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The Readout Damian Garde & Meghana Keshavan

Novavax’s timeline keeps slipping

Novavax, poised to be the fifth company to market a Covid-19 vaccine in the U.S., has delayed reporting key Phase 3 data and now expects to disclose results by the end of June.

On a conference call yesterday, Novavax said it decided not to report interim results from its 30,000-volunteer North American trial and will instead wait for final data, which means the company won’t be able to file for U.S. and European authorization until the third quarter. Novavax has also run into manufacturing delays, and it doesn’t expect to reach full capacity until the fourth quarter.

Each delay complicates the role Novavax might come to play in the global pandemic response. By the time its vaccine would be ready for distribution in the U.S., the country might have little use for the 110 million doses it has reserved. Novavax’s vaccine could come in handy as a booster shot, but the company won’t have data to support that until the third quarter. 

The key to treating diseases of aging could be immunotherapy

A promising idea to treat disease of aging is simply blasting away the cellular detritus that gets in the way of healthy function, but drugs meant to do just that have thus far been disappointing. A novel method, tested in mice, suggests it might be possible to compel the immune system to turn its attention to those senescent cells, clearing them out without the need for potentially toxic drugs.

As STAT’s Megan Molteni reports, the key is natural killer cells, or NK cells, which are foot soldiers of the immune system that have proved increasingly valuable in treating cancer. Researchers at the University of California, San Francisco, found a way to activate NK cells in mice with high levels of senescent cells, finding that the immune system was adept at attacking the dead material while leaving healthy tissue largely unscathed.

This is early-stage research in a still-emerging field of study, but outside researchers said the method holds promise. Earlier approaches to attacking senescent cells brought off-target risks that might be avoided by using NK cells as an intermediary. And now there’s a biotech company, called Deciduous Therapeutics, pressing the idea toward a first clinical trial.

Read more.

Does AstraZeneca’s CEO deserve a raise?

AstraZeneca CEO Pascal Soriot, who once complained of being “the lowest-paid CEO in the whole industry,” is in line for a raise in the coming year, but the world’s most influential shareholder advisers are campaigning against it.

Soriot, whose pay package totaled more than $21 million last year, would be eligible for a larger cash bonus and more generous equity award in 2021, under a proposal up for approval at AstraZeneca’s annual shareholder meeting today. But as Reuters reports, ISS, Glass Lewis, and PIRC — three oft-obeyed corporate governance advisers — are recommending shareholders vote against the proposal, arguing that it’s too generous.

The issue highlights a long-running divide between AstraZeneca’s financial health and public standing: The company has had enviable success under Soriot, but you wouldn’t guess that from recent news coverage. In Soriot’s eight years in charge, AstraZeneca has outperformed its peers in major pharma and the top 100 stocks listed in London, the company pointed out. And yet in the past 12 months, AstraZeneca has failed to meet supply agreements for its Covid-19 vaccine and struggled to clearly communicate just how well the vaccine works.

2021’s other big Alzheimer’s news

Beyond the FDA-related angst surrounding Biogen and scientific discourse over Eli Lilly, there’s another late-stage treatment for Alzheimer’s disease with near-term news and plenty to debate.

Cortexyme, a billion-dollar San Francisco biotech, said yesterday that it expects to have Phase 3 data on its Alzheimer’s drug before the end of the year. The treatment, atuzaginstat, targets the bacteria P. gingivalis, which has been strongly linked to the advance of Alzheimer’s. Cortexyme’s trial has enrolled nearly 650 patients with mild to moderate Alzheimer’s, comparing atuzaginstat against placebo over 48 weeks. 

As tends to be the case in Alzheimer’s drug development, Cortexyme has had ups and downs with atuzaginstat. Back in December, the company’s stock price fell by nearly 50% after the trial cleared a planned interim analysis, which meant that independent monitors concluded the study wasn’t futile, but also that atuzaginstat wasn’t working so well that the trial could conclude early. Then, in February, Cortexyme fell another 35% when the FDA placed a clinical hold on an open-label extension study of atuzaginstat over concerns about liver toxicity. That didn’t impact the ongoing Phase 3 trial, but the two events in tandem have dimmed expectations for the final data.

More reads

  • FDA authorizes Pfizer’s Covid-19 vaccine for use in adolescents (STAT)
  • CDC’s slow, cautious messaging on Covid-19 seems out of step with the moment, public health experts say. (STAT)
  • BioNTech’s Covid-19 vaccine success sparks investments in German biotech. (Wall Street Journal)
  • Inside Pear’s ambitious plan to become the most prominent player in digital therapeutics. (STAT+)

Thanks for reading! Until tomorrow,

Tuesday, May 11, 2021

STAT

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