HaemaLogiX presents important new pre-clinical data at EHA2024 in Madrid

HaemaLogiX is delighted to be sharing the results of new pre-clinical data at the European Association of Hematology Congress, EHA2024, taking place this week in Madrid, Spain. This important event highlights our commitment to advancing the treatment of haematologic conditions through innovative research.

Engaging with the global haematology community

CEO/Managing Director Damian Clarke-Bruce and CSO/Executive Director Dr. Rosanne Dunn will engage with potential partners and collaborators on the topic, "Solving the Unmet Need in AL Amyloidosis: KMA and LMA - Novel Antigens on the Surface of Aberrant B Cells." Their presentation will focus on our novel approach to addressing AL amyloidosis, a rare and serious condition caused by abnormal protein deposits in tissues and organs.

Publication and presentation

New pre-clinical data has been published in:

·  The congress' online Abstract Book, a supplement of HemaSphere (EHA’s official journal)

·  The EHA Library, and

·  The Congress platform.

The publication, authored by Aintzane Zabaleta1, Mary Sartor2, Ramón Lecumberri Villamediana3, Rosanne Dunn4, David Gottlieb2, 5, and Jesús San Miguel3, is titled "Novel Antigens LMA and KMA Are Expressed on Bone Marrow Plasma Cells from Patients with AL Amyloidosis but They Are Not Detected on Normal Plasma Cells."

Speaking about the Congress publication, CSO and Executive Director, Dr Rosanne Dunn commented, “This work has been conducted together with Professor Jesus San Miguel at Clinica Universidad de Navarra and his team here in Spain, and with our research collaborators at the Westmead Institute for Medical Research led by Professor David Gottlieb and his team.

These data have shown that 100% of amyloidosis patient bone marrow plasma cells express either LMA or KMA. An interesting observation in this study is that these targets - both KMA and LMA - are still present after treatment with daratumumab in combination with other standard-of-care agents, which are approved for first-line treatment of AL amyloidosis. This indicates that our HaemaLogiX immunotherapies could be used to treat patients who are not responding to daratumumab.

The results of this study in amyloidosis support our published myeloma data, showing that LMA and KMA define treatment-resistant, disease-causing plasma cells - and our published KappaMab Phase 2b clinical results have shown that our immunotherapies can deplete these persistent aberrant cells without affecting normal immune cells. These new data are very encouraging and strongly support our immunotherapeutic approach in amyloidosis and myeloma.”

Key findings from the research

Our research presents several critical findings:

• Specific expression: novel antigens LMA and KMA are expressed on bone marrow plasma cells from patients with AL amyloidosis but importantly, they are not detected on normal plasma cells.

• High expression rates: all samples (100%) expressed LMA (n=23) or KMA (n=8), as well as BCMA (n=30). LMA and KMA were detected on CD38-positive cells in all six patient samples (100%) treated with daratumumab.

• Higher antigen densities: the range of antigen densities was higher for LMA and KMA compared to BCMA.

• Drug-mediated effect: the decrease in CD16 expression in the cell lysis assays indicates an antibody-mediated effect, potentially through NK cell activation.

• Therapeutic potential: the combination of increased and persistent antigen density following standard-of-care therapies, along with the specificity of these therapeutic antibodies, suggests these therapeutic antibodies could open new therapeutic options for patients with AL Amyloidosis.

CEO's insight

CEO/Managing Director Damian Clarke-Bruce commented, "This research reinforces earlier findings that our novel antigens, KMA and LMA, are predominantly found on malignant plasma cells. This offers a new clinical pathway for addressing AL amyloidosis, multiple myeloma, and some autoimmune diseases.

"Through this EHA publication and our congress attendance, we are pleased to have the opportunity to share our work on the global stage with potential collaborators and partners. Our thanks go to the paper's co-authors, each of whom are highly regarded, who share our hope that these discoveries may bring new therapeutics for patients in need."

Access the full research

For those interested in exploring our findings further, a copy of the publication can be found here, and the presentation is available here.

Conclusion

HaemaLogiX remains dedicated to pushing the boundaries of medical research to develop innovative treatments for haematological conditions. Our participation in EHA2024 underscores our commitment to addressing unmet medical needs and enhancing patient outcomes.

We look forward to sharing more updates from the congress via our social media channels.

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Author affiliations:

1  Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de

Investigación Sanitaria de Navarra (IDISNA), CIBERONC, Pamplona, Spain

2   Westmead Institute for Medical Research, Centre for Cancer Research, Westmead, Australia

3   Clinica Universidad de Navarra, Hematology and Hemotherapy Service, Pamplona, Spain

4  HaemaLogiX Ltd, Clincial Operations, Woolloomooloo, Australia

5   Westmead Hospital, Department of Haematology and Bone Marrow Transplantation, Westmead, Australia