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Cutting-edge CAR-T cancer therapy is now made in India — at one-tenth the cost

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Coloured scanning electron micrograph (SEM) of T lymphocyte cells (pink) attached to a cancer cell.

T cells (pink) attack a cancer cell (yellow) in this scanning electron micrograph image.Credit: Steve Gschmeissner/SPL

A small Indian biotechnology company is producing a home-grown version of a cutting-edge cancer treatment known as chimeric antigen receptor (CAR) T-cell therapy that was pioneered in the United States. CAR-T therapies are used mainly to treat blood cancers and have burgeoned in the past few years. The Indian CAR-T therapy costs one-tenth that of comparable commercial products available globally.

A single treatment of NexCAR19, manufactured by Mumbai-based ImmunoACT, costs between US$30,000 and $40,000. The first CAR-T therapy was approved in the United States in 2017, and commercial CAR-T therapies currently cost between $370,000 and $530,000, not including hospital fees and drugs to treat side effects. These treatments have also shown promise in treating autoimmune diseases and brain cancer.

India’s drug regulator approved NexCAR19 for therapeutic use in India in October. By December, ImmunoACT was administering the therapy to paying patients, and it is now treating some two-dozen people a month in hospitals across the country.

“It’s a dream come true,” says Alka Dwivedi, an immunologist who helped to develop NexCAR19 and is now at the US National Cancer Institute (NCI) in Bethesda, Maryland. Her voice becomes tender as she describes seeing the first patient’s cancer go into remission. These are people for whom all other treatments have failed, says Dwivedi. “They are getting cured.”

“It’s very positive news,” says Renato Cunha, a haematologist at the Grupo Oncoclínicas in São Paulo, Brazil. He says the Indian product could pave the way for making advanced cellular therapies accessible to other low- and middle-income countries. “Hope is the word that comes to mind.”

The product is also a reality check for researchers in high-income countries, says Terry Fry, an immunologist and paediatric oncologist at the University of Colorado Anschutz Medical Campus in Denver, who has advised the researchers involved in setting up ImmunoACT. “It lights a little fire under all of us to look at the cost of making CAR-T cells, even in places like the United States.”

Tremendous need

CAR-T therapy involves taking someone’s blood and isolating immune components known as T cells. These are genetically modified in the laboratory to express a receptor, known as a CAR, on their surface. This helps the immune cells to find and kill cancer cells. The engineered cells are then mass-produced and infused back into the patient, in whom they proliferate and get to work.

Data on demand for these therapies in India are limited, but one study looking at a specific form of leukaemia found that up to 15 people in 100,000 are diagnosed with the disease, half of whom relapse within two years of receiving treatment, such as chemotherapy, and who subsequently choose palliative care1. There is a “tremendous patient need”, says Nirali Shah, a paediatric oncologist at the NCI, who is also an academic collaborator of the researchers at ImmunoACT.

NexCAR19 is similar to its US counterparts, yet distinct in key ways. Like four of the six CAR-T therapies approved by the US Food and Drug Administration (FDA), it is designed to target CD19, a marker found on B-cell cancers2. However, in existing commercial therapies, the antibody fragment at the end of a CAR is typically from mice, which limits its durability because the immune system recognizes it as foreign and eventually eliminates it. Therefore, in NexCAR19, Dwivedi and her colleagues added human proteins to the mouse antibody tips.

Lab studies showed that the ‘humanized’ CAR had comparable antitumour activity to a mouse-derived one and induced the production of lower levels of proteins called cytokines2. This is important, because some people with cancer who receive CAR-T therapy experience an extreme inflammatory reaction known as cytokine-release syndrome, which can be life-threatening.

Trial data

Early-stage clinical trials for NexCAR19 in adults with different forms of lymphoma and leukaemia, showed that in 19 of the 33 people who received the therapy, the tumours had completely disappeared at the one-month follow-up3. The tumours in another four people had shrunk by half — achieving an overall response rate of 70%. Trial participants will be followed for at least five years.

“Whether this will hold or not is something only time will tell,” says Hasmukh Jain, a medical oncologist at Tata Memorial Centre in Mumbai, who led the trials.

