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The Readout Damian Garde & Meghana Keshavan

Novavax is $1.6 billion richer

Novavax, which has burned through $1.5 billion in its 32 years of existence, is about to make all of that back from the U.S. government, in exchange for 100 million doses of a coronavirus vaccine that may or may not work.

As STAT’s Helen Branswell reports, Novavax is the latest inductee into Operation Warp Speed, the Trump administration’s program to speed up the development of vaccines to prevent Covid-19. The $1.6 billion, which Novavax expects to receive in February, comes on top of $388 million the company received from the Coalition for Epidemic Preparedness Innovations, or CEPI.

As to whether Novavax’s vaccine works, the company expects to have data from a Phase 1 trial later this month. If everything pans out, Novavax said it will start a 30,000-volunteer Phase 3 trial in the third quarter.

Read more.

Regeneron and Lilly are going to teach us a lot about Covid-19

It may be well into 2021 before we have definitive data on any coronavirus vaccines. But antibody treatments, meant to block the virus directly, are much quicker to develop. And the leaders in the field, Regeneron Pharmaceuticals and Eli Lilly, are taking divergent approaches that will illuminate how best to treat Covid-19.

Regeneron is pressing forward with a two-antibody cocktail, believing that’s the best way to block the coronavirus we know today and offer protection against any so-called escape mutations, by which the virus evolves to evade the attack. Lilly, on the other hand, is developing a single antibody, which top scientist Daniel Skovronsky described as a matter of practicality over theory.

“Reducing the theoretical risk of escape mutations has a real cost, and the real cost is manufacturing, meaning you will have less doses available, meaning fewer people will be treated in this critical time period,” Skovronsky said yesterday in the latest edition of STAT+ Conversations. “So my view is we go for a single antibody, which means that we can treat twice as many people if it works.”

We’ll find out which approach was wiser in a matter of months.

Watch the full conversation.

Biotech embraces the blank check

For investors looking to get in on the boom in biotech IPOs, picking a target company means poring over SEC filings, digging through scientific papers, and enduring paragraph after paragraph of risk statements. But an increasing number of biotech stock pickers are offering to take investors’ money and do the work for them, launching financial vehicles that exist only to take private companies public.

Called special purpose acquisition companies, or SPACs, these blank-check entities have existed for years on Wall Street but are fairly new to biotech. Essentially, a name-brand fund forms a SPAC, invites investors to buy into it through an IPO, and then later chooses a company with which to merge, creating a publicly traded firm by reverse-engineering.

Biotech’s first SPAC came last year, courtesy of the bank Chardan, followed by one from Perceptive Advisors. Last week, biotech investor EcoR1 Capital pulled off a $125 million IPO for a SPAC of its own, and this week RA Capital is expecting to raise at least $100 million for a similar effort. Whether the micro-trend continues will likely depend on just how well their SPAC targets perform in the long term.

What’s going on with Moderna’s coronavirus vaccine?

Last week, we found out that Moderna’s closely watched coronavirus vaccine was going to be briefly delayed. This week, we found out the problem is internecine squabbling.

According to Reuters, Moderna’s scientists and executives have been less than cooperative with their partners at the National Institutes of Health, which is paying for the company’s 30,000-volunteer Phase 3 trial. Citing three people familiar with the process, Reuters reports that Moderna would be right on schedule if it didn’t “try to test every boundary,” as one person put it.

Moderna CEO Stéphane Bancel, speaking at the Fortune Brainstorm Health event yesterday, reaffirmed that the study would start by the end of this month and pointed to the inherent complexity of running large trials, likening the process to “landing a very big plane.” 

This will all be a footnote in history if Moderna’s trial begins on time, and it may well be forgotten if the vaccine ends up working. But if the latest delay is the first in a series, it’ll be worth asking why similar problems didn’t plague the NIH’s other corporate collaborators.

More reads

  • Did a pharma trade group try to sabotage a Dutch government report on compulsory licensing? (STAT Plus)
  • Cambridge biotech raises $110 million to advance treatment for blood cancer. (Boston Globe)
  • Proving predictions wrong, health tech funding keeps climbing. (STAT Plus)
  • What pandemic? Biotech floats break records. (Evaluate Vantage)

Thanks for reading! Until tomorrow,

Wednesday, July 8, 2020

STAT

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