• Ethics approval received from the Alfred Hospital Human Research Ethics Committee (Bayside Health) for Phase 2b KappaMab™ clinical trial “HLX-KM-04”
• Study will evaluate safety and efficacy of KappaMab™ at 30 mg / kg, in combination with pomalidomide and dexamethasone in relapsed kappa-restricted multiple myeloma
• KappaMab™ has been validated across Phase 1, 2a and 2b clinical trials to date, demonstrating a favourable safety profile. This Phase 2b study is designed to evaluate higher dosing levels and combination therapy to enhance clinical outcomes
• Approval enables The Alfred Hospital to commence patient enrolment pending funding,
  subsequent institutional approval and site activation
• Trial to be led by Professor Andrew Spencer, MD, a leading haematologist and myeloma specialist
• Multiple myeloma is the second most common blood cancer worldwide; more than half of patients fail standard-of-care treatment

 - 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.”