Natasha Kekre, a haematologist at the Ottawa Hospital, points out that the results are based on a small number of participants with a range of blood cancers, which makes it difficult to assess the treatment’s efficacy for specific cancers.

Only two of the participants experienced more severe forms of cytokine-release syndrome, and none had neurotoxicities, another common but temporary side effect of CAR-T therapy.

The safety profile is better than that of some of the FDA-approved CAR-T treatments, says Kekre. This could be related to the product, as well as to years of the scientific and medical community learning how to better care for patients, she says.

Humanizing the CAR probably contributed to the therapy’s positive safety profile, says Rahul Purwar, an immunologist at the Indian Institute of Technology Bombay, and founder of ImmunoACT. But others say that link has yet to be established.

Fry says the setting and type of patient treated in India could also affect the results. “The toxicity profile of CAR-T cells is driven by a lot of other patient factors.”

A technician at work in the ImmunoACT cGMP Facility for NexCAR19 Production.

A member of the ImmunoACT team preparing the NexCAR19 cancer treatment.Credit: ImmunoACT

Slashing costs

Although the treatment’s price tag is still high for many Indians, whose annual gross national income per capita is less than $2,500, NexCAR19’s cost offers hope that CAR-T therapy can be made more cheaply in other countries and contexts. To slash costs, the team developed, tested and manufactured the product entirely in India, where labour is cheaper than in high-income countries.

To introduce CARs to T cells, researchers typically use lentiviruses, which are expensive. Purchasing enough lentiviral vector for a trial of 50 people can cost up to US$800,000 in the United States, says Steven Highfill, an immunologist at the US National Institutes of Health Clinical Center in Bethesda, who has advised the Indian team. Scientists at ImmunoACT make this gene-delivery vehicle themselves.

The Indian team also found a cheaper way to mass-produce the engineered cells, avoiding the need for expensive automated machinery, says Highfill.

Patients’ costs are further reduced by the therapy’s improved safety profile compared with some of the other FDA-approved products, Purwar says. This meant that most patients did not need to spend time in intensive-care units.

Purwar hopes to further cut costs, including by scaling up production. ImmunoACT is planning to export the therapy to Mexico, and to develop new products, including a treatment for another form of blood cancer known as multiple myeloma.

But ImmunoACT faces competition. Several other Indian companies have launched local CAR-T trials, including Immuneel Therapeutics in Bengaluru, which has licensed technology developed by Spanish academics.

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Bisnis Industri

Art therapy app Groodles promotes mindfulness and creativity

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Use art therapy from Groodles to promote relaxation and emotional expression, now $39.99.
Add art therapy to your emotional health regimen with Groodles, on sale for less than $40 for life.
Photo: Cult of Mac Deals

Art therapy can be a powerful tool for your emotional well-being, yet it can be difficult to find accessible tools to use it to its maximum potential. Groodles changes that by putting an art therapy app on your iPhone or iPad.

Named one of AppAdvice’s top apps of January 2024, Groodles is designed for all ages and to be as accessible as possible. Children and adults alike can benefit from Groodles and its promotion of art therapy for self-expression and stress relief. Right now, lifetime access costs just $39.99 (regularly $149).

Groodles art therapy app stimulates creativity and healing

If you use the Apple Watch’s Breathe app, you know that taking a moment to center yourself can pay off in big ways. Designed to offer art therapy as a means of relaxation and healing, Groodles serves up thoughtful exercises for unwinding and alleviating stress. It provides a healthy and safe space for users old and young to express and process their emotions. It also well nurtures users’ creativity, stimulating the imaginative parts of their minds.

Groodles’ exercises fit into busy days, allowing you to unplug and take a moment for yourself through art. Use the art therapy app to unwind before bed, to start your day or as a midday break to reflect.

Gamefiy mindfulness with an app you can use anywhere

With regular use of Groodles’ art therapy, you might discover hidden parts of yourself and gain a greater understanding of your emotions. As you continue using the app, you’ll unlock beautifully illustrated badges to encourage you to keep going. It’s an easy way to build a personal art therapy practice.

With Groodles, you might find that you enjoy a greater sense of independence and self-control. You can even boost your self-esteem and practice daily gratitude by integrating art therapy into your everyday life.

