HaemaLogiX Announces Positive Final Results from KappaMab Combination Phase IIb Myeloma Trial

Significant improvement in Overall Response Rate (83%) compared with matched case control group (45%).

Significant overall survival advantage,with a 46% reduction in the risk of death.

Excellent safety profile and significant efficacy bolster HaemaLogiX's plan to progress further KappaMab / standard of care combination studies.

SYDNEY,June 29,2023 --HaemaLogiX Ltd,a clinical stage Australian biotech company developing novel immunotherapies for multiple myeloma,today announced positive final results from a Phase IIb clinical study of its monoclonal antibody KappaMab in combination with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatment options.

The final data has been published in the British Journal of Haematology. Key findings include:

A statistically significant overall response rate (ORR) of 83% and clinical benefit rate (CBR) of 93% in KappaMab + lenalidomide / dexamethasone (Case) was achieved compared to the matched Control cohort of lenalidomide + dexamethasone alone (ORR = 45%).

The median Overall Survival was not reached,with two patients remaining on therapy and continuing to respond,and with no evidence of detectable disease.

KappaMab's previously established safety profile was reaffirmed,with no KappaMab related haematological toxicities or serious adverse effects.

KappaMab targets a receptor called Kappa Myeloma Antigen (KMA) found only on the surface of myeloma cells in kappa-type multiple myeloma patients and not on normal immune cells,which means normal immune cells are not damaged by the treatment.

The phase IIb study was initiated off the back of phase I,IIa,and preclinical data suggesting KappaMab may have a synergistic mechanism of action with lenalidomide,a drug sold under the trade name Revlimid®,that forms standard of care for multiple myeloma. Lenalidomide is administered as both a monotherapy and with other drugs including dexamethasone,depending on the treatment approach and disease status.

"This study validates KMA as a highly specific target,and the ability to safely deliver KappaMab in combination with a mainstay treatment for multiple myeloma," HaemaLogiX CEO,Bryce Carmine,said:

"Patient response shows the combination of KappaMab with one of the most common multiple myeloma treatment approaches - lenalidomide and dexamethasone – outperforms that treatment approach alone.

"We are tremendously grateful to the investigators and to the patients who participated.

"We look forward to furthering the clinical progress of KappaMab with a clinical trial at a higher dose of KappaMab which will flow into a Phase IIb study investigating KappaMab in combination with pomalidomide and dexamethasone in patients who have relapsed or become refractory to other standard of care treatments."

This Phase IIb trial followed a Phase IIa open-label multiple dose trial to determine the safety and efficacy of multiple doses of KappaMab monotherapy in 19 relapsed and / or refractory patients who had received multiple prior treatments.

The phase IIb trial was a multi-centre trial led by Professor Andrew Spencer,which evaluated patient responses to KappaMab when combined with standard of care treatment compared to the standard of care drugs alone. The trial enrolled 40 patients with kappa-type myeloma who had previously been treated with one to three lines of drugs,and in which the disease was progressing. Along with positive efficacy results,the trial demonstrated an excellent safety profile with no patients experiencing KappaMab related serious side effects.

About HaemaLogiX Ltd -www.haemalogix.com:

Formed in 2014,HaemaLogiX is a public unlisted biotech company researching antibody therapies for multiple myeloma. Multiple myeloma is a haematological (blood) cancer of plasma cells (B cells) that can cause focused damage to a patient's bone marrow. Multiple myeloma is considered treatable but generally incurable. The HaemaLogiX team has a wide range and depth of experience in antibody research,nonclinical & clinical development,manufacturing and commercialisation. The Scientific Advisory Board (SAB) members are internationally recognised experts in monoclonal antibody therapies and haematology. Our current research and clinical trial partners are global leaders in Multiple Myeloma and AL Amyloidosis therapy. HaemaLogiX is located in Sydney,Australia.