Pharma aims to deliver personalized cancer therapies more quickly
By Michael Erman
NEW YORK, July 24 (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 GILD.O, Novartis NOVN.S, Johnson & Johnson JNJ.N, and Bristol Myers Squibb BMY.N 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.
"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.
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.”
CAR-T treatments available in the U.S. CAR-T treatments available in the U.S. https://reut.rs/3WBYbwV
Reporting by Michael Erman; Editing by Caroline Humer and Bill Berkrot
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تازہ ترين خبريں
دستبرداری: XM Group کے ادارے ہماری آن لائن تجارت کی سہولت تک صرف عملدرآمد کی خدمت اور رسائی مہیا کرتے ہیں، کسی شخص کو ویب سائٹ پر یا اس کے ذریعے دستیاب کانٹینٹ کو دیکھنے اور/یا استعمال کرنے کی اجازت دیتا ہے، اس پر تبدیل یا توسیع کا ارادہ نہیں ہے ، اور نہ ہی یہ تبدیل ہوتا ہے یا اس پر وسعت کریں۔ اس طرح کی رسائی اور استعمال ہمیشہ مشروط ہوتا ہے: (i) شرائط و ضوابط؛ (ii) خطرہ انتباہات؛ اور (iii) مکمل دستبرداری۔ لہذا اس طرح کے مواد کو عام معلومات سے زیادہ کے طور پر فراہم کیا جاتا ہے۔ خاص طور پر، براہ کرم آگاہ رہیں کہ ہماری آن لائن تجارت کی سہولت کے مندرجات نہ تو کوئی درخواست ہے، اور نہ ہی فنانشل مارکیٹ میں کوئی لین دین داخل کرنے کی پیش کش ہے۔ کسی بھی فنانشل مارکیٹ میں تجارت میں آپ کے سرمائے کے لئے ایک خاص سطح کا خطرہ ہوتا ہے۔
ہماری آن لائن تجارتی سہولت پر شائع ہونے والے تمام مٹیریل کا مقصد صرف تعلیمی/معلوماتی مقاصد کے لئے ہے، اور اس میں شامل نہیں ہے — اور نہ ہی اسے فنانشل، سرمایہ کاری ٹیکس یا تجارتی مشورے اور سفارشات؛ یا ہماری تجارتی قیمتوں کا ریکارڈ؛ یا کسی بھی فنانشل انسٹرومنٹ میں لین دین کی پیشکش؛ یا اسکے لئے مانگ؛ یا غیر متنازعہ مالی تشہیرات پر مشتمل سمجھا جانا چاہئے۔
کوئی تھرڈ پارٹی کانٹینٹ، نیز XM کے ذریعہ تیار کردہ کانٹینٹ، جیسے: راۓ، خبریں، تحقیق، تجزیہ، قیمتیں اور دیگر معلومات یا اس ویب سائٹ پر مشتمل تھرڈ پارٹی کے سائٹس کے لنکس کو "جیسے ہے" کی بنیاد پر فراہم کیا جاتا ہے، عام مارکیٹ کی تفسیر کے طور پر، اور سرمایہ کاری کے مشورے کو تشکیل نہ دیں۔ اس حد تک کہ کسی بھی کانٹینٹ کو سرمایہ کاری کی تحقیقات کے طور پر سمجھا جاتا ہے، آپ کو نوٹ کرنا اور قبول کرنا ہوگا کہ یہ کانٹینٹ سرمایہ کاری کی تحقیق کی آزادی کو فروغ دینے کے لئے ڈیزائن کردہ قانونی تقاضوں کے مطابق نہیں ہے اور تیار نہیں کیا گیا ہے، اسی طرح، اس پر غور کیا جائے گا بطور متعلقہ قوانین اور ضوابط کے تحت مارکیٹنگ مواصلات۔ براہ کرم یقینی بنائیں کہ آپ غیر آزاد سرمایہ کاری سے متعلق ہماری اطلاع کو پڑھ اور سمجھ چکے ہیں۔ مذکورہ بالا معلومات کے بارے میں تحقیق اور رسک وارننگ ، جس تک رسائی یہاں حاصل کی جا سکتی ہے۔