Save on Groodles, an art therapy app that will help you unwind

Ready to unwind more mindfully and engage in meaningful self-expression? Grab lifetime access to the Groodles art therapy app for just $39.99 for a limited time.

Buy from: Cult of Mac Deals

StackSocial prices subject to change.



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News

Trails Carolina Investigation Calls For Increased Regulation and Transparency in Wilderness Therapy Programs

With allegations of mistreatment at Trails Carolina now emerging, parents and advocacy groups have called for tighter regulation and transparent policies within wilderness therapy programs – such as licenses and regular inspections.

Trails Carolina “Investigation” claims their staff receive extensive training in topics like first aid, nutrition, suicide prevention and crisis de-escalation; however, former employees have shared disturbing insights.

What is the investigation into Trails Carolina?

Recent months have witnessed numerous allegations of mistreatment against Trails Carolina, a wilderness therapy program offering help for adolescents facing emotional and behavioral challenges. These claims were met with great concern from regulatory bodies, families of former participants and independent investigators.

Allegations against Trails Carolina and other wilderness therapy programs range from emotional abuse, neglect, and physical maltreatment; these claims have sparked multiple investigations to ascertain their veracity while assuring all teens participating are safe from further mistreatment.

Although New Leaf claims their staff receive extensive training, former students and their families have shared accounts that dispute this claim. Their stories underscore the need for increased transparency, accountability, and licensing requirements in wilderness therapy programs – particularly important when families consider sending their adolescents into wilderness therapy programs; prioritizing research, consulting mental health experts for advice, and carefully considering any pros or cons when selecting programs is vital to ensure optimal results.

What are the allegations against Trails Carolina?

Trails Carolina, a wilderness therapy program renowned for helping troubled teens, has received praise from some families as an aid for troubled teenagers. Unfortunately, it has also faced allegations of mistreatment and abuse ranging from physical abuse to emotional manipulation and neglect by former participants and their families – these allegations highlight the need for greater oversight and transparent policies in wilderness therapy industry.

Trails Carolina stands accused of neglectful and negligent treatment in relation to the death of one of their teens who participated in its program, who at 14 at the time, ran away and attempted to scale a tree, only to fall and fracture his femur, leaving them to languish in the forest for up to 12 days before they were found and assisted. Trails Carolina failed to notify emergency authorities when this had happened.

Trails Carolina was also accused of sexually abusing a teenage girl. According to her father, Trails Carolina sexually abused his daughter; this claim has since been disproven by them.

What has Trails Carolina said about the allegations?

Trails Carolina has acknowledged allegations leveled against it, promising to cooperate with ongoing investigations and review their operations as they move forward with treatment methods that prioritize participant safety and emotional well-being.

Allegations of neglect and harm have come from interviews with former participants, medical records, lawsuits and media coverage. These allegations demonstrate the need for tighter oversight of wilderness therapy programs as well as increased transparency from those operating them.

Wilderness therapy offers adolescents struggling with emotional or behavioral challenges an invaluable opportunity for healing and personal growth, but it must adhere to rigorous protocols and be overseen by those possessing sufficient training and experience.

Trails Carolina claims that primary therapists are available two to three days each week to oversee individual student treatment plans and extensive staff training in first aid, wilderness survival and crisis de-escalation.

What does the investigation mean for families?

As these troubling allegations surface, a rigorous review must take place of Trails Carolina’s practices and the wider troubled teen industry. Transparency, independent oversight and commitment to participant safety must remain top priorities as we chart a path forward.

Trails Carolina emphasizes its staff are experienced therapists, wilderness survivalists and medical professionals who understand the complex world of adolescent development and the necessity of participant safety. An eight-year independent study also confirms this finding with positive results for its clinical outcomes compared with similar nature-based therapy research studies and families have reported positive changes in both teens’ behavior and family relationships as a result of using Trails Carolina therapy services.

Former participants and their families have filed complaints about mistreatment at this program, such as physical restraint, isolation and emotional manipulation used to discipline students. When one teen went missing, rescue crews have complained about not receiving details about his location which may hinder efforts to find him alive. Furthermore, inspection reports reveal the program frequently failed to report violations regarding health and safety violations such as improper medication handling or lack of sanitation.