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The Readout Damian Garde & Meghana Keshavan

For Moderna, speedy vaccine development means skipping a big step

Moderna Therapeutics got a potential coronavirus vaccine from inception to trial-readiness in 42 days, setting an industry record. But moving that fast meant skipping the part where you test whether a would-be vaccine works in an animal exposed to the virus, adding uncertainty to a fluid situation.

As STAT’s Eric Boodman reports, this isn’t how vaccine development usually happens. Demonstrating efficacy in lab animals is normally a key step that proceeds human trials. But the coronavirus outbreak, which has resulted in more than 125,000 cases around the world, is not a normal setting.

The rapid pace of Moderna’s vaccine, for which a clinical trial is already recruiting, compounds an already risky situation. Moderna’s technique of using messenger RNA to create medicines has never proved itself in a large trial, much less resulted in an approved product.

Read more.

Engage has promising data. Now it needs money

Engage Therapeutics, a scrappily funded startup focused on epilepsy, has demonstrated that a once-failed drug can treat seizures. Now it needs to replicate the results in larger studies, which will mean once more convincing investors to back a family affair.

As STAT’s Kate Sheridan reports, Engage’s drug, a rescue inhaler loaded with a modified form of Xanax, charted a promising response rate in a study enrolling 76 patients with epilepsy. But that study looked only at hospitalized patients, and convincing the FDA will likely require trials in other settings. Funding the first study was not exactly easy, but Greg Mayes, who founded Engage after his son was diagnosed with epilepsy in 2014, believes the data make his company’s case more compelling.

“I’m going to be able to circle back to people who passed on the Series A and say, ‘Hey, look, here’s the good news,’” Mayes said. “I’m so excited to be able to do that.”

Read more.

How coronavirus is disrupting the business of biotech

Clean labs, safe clinical trials, and the free flow of capital are all essential to get things done in biotech. And each is imperiled by the coronavirus outbreak, creating headaches for companies trying to keep their employees healthy and their science intact.

As STAT’s Adam Feuerstein reports, biotech executives are losing sleep over coronavirus, as a global pandemic has led to shutdowns, restrictions, and a stock market swoon. The top priority is minimizing the risk to workers, executives said, but then come concerns about delays to clinical trials that rely on overburdened health systems and worries that raising capital — essential for biotech companies with no revenue — could be constrained by global financial panic.

“I’ve been in a constant text stream with other biotech CEOs,” said Nick Leschly, head of Bluebird Bio. “We’re all sharing information about what’s best to do.”

Read more.

New research could wed liquid biopsy and the microbiome

The majority of liquid biopsy researched has focused on spotting telltale tumor DNA in the blood to diagnose cancer. But a new method promises to spotlight cancer-related bacteria and viruses floating around in the bloodstream, lighting the way to a new avenue of research.

As STAT’s Rebecca Robbins reports, researchers at the University of California, San Diego, said they have developed machine learning models that might distinguish between cancer types based on microbial DNA in the blood.

To test the idea, the researchers sequenced blood microbes from 59 patients with prostate cancer, 25 patients with lung cancer, 16 patients with melanoma, and 69 healthy volunteers, and then challenged the models to differentiate between them. Those models correctly identified 86% of the people who actually had lung cancer and 100% of the people who did not. They also correctly distinguished between cases of prostate cancer and lung cancer 81% of the time.

It’s early days for the approach, and the results come with the sizable caveat that more patient data is needed. But the results introduce “a completely new kind of information that you can get out of a liquid biopsy,” said Rob Knight, a UCSD researcher and senior author of the study.

Read more.

More reads

  • Danish regulator eyes sanctions — including prison time — against trial sponsors that fail to post results. (STAT Plus)
  • Coronavirus could force difficult choices on health systems. (Financial Times)
  • The spread of Covid-19 and the Boston Marathon: We can run another day. (STAT)

Thanks for reading! Until tomorrow,

Thursday, March 12, 2020

STAT

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