Big pharma using genetic modification for cancer treatment. Angmoh the best indeed

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https://www.yahoo.com/now/bristol-myers-bmy-announces-data-163804956.html

Bristol Myers (BMY) Announces Data on CAR T Cell Therapy Breyanzi​

Zacks Equity Research
Sat, June 12, 2021, 12:38 AM·3 min read

 

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Bristol Myers Squibb BMY announced positive top-line results from the TRANSFORM study on Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy.

Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy. It was approved in February 2021 for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

 

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The TRANSFORM study has been designed to evaluate Breyanzi’s potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard-of-care regimen of high-dose chemotherapy and autologous stem-cell transplant.

The results of a pre-specified interim analysis conducted by an independent review committee showed that the study met its primary endpoint. Data showed a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care. The safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting.

 

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Bristol Myers will complete an evaluation of the TRANSFORM data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities.

Bristol-Myers’ shares have gained 7.9% year to date against the industry's decline of 1.9%.

 

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They have been studying t-cells since the 1990's but probably witheld its benefit to maximise profits from existing patents.

 

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The company’s performance in the first quarter of 2021 was dismal as immuno-oncology drug Opdivo’s sales declined as competition is stiff from the likes of Merck’s MRK Keytruda. Moreover, Revlimid sales weren’t impressive either.

Nevertheless, the recent approval of new drugs adds a new stream of revenues, which should propel growth in the coming quarters.

In March, the company and partner bluebird bio, Inc. BLUE obtained the FDA approval for Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory MM.

Last month, the FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).

 

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https://www.sgh.com.sg/patient-care/conditions-treatments/car-t-cell-therapy/other-information

CAR T-cell Therapy​

CAR T-cell Therapy - Other Information​

How does it work?
The cancer patient first undergoes a series of tests and screening to determine if CAR T-cell therapy is an appropriate treatment option and to ensure that the patient is fit to have CAR T-cell therapy.
If CAR T-cell therapy is suitable, blood is collected from the patient through a process called apheresis. Apheresis is when blood is withdrawn from the body and passed through a machine that separates one or more blood components from the blood. In this case, T-cells are separated out and the remaining blood components are returned to the body.
The extracted T-cells are then sent to a laboratory. In the lab, extra genetic information is added to the T-cells to re-programme them to destroy cancer cells. Proteins known as chimeric antigen receptors (CARs) are added into the T-cells to make them into CAR T-cells, modifying the T-cells to recognise an antigen (protein that stimulates an immune response) on the patient’s targeted cancer cells.
The genetically modified CAR T-cells are grown and multiplied into the millions in the lab and then put back into the same patient by infusion. In the patient’s body, the CAR T-cells target the tumour and start killing cancer cells. They multiply until all cancer cells are gone. CAR T-cells remain in the body for long periods of time and will reactivate if cancer returns, even years later.

 

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What cancers can be treated with CAR T cell therapy?

The FDA has approved CAR T-cell therapy for adult patients with certain types of blood cancers, including: Aggressive, relapsed or refractory diffuse large B celllymphoma, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, transformed follicular lymphoma, and mantle cell lymphoma.

Frequently Asked Questions About CAR T-Cell Therapy ...​

 

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What is CAR T-cell therapy?​

CAR T-cell therapy is a form of immunotherapy that uses specially altered T cells — a part of the immune system — to fight cancer. A sample of a patient's T cells are collected from the blood, then modified to produce special structures called chimeric antigen receptors (CARs) on their surface. When these CAR T cells are reinfused into the patient, the new receptors enable them to latch onto a specific antigen on the patient's tumor cells and kill them.

 

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HOW MUCH DOES CAR T cells cost?

The current list price for the approved CAR T-celltherapies is $373,000. If the prices dropped to $250,000 or $275,000, they would be cost-effective even if there are fewer cures than we hope. As data mature, if outcomes are good, we can then increase the price accordingly.1 Feb 2020

Are CAR T-Cell Therapies Worth the Costs? - ASH Clinical News​

 

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https://www.channelnewsasia.com/new...-among-children-kymriah-blood-cancer-14619968

24 Apr 2021 06:01AM

'Breakthrough’ therapy for the most common type of leukaemia among children approved in Singapore​

SINGAPORE: A type of cell therapy for cancer has been approved for use in Singapore, providing another treatment option for patients with certain types of advanced blood cancers which are not in remission despite having gone through other forms of treatment.

Such patients include children with acute lymphoblastic leukaemia - the most common type of paediatric blood cancer in Singapore - if they fulfil certain criteria.

 

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The new treatment works by removing disease-fighting cells called T cells from patients, genetically engineering them to attack cancer and putting the cells back into them.

