Clinical-stage company HaemaLogiX, which is developing novel immunotherapies for blood cancers and B-cell diseases, has received approval from the Alfred Hospital Ethics Committee Bayside Health for the Phase 2b clinical trial of its lead asset, KappaMab.
The approval permits the lead clinical site, The Alfred Hospital, to begin patient enrolment once trial funding is finalised.
The study will be led by Principal Investigator Professor Andrew Spencer, MD, Head of the Malignant Haematology Transplantation and Cellular Therapy Service at The Alfred Hospital in Melbourne.
The company said HLX KM 04 is expected to enrol up to 42 patients and will evaluate a higher dosing regimen of 30 mg/kg compared with 10 mg/kg in the previous Phase 2b, while also assessing the safety and efficacy of KappaMab in combination with standard-of-care therapies pomalidomide and dexamethasone in relapsed kappa-restricted multiple myeloma.
Dr Chris Baldwin, CEO and Managing Director of HaemaLogiX, said, “Receipt of ethics approval for our KappaMab Phase 2b clinical trial in combination with pomalidomide and dexamethasone is a significant milestone for HaemaLogiX. I want to thank Bayside Health, Professor Andrew Spencer and his team at The Alfred Hospital, and Dr Rosanne Dunn and her team for all their efforts, which have enabled us to reach this critical point.
“We are actively progressing funding initiatives to support the timely execution of this important study. This, alongside the recent opening of enrolment for the KMCAR™ T cell clinical trial at Peter MacCallum Cancer Centre demonstrates that HaemaLogiX is tightly focused on gathering new data on its therapies in multiple myeloma. These studies will not just improve our understanding of specific assets, but will enable subsequent pivotal programs across emerging therapeutic approaches as well.”
KappaMab targets the Kappa Myeloma Antigen (KMA), a tumour-specific receptor found only on myeloma cells and absent from healthy immune cells. Its tumour specificity may enable effective tumour killing while sparing normal immune function, thereby distinguishing KappaMab therapy from currently approved BCMA-directed CAR T therapies. KappaMab has shown positive results in prior Phase 1, 2a, and 2b trials.
