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The Readout Damian Garde & Meghana Keshavan

Will Covid-19 antibodies actually matter?

A handful of drug companies, led by Regeneron Pharmaceuticals and Eli Lilly, are pressing forward with manmade antibodies that could treat and even prevent Covid-19. But as the world pours resources into an unprecedentedly fast vaccine effort, it’s increasingly unclear how useful those antibodies might be.

As STAT’s Matthew Herper and Adam Feuerstein report, the most advanced antibody projects are expected to generate early efficacy data in the coming months. The first studies will determine how much those antibodies benefit patients hospitalized with Covid-19. Later trials will determine whether they can function like vaccines, given to healthy people to prevent against a future infection.

But time might not be on their side. As former Food and Drug Administration Commissioner Scott Gottlieb points out, the federal government has prioritized vaccines over treatments for Covid-19, and if the administration’s ambitious goals come through, there may not be much need for antibodies by the time they’re ready for widespread use.

Read more.

2020 is already the biggest year for biotech IPOs

As of this week, biotech IPOs have raised more money in 2020 than in all of 2019, beating the all-time record by a few billion with about four months to go in the year.

According to the Wall Street Journal, biotech IPOs have amassed about $9.4 billion in 2020. That’s more than double last year and tops the 2018 record of $6.5 billion. And despite all the market enthusiasm, bankers are still managing to leave money on the table: On average, 2020’s IPOs have traded up more than 30% after their debut.

The exuberance around biotech is due in part to the Covid-19 crisis, which has seen the drug industry soar while other sectors have faltered. And it comes just ahead of the first biotech IPO this year with an intrinsic connection to the novel coronavirus. CureVac, a German company at work on a Covid-19 vaccine, is expected to go public later this month. According to its latest regulatory filing, the company intends to raise about $250 million at $16 a share, but if this year's dominant trends hold up, CureVac will be considerably more valuable than that post-IPO.

Inovio’s Covid-19 vaccine data remain a mystery

The first generation of Covid-19 vaccine candidates has made the trip from first injection to detailed Phase 1 data, giving the world’s virologists and immunologists, whether real or armchair, plenty to discuss.

That is, with one exception: Inovio Pharmaceuticals, which completed enrollment in April and declared victory via press release in June, is yet to publish its Phase 1 results. Yesterday, in concurrence with its quarterly earnings report, Inovio said its data were “currently undergoing peer review for publication at a top medical journal” and didn’t explain further.

Inovio stands out among its peers for providing particularly scant information in its initial press release. In June, the company said its vaccine led to “immunological response rates” in 34 of 36 patients in the trial, but did not disclose how many patients produced antibodies that neutralize the coronavirus, which would be key to determining whether the vaccine might protect against infection.

The latest big bet in precision medicine is near

Drug companies have made fortunes in the field of targeted cancer therapies, designing molecules that home in on ever-rarer alphanumeric mutations and charging impressive amounts of money for drugs that help small numbers of patients. Turning Point Therapeutics, on the other hand, is pitching a drug it believes can beat out competitors by hitting a few of those mutations at the same time. And soon we’ll know if that’s true.

In the coming weeks, Turning Point expects to have data from a trial testing its drug, repotrectinib, in six patient cohorts, including those with the cancer-related mutations ROS1 and NTRK, plus patients whose tumors have endured despite prior therapy. 

If everything goes to plan, Turning Point will have essentially built a better mousetrap in oncology, creating a treatment that can compete with lucrative drugs from Pfizer, Roche, and Eli Lilly. If not, the company’s $2.5 billion market cap probably won’t survive. We should know either way before the end of September.

More reads

  • Stephen Hahn, FDA chief, is caught between scientists and the president. (New York Times)
  • With Covid-19 halting clinical trials, wearables could be key — but data ‘wild west’ gets in the way. (STAT)
  • Kodak stock dives 30% after $765 million loan is put on hold. (CNN)
  • With Livongo’s arsenal of health devices, Teladoc is poised to move into remote monitoring. (STAT Plus)

Thanks for reading! Until tomorrow,

Tuesday, August 11, 2020

STAT

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