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

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CAR-T in multiple myeloma

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.” 

 

 

 

 

The post TGA approves trial for first-in-human multiple myeloma therapy appeared first on Drug Discovery World (DDW).

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STAT+: Updated: Tracking RFK Jr.’s promises to remake health in America

Updated June 11, 2026

WASHINGTON — A pledge to “Make America Healthy Again” earned Robert F. Kennedy Jr. his job atop U.S. health agencies a year and some change ago. He’s now had the opportunity to turn his words into action, with mixed results.  

“All one needs” to prove the health secretary’s attentiveness is to “review my unprecedented list of accomplishments on a wide range of issues, all of which I drove,” Kennedy posted on X on Wednesday in response to a journalist.

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Updated June 11, 2026

WASHINGTON — A pledge to “Make America Healthy Again” earned Robert F. Kennedy Jr. his job atop U.S. health agencies a year and some change ago. He’s now had the opportunity to turn his words into action, with mixed results.  

“All one needs” to prove the health secretary’s attentiveness is to “review my unprecedented list of accomplishments on a wide range of issues, all of which I drove,” Kennedy posted on X on Wednesday in response to a journalist.

Continue to STAT+ to read the full story…

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An obesity drug deep-dive, and peptides move mainstream

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Can any of the new obesity medications in development stand out from the pack? Which company just broke records with its IPO? And will the Food and Drug Administration allow greater access to experimental peptides?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

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RFK Jr. claims his calendar is publicly available. We’ve been trying to get it for a year

WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

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WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

Read the rest…

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