Australian biotech HaemaLogiX is planning to initiate another Phase IIb trial with a higher dose of KappaMab in patients with multiple myeloma, chief scientific officer Rosanne Dunn told Clinical Trials Arena.

The company expects to initiate the trial early next year.

KappaMab is a monoclonal antibody that targets the kappa myeloma antigen (KMA) found on the surface myeloma cells in kappa-type myeloma.

The Phase IIb study will investigate a 30mg/dose of KappaMab. The trial will start off with a safety run-in period, and then Kappamab will be administered in combination with pomalidomide and dexamethasone.

Dunn explained that the rationale behind this combination is that pomalidomide increases the density of the targets on the surface of myeloma cells.

The biotech expects to enrol 36 patients who had one to three lines of treatment, including those treated with Bristol Myers Squibb’s Revlimid (lenalidomide).

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HaemaLogiX will consider including a cohort of patients previously treated with Johnson & Johnson’s Darzalex (daratumumab). However, this will depend on the patient population, as Darzalex is not extensively used in Australia, Dunn said.

Initially, the biotech will open sites in Australia but plans to expand the trial to other countries. HaemaLogiX has already identified sites in Europe and the US, said Dunn. The trial will measure overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).

Phase IIb results with a lower dose of KappaMab

In June, HaemaLogiX reported the final results from a Phase IIb study (ACTRN12616001164482) that investigated 10mg/kg of KappaMab alone and in combination with Revlimid and dexamethasone.

The key findings showed that the combination treatment achieved ORR of 83% compared to the matched case-control group which achieved an ORR of 45%.

Additionally, the treatment combo demonstrated a significant OS advantage, with a 46% reduction in the risk of death.

HaemaLogiX’s further pipeline

In July, HaemaLogiX announced a collaboration with Peter MacCallum Cancer Centre (Peter Mac), an Australian oncology research institute. Together, they will initiate a first-in-human Phase I trial investigating immunotherapy KMA.CAR-T in kappa-type multiple myeloma.

Under the agreement, HaemaLogiX will bring its patented KappaMab technology while Peter Mac will be responsible for developing the technology, manufacturing and the conduct of the trial. The trial is expected to start early next year and recruit up to 12 patients who have failed three classes of drugs.

While KappaMab targets kappa-type myeloma, KappaMab also has antibodies that target lambda-type myeloma in its pipeline. Dunn noted that the biotech is currently conducting preclinical studies and intend to start LMA CAR-T cell trials in the near future.

HaemaLogiX’s executive director Alan Liddle added that the biotech also has early work in the area of B cell-related autoimmune diseases. However, HaemaLogiX is currently focusing on upcoming clinical trials and will look at developing assets for other B cell indications at a later date.