed in previous cohorts. This advancement allows for further dose escalation, with the first patients of Cohort 7 already dosed. The company anticipates publishing efficacy and additional safety data from this patient group at scientific conferences in 2025.

The ongoing Phase I/IIa clinical study is a non-randomised, open label study enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA. It aims to assess the safety, tolerability, pharmacokinetics, and efficacy of HDP-101. Clinical data from Cohort 5 revealed complete remission in one heavily pre-treated patient, who showed an objective improvement in the 2nd cycle of treatment and sustained response for over a year after the 11th cycle. Other patients also demonstrated biological activity and objective responses, underscoring HDP-101's potential as a promising treatment option.

Heidelberg Pharma is pioneering the use of Amanitin, a compound from the green death cap mushroom, in cancer therapy through its ATAC technology. This innovative approach combines the specificity of antibodies with the efficacy of toxins to target and kill diseased cells, offering new hope for patients with malignant hematologic and solid tumors.