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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.”
The post TGA approves trial for first-in-human multiple myeloma therapy appeared first on Drug Discovery World (DDW).
BioNTech, in a move to streamline its operations, is set to close its factory in Singapore that it bought from Novartis just over three years ago.
The facility at the Tuas Biomedical Park, which employs …
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STAT+: Merck’s experimental HIV prevention pill could be made for less than $5 a year, researchers say
An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.
The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.
Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.
An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.
The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to ClinicalTrials.gov.
Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.
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Opinion: STAT+: Former Geisinger CEO: U.S. health systems must replace huge numbers of people with AI
About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians.
Only a fraction of the people in that room were clinicians.
That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate.
About 20 years ago, I stepped on stage at one of our Geisinger town halls and looked out upon a sea of people: thousands of full-time employees at an integrated health system charged with the health and well-being of millions of Pennsylvanians.
Only a fraction of the people in that room were clinicians.
That was the first time I fully visualized the problem: We employed more people in our revenue cycle department to process bills and reconcile data than we did doctors. And we weren’t alone. It’s the same story at every health system in America, large and small, and over the past two decades, the ratio has become dramatically more disparate.
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