Breaking News

Vaccines for babies, Vir and WuXi's breakup, & a win for alopecia?

 

The Readout

Meghana here. Lots of Covid news today, plus some new data showing that JAK inhibitors are roundly effective for alopecia areata. 

Pfizer and Moderna both have VRBPAC meetings in June

Pfizer and BioNTech will be seeking emergency use authorization for their Covid-19 vaccine in children under age 5 this week. And the FDA plans on convening its advisory committee, VRBPAC, on June 15 to review the submission.

This decision follows news from the companies that the vaccine was well-tolerated in young children, with a strong immune response. It was 80% effective at preventing Covid infection at a time when Omicron was rampant. The pediatric dose is just one-tenth of an adult dose, and requires three separate injections. The safety profile was similar to placebo, Pfizer said in a statement.

The FDA also said it would meet June 14 to review Moderna’s application to use its vaccine in children and teenagers aged 6 to 17 years old. The next day, VRBPAC will review the new under-5 Pfizer data, along with Moderna’s application for authorization to use its vaccine in children under age 6.

Read more.

Vir and WuXi end two-year antibody partnership

Vir Biotechnology announced via a late Friday SEC filing that it’s ending a Covid-19 antibody collaboration with China’s Wuxi Biologics. The study included sotrovimab, Biospace points out, which lost its emergency use authorization last month after data showed it had low efficacy against Omicron BA.2. The two companies began collaborating two years ago on Covid-focused monoclonal antibodies identified by Vir. WuXi was meant to conduct cell-line, process, and formulation developments, as well as begin manufacturing fo the antibodies. The U.S. government had purchased 600,000 doses of sotrovimab in January.

For what it’s worth, a new preprint was released on medRxiv showing that sotrovimab was actually more effective at preventing severe Covid-19 outcomes than molnupiravir. The study, which was conducted in England, hasn’t been peer-reviewed.

Paxlovid, meet VV116

An oral derivative of remdesivir, dubbed by maker Shanghai Junshi Bioscience as VV116, reached its primary endpoint in a Phase 3 study comparing the experimental drug to Paxlovid. The trial studied how the drugs could treat mild to moderate Covid-19. Junshi said in a statement that it would be submitting a new drug application to regulators (though it was unclear which ones in particular) “in the near future.” The company hasn’t yet released the data.

VV116 is also being considered as a potentially effective treatment for respiratory synctial virus, per a recent Nature letter. Apparently the drug has shown activity against RSV in mouse models, so there’s a ways to go yet for this indication.

Concert’s JAK inhibitor allays alopecia

Another trial is showing that JAK inhibitors, commonly used for cancer, could be a powerful tool in treating alopecia: Phase 3 data from Concert Pharmaceuticals showed that 41.5% of people with alopecia had at least 80% scalp hair coverage after taking high doses of CTP-543, FierceBiotech writes. In comparison, only 0.8% of people on placebo had similar levels of scalp coverage. Concert’s clinical trial studied 706 adults with moderate to severe alopecia, meaning they had to have at least 50% scalp hair loss to enroll.

This data catches Concert up with Pfizer and Eli Lilly, which already have teed up JAK inhibitors of their own that help with hair regrowth. Concert’s shares rose 7% on the news; Mizuho analysts called the data “highly positive.” Concert’s data seems to be the best of the three, but the larger companies are likely to make it to the market faster.

More reads

  • EU health agency warns monkeypox could become endemic in Europe if outbreak continues. (STAT)
  • Federal judge blocks controversial facility from breeding, selling dogs. (Science)
  • PhD students face cash crisis with wages that don’t cover living costs. (Nature)
  • Seagen’s potential breast cancer blockbuster Tukysa shows promise in colorectal cancer. (FiercePharma)

Thanks for reading! Until tomorrow,

@megkesh
Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play

Tuesday, May 24, 2022

STAT

Facebook   Twitter   YouTube   Instagram

1 Exchange Pl, Suite 201, Boston, MA 02109
©2022, All Rights Reserved.
I no longer wish to receive STAT emails
Update Email Preferences | Contact Us | View In Browser

No comments