| | | |   | Hello, everyone. Damian here with the latest twists for two hotly debated biotech acronyms and the proud annual tradition of naming the industry's worst CEOs. | | | There’s still hope for an oft-debated cancer target Partners Gilead Sciences and Arcus Biosciences said their in-development immunotherapy reduced the risk of tumor progression in a mid-stage study, lending weight to a seemingly promising scientific theory that has grown controversial in recent months.
The drug, domvanalimab, is an antibody directed at TIGIT, which acts as a brake on the body’s immune cells. In Gilead and Arcus’ trial, patients with lung cancer were randomized to receive either a checkpoint inhibitor called zimberelimab or a combination of that medicine and domvanalimab. The combination reduced the risk of tumor progression or death by 45% compared to the zimberelimab group, and 41% of patients on the combo regimen saw their tumors shrink compared to 27% for patients on the single drug.
The news comes a few months after a rival TIGIT treatment from Roche failed in a pair of pivotal clinical trials, results that cast doubt on the viability of the target and the potential of similar medicines from Merck, GlaxoSmithKline, and Bristol Myers Squibb.
Read more. | Someone finally succeeded in NASH After a decade of fruitless pharmaceutical efforts to find a treatment for the prevalent liver disease NASH, Madrigal Pharmaceuticals, a small biotech company, managed to succeed where so many failed.
Madrigal’s NASH drug, resmetirom, reduced the fat deposits and fibrotic scarring that are hallmarks of the disease in a Phase 3 study enrolling nearly 1,000 patients, the company said yesterday. Madrigal has not released detailed data, but the results, combined with an earlier Phase 3 trial, are expected to be enough to satisfy the FDA, which would make resmetirom the first approved treatment for NASH.
The news nearly tripled Madrigal’s stock price. NASH, a form of fatty liver disease, is estimated to affect up to 6% of the U.S. population. For resmetirom, that means that even a 5% share of the potential market, assuming a price of $15,000 a year, would represent $8.5 billion in annual sales, according to Liisa Bayko, an analyst at Evercore ISI.
Read more. | How physicians and biotech are partnering to expand biomarker testing Personalized cancer care hinges on testing for the unique drivers of each person’s cancer, but practical challenges keep many people from getting the tests they need. Learn how oncology care providers and biotech are working together to overcome biomarker testing barriers and expand access for patients everywhere. | Stubborn stocks  Going into the fourth quarter of this year, a best-case scenario for biotech would have included Eisai’s treatment for Alzheimer’s disease standing up to scrutiny, Madrigal Pharmaceuticals’ NASH treatment working, and Gilead Sciences’ TIGIT drug not failing. As of today, each of those things has come to pass, and biotech stocks are still down.
The closely watched XBI index has fallen more than 30% in 2022, and what looked like a recovery in August has since dissipated. That’s despite all of the above and a few billion-dollar deals. | Who’s the worst CEO in biotech? The holidays are a time for gathering with loved ones, reflecting on the year that was, and, for STAT’s Adam Feuerstein, making a list of the worst (and best) CEOs in biotech.
The class of 2022 includes a would-be iconoclast who bet wrong, the litigious leader of a foundering drug developer, and the CEOs who bought into a trendy new way to alienate their own shareholders.
Read more. | More reads - Inflation caused another big drop in net drug prices, analysis finds, STAT
- FDA lifts hold on Bluebird's sickle cell disease therapy, Reuters
- Congress reaches major health policy deal on Medicare, Medicaid, and pandemic preparedness, STAT
| Thanks for reading! Until tomorrow,  | | | |
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