Aussie CAR-T patients die waiting

17 March 2021

While more than 80 Australian cancer patients were treated with life-saving CAR-T in Australia last year, a significant number of other patients died due to an inability to access a clinical trial, the head of Cell Therapies has revealed.

The company’s Chief Scientific Officer and interim CEO, Associate Professor Dominic Wall, told a BioMelbourne Network event on Tuesday that disruptions to overseas trial sites and overseas travel restrictions meant many Australians died.

“I’ve lost count of the number of phone calls I’ve had from patients who wanted access to a trial which we could not provide to them,” he said.

“They couldn’t leave the country. The trial sites in North America were wiped out by Covid and inevitably, all of these patients died.”

Ass Prof Wall said Australian patients “did face quite substantial delays in trying to get access to this type of technology” as the process is dependent on thousands of internationally manufactured components.

“You can only imagine what happened in March, June and July last year when one could barely get a flight for love nor money from the West Coast into Australia and vice versa,” he said.

“Fortunately our pharmaceutical sponsors did an amazing job in assuring a certain level of manufacturing but there were patient delays.

“Whilst I can’t speak specifically to the Australian experience, I am well aware that in other jurisdictions, a significant number of patients who were waiting for treatment died waiting for those treatments to be made.”

Singapore a growing threat

Ass Prof Wall also warned Singapore had used the pandemic to try and oust Australia as the designated CAR-T manufacturing hub for the Asian Pacific region, as it offered a Covid-safe “bubble” where flights continued going in and out.

“Singapore has been trying and will continue trying to do everything possible to move this technology to its shores,” he said. “There is fearsome government-led interventions when it comes to global responses to high-technology manufacturing in cell and gene.

“Australia has, to some extent, stumbled into a winning position and is essentially facing some pretty coordinated competition.”

Ass Prof Wall said lack of air transport security had been crushing for Cell Therapies, which was required to carry “ridiculous amounts of stock, as all of our clients demand, and this depletes our working capital”.

“Even now there are markets and opportunities we can’t support because of transport insecurity. This doesn’t mean opening borders. It means having a predictable flight that can take air freight in or out. I think it will be a major risk for sovereign manufacturing in cell and gene because other markets are now saying they can support the Asia Pacific better than Australia.”

He stressed the role of local manufacturing was not to support the Australian market but the region.

“There is absolutely no doubt that a lot of the interest that comes from our international clients is about supporting the regional opportunity as the Australian market in itself is not particularly exciting. The real market opportunities are in South East Asia but also in Japan.”

Challenges and opportunities

The ‘BioBriefing – Strengthening Sovereign Capabilities: Advanced Manufacturing for Australian BioPharma’ event heard about the challenges and opportunities for greater sovereign manufacturing in Australia, with Ass Prof Wall adding Cell Therapies had endured 25 TGA contract manufacturing inspections as the regulator required individual product approvals rather than a class approval”.

He said the US had now approved three CAR-T products and while Australia had approved two, “only one is currently reimbursed”. Gilead’s YESCARTA was approved in January 2020 but a pricing deal has still not yet been struck enabling reimbursed access.

“But the fact is there is a tidal wave of new products,” he said, later adding, “if you don’t have the means of production, you are writing yourself out of the future”.