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Stem cell sentience, unpacking Humira’s biosimilar, & CAR-T cancer therapy

February 13, 2023
Biotech Correspondent
Hi, it's Meghana! This week, we probe into the ever-pressing bioethics of stem cell research. STAT's Ed Silverman also has a new video discussing Humira's biosimilar competition — and how patients will pay for it.

Biotech

Consciousness in a petri dish

New advancements in stem cell research are raising complex ethical questions.  Take the example of lab-grown brain organoids, which develop from stem cells. They produce the same sort of electrical activity as full-size brains, which brings up sticky questions of consciousness and sentience in these tiny structures. Researchers like Alysson Muotri at UCSD say it's probably just a matter of time before consciousness is engineered in a petri dish. 

"I personally think it's inevitable to get there. But some people think this might be too early to discuss and we shouldn't because the funding agencies might get scared, the public might get scared, and that might create an unnecessary roadblock for research" he said, speaking last week at the Sanford Consortium for Regenerative Medicine in San Diego. "It is a balance. And how to navigate that? I don't have the right answer." 

Read more.


video

A biosimilar for Humira — and why it matters

For more than two decades, AbbVie has owned the world's best-selling medicine. The main patent on its drug Humira expired in 2016, but AbbVie managed to stave off other drug makers from producing their own versions of the monoclonal antibody. Now Humira is finally facing competition from Amgen's biosimilar, Amjevita. 

In a video, STAT's Ed Silverman explains the intricacies of pharmacy benefit managers, formularies, and a legal tactic called "patent thicketing," and how all of that impacts what patients with diseases like Crohn's and rheumatoid arthritis will pay for this important treatment. 

Watch here.



Closer look

Impressive CAR-T results in multiple myeloma

Abecma, a CAR-T therapy made by Bristol Myers Squibb and 2Seventy Bio, halved the risk of multiple myeloma relapse compared to standard treatment, a 386-patient Phase 3 trial shows. Participants taking the BCMA-targeted cell therapy went a median 13.3 months before their myeloma worsened, compared to 4.4 months in patients taking standard treatments. Beyond that, 71% of the Abecma-treated patients saw meaningful reductions in cancer cells, with 39% achieving a complete response. In comparison, 41% of patients on standard therapy achieved a response, with only 5% seeing a complete response. 

The study could allow for Abecma, a BCMA-targeted cell therapy, to be used earlier in the course of treatment. That said, six people died from Abecma side effects, including two from cytokine release syndrome. Only one person died due to side effects from standard treatment. 

Read more.


biotech

Blueprint CDK2 inhibitor trial put on partial hold

The FDA is putting a partial clinical hold on a trial from Blueprint Medicines that was studying its experimental CDK2 inhibitor, BLU-222, in advanced solid tumors. A "limited number" of adverse effects were showing up in some patients participating in the Phase 1/2 study. Specifically, they were experiencing light sensitivity and blurred vision.

Blueprint said the patients who are already enrolled will continue with the study, but no more will be added until the hold is lifted. The drug is being studied in several cancers, including breast, ovarian, and gastric cancers. Endpoints noted that Blueprint said it's working with the FDA closely to investigate the events and amend trial protocol, and that the company doesn't "anticipate significant delays" to BLU-222's development timeline.


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More reads

  • Hugh Auchincloss was Anthony Fauci's longtime deputy. Now he's taking his job as House Republicans probe the pandemic, STAT

  • Baxter begins layoffs of 'less than 5%' of workforce after posting $2.4B net loss in 2022, FierceBiotech

  • U.S. FDA puts partial hold on Blueprint Medicines' cancer drug trial, Reuters

Thanks for reading! Until tomorrow,


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