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GSK signals new direction

Posted 12 August 2019

GSK has signalled a shift in its regulatory activities towards cancer and new generation therapies including cell and gene-based treatment. 

A job notice the company posted for a regulatory affairs position revealed it is planning to add to its traditional respiratory and vaccines therapeutic areas, planning future batches of applications and filings around new generation medicines in oncology and immunology.

"Currently we are registering medicines in the areas of HIV, immunotherapy, respiratory and vaccines," the notice said. 

"However, we are now moving into an exciting phase our pipeline and focus which is immuno-oncology and immune-inflammation, involving immunotherapy, cell therapy and gene therapy. The successful candidate for this role will be working on the strategic direction and applications for our new medicines in these exciting areas."

The company's callout for the regulatory affairs role also asks for expertise in immunology or oncology. 

Globally the company has made a definitive move towards new generation cancer and gene therapies, reflecting a general trend in the industry. 

It acquired cancer biotech Tesaro last year for USD5.1 billion, gaining ownership of its PARP inhibitor Zejula, although in Australia the drug is being sponsored by Takeda. 

But the Tesaro buyout also added PD-1 inhibitor dostarlimab to GSK's pipeline. The drug TSR-042 is in a pivotal phase 2 trials for endometrial cancer. 

Meanwhile in February GSK acquired rights to another PD-1 drug bintrafusp alfa from Merck KGaA in countries outside the US. The drug is also in a pivotal phase 2 trial for biliary tract cancer, while the company is overseeing other mid-stage trials including a head-to-head with MSD's Keytruda in NSCLC.

In immuno-inflammatory disease the company has a late stage candidate otilimab which it is testing as a treatment for rheumatoid arthritis. 

It also has two cell therapies in phase 2 trials for cancer, including a SPEAR T-cell cancer therapy it acquired from Adaptimmune. 

Yajun Ma

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