US Food and Drug Administration green lights new CAR T drug

The burgeoning CAR T therapy industry has passed another significant milestone after the US Food and Drug Administration (FDA) approved Breyanzi for use in certain blood cancers called B-cell lymphomas.

The burgeoning CAR T therapy industry has passed another significant milestone after the US Food and Drug Administration (FDA) approved Breyanzi for use in certain blood cancers called B-cell lymphomas.

Breyanzi is a Chimeric Antigen Receptor T cell (CAR T) therapy initially developed by Juno Therapeutics, before being acquired by Celgene and then Bristol Myers Squibb,.

CAR T therapies work by genetically modifying a cancer patients’ T cells (part of the immune system) to identify and attack cancerous tumours.

This latest treatment is only the third gene therapy to be approved by the FDA for patients with relapsed or refractory Large B-cell Lymphomas (r/r LBCL’).

 

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens,” he further added.

 

Advancement in Australian CAR T industry 

Dr Allen Ebens – one of the senior directors who helped Juno to develop Breyanzi – is now working with Australian listed biotech company Prescient Therapeutics to develop the next generation of CAR T therapies.

Prescient Therapeutics is currently developing a platform, called OmniCAR, which will enable CAR T treatments to be administered to patients more safely than first generation treatments currently on the market.

It will also give medical professionals greater control over the modified CAR T cells, and allow them to target multiple tumours simultaneously or switch from one target to another – both features that present-day treatments lack.

The platform was built using technology licensed from both the University of Pennsylvania and Oxford University, and Prescient hope it will give medical practitioners “unprecedented control and flexibility” over current generation CAR-T therapies.

The local industry has also grown in recent weeks with the entry of a second CAR T producer, Chimeric Therapeutics, to the Australian bourse on 18 January.

 

To stay up to date with PTX company news and announcements you can register your details on their investor centre.

 

Reach Markets have been engaged by PTX to assist with private investor management.

 

Sources:

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