Posted On: 18 Jun 2026
Sydney, Australia, 18 June, 2026 - HaemaLogiX Ltd, a clinical-stage biotech developing novel immunotherapies for patients with blood cancers and B cell diseases, is pleased to announce that it has received approval from the Human Research Ethics Committee (HREC) at the Alfred Hospital Ethics Committee (Bayside Health) for the Phase 2b clinical trial of its lead asset, KappaMab™.
The approved study - HLX-KM-04 - titled: “A Phase 2b, Open Label, Dose Optimisation Study of the Safety of Multiple Doses of Single Agent KappaMab™, and the Safety and Efficacy of Multiple Doses of KappaMab™ plus Pomalidomide and Dexamethasone in the Treatment of Kappa Restricted Multiple Myeloma Patients with Relapsed Disease,” represents a key milestone in the continued clinical advancement of KappaMab™.
The approval allows the lead clinical site, The Alfred Hospital, to initiate patient enrolment once funding for the trial is finalised. The trial 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, Australia.
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.”
Dr Rosanne Dunn, Executive Director and Chief Scientific Officer of HaemaLogiX, said: “This Phase 2b study represents an important next step in understanding the full therapeutic potential of KappaMab™. By exploring higher dosing and combination treatment strategies, we aim to build on the favourable safety profile observed to date and evaluate its ability to improve survival outcomes in patients with relapsed multiple myeloma with an unmet clinical need.”
About KappaMab™ and this Phase 2b study
KappaMab™ targets the Kappa Myeloma Antigen (KMA) - a tumour-specific receptor found only on myeloma cells and absent from healthy immune cells. This unique specificity has the potential to deliver effective tumour killing, while sparing normal immune function, distinguishing KappaMab™ therapy from currently approved BCMA-directed CAR-T therapies.KappaMab™ is at an advanced stage of development, with positive results demonstrated in prior Phase 1, 2a and 2b trials. HLX-KM-04 is expected to enrol up to 42 patients, and will evaluate a higher dosing regimen of 30 mg/kg (compared to 10 mg/kg in the previous Phase 2b), as well as assess the safety and efficacy of KappaMab™ in combination with standard-of-care therapies Pomalyst® (pomalidomide) and dexamethasone in patients with relapsed kappa-restricted multiple myeloma.
About Multiple Myeloma
Multiple myeloma is a blood cancer arising from plasma cells in the bone marrow. Despite significant advances in treatment, most patients eventually relapse and become refractory to available therapies.
Multiple myeloma is the second most common haematological cancer worldwide. In 2022, the World Health Organisation (WHO) Global Cancer Observatory estimated that approximately 543,000 people were living with multiple myeloma globally[2], with around 188,000 new cases diagnosed annually and approximately 121,400 deaths each year[3]. Approximately 42% of patients die within five years of diagnosis. In Australia, multiple myeloma is the most expensive cancer to treat on a per person basis[4].
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