TGA approves trial for first-in-human multiple myeloma therapy

Australia’s Therapeutic Goods Administration (TGA) has approved a first-in-human trial of a T-cell therapy in multiple myeloma. 

The therapy, developed by HaemaLogiX in collaboration with the Peter MacCallum Cancer Centre (Peter Mac), is a KMA.CAR T-cell immunotherapy. The novel autologous CAR-T cell therapy targets Kappa Myeloma Antigen (KMA), a receptor found only on the surface of myeloma cells and not on healthy immune cells.  

This tumour-specific targeting means that, unlike currently approved BCMA-directed CAR-T therapies, KMCAR T-cell is not expected to damage healthy immune cells, potentially offering patients an effective treatment without affecting their natural ability to ward off infection. 

KMCAR T-cell therapy, developed with HaemaLogiX’s KappaMab antibody technology, harnesses the patient’s own T cells and genetically modifies them to recognise and destroy cancerous plasma cells that express KMA.  

Figures show multiple myeloma is the second most common blood cancer worldwide, with estimations from the World Health Organization (WHO) and Global Cancer Observatory (GLOBOCAN) suggesting approximately 188,000 new cases of multiple myeloma are diagnosed each year globally. Data shows 42% of patients die from the disease within five years of diagnosis. 

“Peter Mac’s Centre of Excellence in Cellular Immunotherapy is world-class and has been instrumental in bringing CAR-T therapies from the laboratory to patients,” said Dr Rosanne Dunn, Chief Scientific Officer and Founder of HaemaLogiX. 

“We are incredibly fortunate to have such a partner to translate our KMA targeting technology into the CAR-T modality. 

 “For patients with multiple myeloma who have failed or relapsed on their current treatment, it is critical that we explore novel therapeutic targets. The KMA target is unique – it is expressed on malignant plasma cells but spares normal immune cells.  

“Through the CAR-T approach, we have an opportunity to harness this tumour specificity to potentially deliver meaningful benefits for patients without harming their immune system.” 

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