May 30, 2023

The need-to-know this morning

A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug's chances of entering the European market. STAT's Andrew Joseph has more.
Akebia Therapeutics plans to re-apply for the U.S. approval of its drug to treat anemia in patients on dialysis due to chronic kidney disease, based on new feedback received from the Food and Drug Administration. The Akebia drug, called vadadustat, is approved in Europe and Japan, but was rejected by the FDA in 2022.

theranos

Holmes is set to report to prison today

Theranos founder Elizabeth Holmes is going to prison today. She's expected at an all-female, minimum-security prison camp in Bryan, Texas, the Wall Street Journal writes. In addition to being ordered to pay $452 million in restitution to the investors she was charged with defrauding, Holmes — a mother of two under 2 — has been sentenced to serve 135 months in prison.

The prison camp will be close to home. Holmes grew up in Houston, which is about 100 miles away. The prison is largely geared toward women who have committed white-collar crimes and other relatively low-level infractions. The prison camp has a children's play space, and she'll probably be able to see her family on weekends. The food hall will offer vegetarian options, which will suit Holmes' current diet. The facility also has a library that, according to inmates, included a copy of "Bad Blood" as of earlier this year.

cancer

ASCO is coming up this week

The American Society of Clinical Oncology's annual meeting kicks off on Friday, and as always, closely followed data presentations could change the way cancer patients are treated — and move the stocks of the drugmakers involved.

We'll be watching results from the NATALEE clinical trial of Novartis' drug Kisqali, which aims to reduce the risk of recurrence in women with the most common type of breast cancer. AstraZeneca's blockbuster drug Tagrisso is already a standard treatment for certain patients with lung cancer, but its position could further strengthened by the reveal of a survival analysis from the ADAURA study.

Roche will present results from a mid-stage study of its anti-TIGIT checkpoint inhibitor tiragolumab in kidney cancer, which suggest skepticism about its future may be premature. LAG-3 is another buzzy immunotherapy target, which will be the focus of a presentation from Regeneron, showing encouraging, albeit early results for its drug fianlimab in advanced melanoma.

To keep up with the latest, sign up for STAT's pop-up ASCO newsletter.

antitrust

Brussels unimpressed by Illumina's 'delay tactics'

The European Commission believes Illumina is deploying "delay tactics" to slow litigation that would force the sequencing giant to divest Grail, which it absorbed for $8 billion against the wish of regulators there and stateside. Although Illumina is claiming that it's moving "as expeditiously as possible," the sequencing giant has appealed an EU antitrust decision to block the deal. It's resisting attempts from Brussels to expedite the final ruling, the Financial Times reports.

"Illumina doesn't want a fast process in court, they are playing delay tactics," a person with knowledge of the matter told FT. "The way Illumina is behaving contradicts its claim that it wants to solve the issue fast."

This all happens in the midst of a contentious battle between Illumina and activist investor Carl Icahn. Just last week, shareholders ousted the company's chairman over the Grail acquisition — though CEO Francis deSouza held onto his board seat.

cell atlas

Profiling tumor-infiltrating cells, and how they impact immunotherapy

Tumor-infiltrating T cells are being studied as potential tools for treating cancer, but they're still somewhat mysterious. A new study in Nature Medicine lays out a single-cell atlas of these cells, studying 308,048 transcriptomes taken from 16 cancer types. The work could help unravel why immunotherapies are effective in treating some cancers but not others.

For example, the study describes the T cell stress response state — identifying these "T-STRs" as a new form of immune cell that's distinct from CD4+ and CD8+ cells. When in this stress state, the cell seem to be less effective in fighting cancer. They are seen at higher rates after being exposed to checkpoint inhibitor therapies, particularly in people who aren't responsive to these medicines.

"The fact that these T-STR cells are found in many different types of tumors opens up a whole new world of possibilities that could have high translational potential," researcher Linghua Wang of MD Anderson Cancer Center said in a statement.

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