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STAT+: Cell therapy primed liver transplant patients to avoid organ rejection, small study shows

Immune tolerance has long been the holy grail in transplant medicine, a hoped-for end to the downsides of anti-rejection regimens for patients after they receive lifesaving organ transplants. A small, early-stage study now shows promise in taking cells from living donors — people giving a portion of their livers — to teach recipients’ immune systems to accept the foreign organs as their own and achieve the ultimate healthy outcome. 

Living donations take advantage of the liver’s ability to regenerate, meaning donors can part with a piece of their liver and later see it grow back. Recipients can regain enough liver function from the partial organs that also grow, replacing livers damaged by alcohol-associated liver disease, metabolic-associated liver disease, liver cancer, or other causes. Immunosuppression keeps their bodies from rejecting the new organs, but it also raises their vulnerability to infectious diseases and certain cancers. Serious side effects from the drugs include developing diabetes and kidney damage.

Cell therapy has been tried before to disarm the immune system’s attack by recruiting regulatory T immune cells taken from the donor. In the new study, whose results were published Friday in Nature Communications, different immune cells known as regulatory dendritic cells were obtained from donors’ white blood cells and generated in a lab. The idea behind both cell therapies is the same: to teach immune cells in the recipient’s body to treat the donated liver fragment as familiar tissue, not an invader be attacked.

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Immune tolerance has long been the holy grail in transplant medicine, a hoped-for end to the downsides of anti-rejection regimens for patients after they receive lifesaving organ transplants. A small, early-stage study now shows promise in taking cells from living donors — people giving a portion of their livers — to teach recipients’ immune systems to accept the foreign organs as their own and achieve the ultimate healthy outcome. 

Living donations take advantage of the liver’s ability to regenerate, meaning donors can part with a piece of their liver and later see it grow back. Recipients can regain enough liver function from the partial organs that also grow, replacing livers damaged by alcohol-associated liver disease, metabolic-associated liver disease, liver cancer, or other causes. Immunosuppression keeps their bodies from rejecting the new organs, but it also raises their vulnerability to infectious diseases and certain cancers. Serious side effects from the drugs include developing diabetes and kidney damage.

Cell therapy has been tried before to disarm the immune system’s attack by recruiting regulatory T immune cells taken from the donor. In the new study, whose results were published Friday in Nature Communications, different immune cells known as regulatory dendritic cells were obtained from donors’ white blood cells and generated in a lab. The idea behind both cell therapies is the same: to teach immune cells in the recipient’s body to treat the donated liver fragment as familiar tissue, not an invader be attacked.

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STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

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FDA imposes import alert on Indian plant after inspectors flag GMP failings

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Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.

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STAT+: Pharmalittle: We’re reading about a discontinued cancer drug, a Novo security breach, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

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