Pharma aims to deliver personalized cancer therapies more quickly
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[July 24, 2024]
By Michael Erman
NEW YORK (Reuters) - Big pharmaceutical companies that make personalized
blood cancer treatments are working to cut the manufacturing turnaround
time by as much as half in coming years, as they try to deliver them
sooner in a patient's disease course.
These treatments known as CAR-T therapies are used for the sickest
patients for whom standard treatments have failed. They involve removing
a patient's T cells - a key component of the immune system - after which
they are re-engineered to recognize and attack malignant cells once they
are re-infused.
Gilead Sciences, Novartis, Johnson & Johnson, and Bristol Myers Squibb
have made billions from their treatments, which can extend lives by
months or years for patients with aggressive advanced cancers.
Trimming days or weeks from the time it currently takes between removing
and reintroducing the cells to a patient could open the treatment to
those who otherwise would become too sick during the process, according
to three doctors, the companies and analysts.
Prices for the one-time treatment range from $400,000 to nearly
$600,000, and analysts estimate they currently have profit margins of
about 50%, so expanding the patient population is not insignificant.
Oppenheimer & Co analyst Hartaj Singh said only around 1 in 5 eligible
patients receive CAR-T treatments.
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"It's complex manufacturing using the patient's own cells, but because
some of the responses reported are just so long and durable, physicians
will go to it," Singh said. "It's the biggest gun out there."
Time to treatment, which was as long as 37 days when the first CAR-T
therapy was launched in 2017 by Novartis, are now down to 14 days at
Gilead. Improvements in automation and regulatory adjustments could help
companies further trim that time.
Singh said physicians suggested to him that a one-week turnaround could
expand these treatments to 2 or 3 out of 5 eligible patients.
Improvements in manufacturing time could be a competitive edge when
therapies are approved for the same cancer or population and directly
compete, and could give companies a leg up on more quickly available
treatments such as antibodies or antibody drug conjugates, he added.
To make the treatments, a patient's T cells are isolated, frozen and
shipped to manufacturers. Once received, the cells are purified,
modified and expanded to large enough numbers to treat the patient. They
then go through quality control processes before being re-frozen and
shipped back for infusion.
Gilead is testing new technology it hopes can cut two days from the
manufacturing process by using healthier and more potent younger cells.
The company is also looking to fully automate some parts of
manufacturing that are now semi-automated and gain regulatory approval
to shorten the quality control time.
Novartis is aiming for 10 days or less in the U.S. for its next
generation of treatments through its rapid manufacturing platform
T-Charge. Its treatment, Kymriah, currently takes 3 to 4 weeks with a
target of 22 days.
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![](../images/072424PIX/health5.jpg)
Cindy Perettie, Executive Vice President of Kite, poses for a
portrait at Gilead unit Kite's manufacturing facility in Frederick
Maryland, U.S., March 14, 2024. REUTERS/Leah Millis/File Photo
![](http://archives.lincolndailynews.com/2024/Jul/24/images/ads/current/guzzardos_lda_GENERIC_040524.png) Novartis said the T-Charge system
would shorten the manufacturing time because it allows for the
engineered cells to multiply within the patient, reducing the need
for extended cell expansion before infusion.
'EVERY DAY MATTERS'
Dr. Chijioke Nze of MD Anderson Cancer Center in Houston said a
manufacturing time of a week would be ideal.
Frailer patients can develop kidney or liver dysfunction while they
wait for their therapy to be manufactured or may become too weak to
be able to successfully undergo treatment, Nze said. He has
prescribed Gilead's Yescarta and Tecartus as well as Bristol Myers'
Breyanzi.
"The patient population that needs CAR-T cell therapies generally
have the more aggressive of an already aggressive disease," he said.
Analysts and drugmakers say using CAR-T drugs earlier before doctors
first prescribe multiple other treatments that fail to help patients
would also expand use. J&J’s Carvykti, for example, was approved in
April for patients who did not benefit from just one other treatment
for multiple myeloma.
Some CAR-T approvals require patients to receive three or four other
treatments to fail before using the therapy.
Increasing the number of hospitals and health centers offering the
treatments also will make it feasible for more patients, they said.
Since 2017, over 42,000 people globally have received CAR-T
treatments. Six are approved in the U.S. for the treatment of blood
cancers, including lymphomas and some forms of leukemia.
Lynelle Hoch, who leads Bristol Myers Squibb's cell therapy
business, said its current focus is on increasing manufacturing
capacity. Still, it said its time to produce the treatments is
trending lower and will be helped by its collaboration with Cellares,
a development and manufacturing organization with a fully automated
cell therapy production platform.
J&J in a statement said it doubled its CAR-T manufacturing capacity
last year and is striving to double it again in 2024. It said it is
working to further reduce treatment times.
Cindy Perettie, an executive at Gilead's Kite cell therapy unit,
said in an interview that lymphoma patients who have already tried
two treatments generally only have months to survive and need to get
treated as quickly as possible.
"Every day matters for these patients.”
(Reporting by Michael Erman; Editing by Caroline Humer and Bill
Berkrot)
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