Developed by Swiss pharmaceutical firm Novartis, the therapy is called CAR-T, or chimeric antigen receptor T-cell. It is marketed commercially as Kymriah.

It was approved under Singapore's new cell, tissue and gene therapy products (CTGTP) regulatory framework which came into effect on Mar 1.

Singapore is the first country in Southeast Asia to offer the treatment.

 

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Singapore General Hospital (SGH) is the first Kymriah treatment centre to become operational in Southeast Asia, Novartis said. The National University Hospital (NUH) is making the necessary preparations to become a qualified Kymriah treatment centre.

At SingHealth, which includes SGH, there have been a “number of patients” who have received the therapy as part of clinical trials, said Dr Hwang, who is also head of the SingHealth Duke-NUS Cell Therapy Centre and senior consultant for haematology at SGH.

As the therapy has only been recently approved, fewer than 10 patients have undergone the therapy out of the trial, and they are being monitored, he added.

"All patients who received CAR T therapy for lymphoma at SGH have responded very well to the therapy and are being monitored," he said.

 

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POTENTIAL SIDE EFFECTS AND MANAGEMENT

While the therapy could be lifesaving, it comes with potentially serious side effects.

One common side effect is cytokine release syndrome, which also signals that cancerous cells are being eliminated, the doctors said. The syndrome also means that the CAR T-cells are at work, eliminating the cancerous cells.

Symptoms can include high fever and low blood pressure in the days after treatment is given.

Other side effects include changes in the brain that cause swelling, confusion, seizures or severe headaches.

However, doctors said the side effects can be effectively managed by a trained clinical care team.

Similar to chemotherapy, CAR T-cells can kill off some of the good B cells that help fight infection, so the patient undergoing treatment may be at higher risk for infection, said Dr Hwang, adding that this can be managed.

 

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While Novartis did not say how much the one-time treatment is in Singapore, it costs up to US$475,000 (S$635,170) in the United States.

Dr Hwang said that the cost would “depend on the overall treatment that the patient receives for their condition”.

 

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https://www.popsci.com/car-t-cell-immunotherapy-cancer-FDA/​

Why is it so different from other cancer treatments?​

Traditional therapies like chemotherapy and radiation only target the cancer cells and tumors themselves. You need different types of drugs depending on the type of cancer, and once you stop giving a person the treatment, it quickly leaves the body or stops working. This treatment, and all immunotherapies to a certain extent, target the person’s immune system and harness it to fight the cancer. In theory, it works just like a vaccine: once the immune system is coaxed into fighting the unhealthy cells, it should keep fighting them for a lifetime. That’s the idea, anyway—there’s still a lot of research to do.

 

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Can it help all cancer patients?​

Right now, the drug is approved only for ALL at a small number of cancer centers across the country, and under very specific conditions: For people aged three to 25 with relapsed ALL that has not responded to conventional therapy. Since leukemia is a cancer of the blood, it’s relatively easy for engineered T-cells delivered via blood infusion to find, invade, and kill the diseased cells. That’s why doctors have been focusing on that cancer, as well as other types of leukemias, before trying to push the treatment forward for cancers in other parts of the body.

 

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Figuring out how to use the treatment on other types of cancer, including ones outside the blood that create solid tumors, is the next big hurdle for scientists to clear. The problem, according to June, is that in cancers that create tumors, the bad cells are really good at keeping invaders out of the growing mass. In pancreatic cancer, for instance, the cancer cells basically build a wall around the tumor, which poses a problem for T-cells trying to get to it. That’s also true for brain cancers. To make CAR T-cell therapy a viable option for those patients, scientists will have to figure out how to safely break down those walls.

In principle, June said, all forms of cancer can be targeted by immunotherapies. We just need to figure out how to get the treatments where they need to go—and how to keep cancer patients safe from their own immune systems.

 

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They have been studying t-cells since the 1990's but probably witheld its benefit to maximise profits from existing patents.

https://www.popsci.com/car-t-cell-immunotherapy-cancer-FDA/

CAR T-cell therapy was invented by a group of scientists, including Carl June from the University of Pennsylvania, about a half decade ago. It hit the public eye when doctors used it on a young girl named Emily Whitehead, a then six-year-old with a relapsed and aggressive form of ALL. The experimental treatment worked—Emily is now 12 and cancer-free—and sparked a number of clinical trials and partnerships with drug companies, including Novartis.

 

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First-engineered T cells with chimeric molecule (CAR-T cells) were developed in 1989–1993 by Israeli immunologists Zelig Eshhar and Gideon Gross.12 Mar 2020

A brief history of CAR-T cells: from laboratory to the bedside​