Breaking News

Moderna's RSV data, Sana's path to Phase 1, & exploring claudin-6

 

The Readout

Hey there, it's Meghana. Over the last decade, scientists have been designing novel technologies to give the immune system the upper hand. STAT’s latest report dives deep into the unique strategies being used in the world of targeted therapy. You can access it here.

Moderna’s RSV data is solid

Moderna is the latest company to unveil Phase 3 data for an RSV vaccine — and the results will likely add pressure on a soon-to-be crowded market. The vaccine lowered the rate of RSV-associated lower respiratory disease in a trial of 37,000 adults over the age of 60 in 22 different countries.

“It’s a fantastic result to have high-level efficacy against a disease that causes a lot of morbidity in the elderly, and it seems as though they’re finding consistently that they’re protecting relatively milder and more severe disease,” one former FDA official who now consults told STAT. “And this is a randomized and controlled trial so the quality of the data is likely to be very high.”

Pfizer and GlaxoSmithKline have already shown late-stage data that indicate they’ll be fierce competitors. They’re already primed for a marketing battle: Both have submitted their data to the FDA, with decisions expected this May. Analysts are projecting the RSV market in adults could be up to $7 billion, and that maternal market could be up to $3 billion.

Read more.

Sana’s preparing to finally provide some data

Cell therapy player Sana Biotechnology stayed stealth about its disease targets, while raising its eye-popping Series A of $700 million back in 2020. Its IPO was similarly grand, with $585 million raised in 2021. But today, the company’s stock is down 85% and it recently laid off 15% of its staff after shelving its ambitious attempt to regenerate heart cells.

Still, the company’s marching forward with promising animal data that its cell therapies might be effective in treating cancer, and also in replacing the pancreatic islet cells destroyed in type 1 diabetes. Both of these programs will enter phase 1 trials this year, with data expected soon after.

“I had this kind of naive view that if you start with the same cell every time, and you run the same process, every time, then you’re going to end up with the same product every time,” CEO Steve Harr told STAT. But creating consistent and stable cells “has been longer and more expensive and more challenging to do in every stem cell based program that we’ve done.”

Read more.

Claudin-6’s potential in solid tumor immunotherapy

Solid tumors remain a challenge for engineered cellular therapies like CAR-T. It’s hard to find molecular targets in these tissues that exist only in the solid tumor cancer cells, but not in healthy tissues — particularly those in the heart or brain. But scientists are zeroing on a protein called claudin-6, or CLDN6, that could hold potential as a target for cellular therapies. BioNTech, whose founders helped discover the protein as a possible cancer antigen, is one of several biopharma companies to work on a CAR-T therapy targeting CLDN6 that could be used for solid tumors. Other biopharma companies are working on bispecific antibodies targeting the protein.

“It’s really an ideal target in solid tumors,” BioNTech cofounder Özlem Türeci told STAT. “There are not many of them. In the late ‘90s, when we found CLDN6, we basically went through the entire genome, and there’s not much which compares to CLDN6 that you can find for solid tumors.”

Read more.

Pfizer to sell products to lower-income countries for cheap(er)

Pfizer will provide about 500 of its medicines and vaccines — most of which are off-patent — to 45 mostly low-income countries at not-for-profit prices. Last May, the company pledged to provide two dozen of its patent-protected products to 27 low-income countries and 18 lower-middle-income countries, most of which are in Africa. Pfizer is working with the countries to bolster their health care infrastructures, which include optimizing supply chains, improving medical education and training, and supporting diagnoses.

“We launched the [plan] to help reduce the glaring health equity gap that exists in our world,” CEO Albert Bourla said in a statement. “Our hope is to empower country governments and co-create solutions with them and other multi-sector partners to break down many of the system-level barriers to better health.”

However, it’s unclear how much of an impact this effort will have on health in these countries — since Pfizer’s non-profit prices still may be much higher than their generic equivalents. So even if they’re available for purchase, many of these low-income countries still may not be able to afford them.

Read more.

Roundabout way to acquire sought-after weight loss drugs

People are turning to online chemical suppliers to acquire a class of diabetes and obesity drugs that have become wildly popular for weight loss. At least a dozen websites offer drugs like semaglutide and tirzepatide. Although they include a disclaimer saying these substances should only be used for lab research, and not for human consumption, people have been ordering them and injecting them at home.

Semaglutide, sold by Novo Nordisk as Ozempic for diabetes or Wegovy for obesity, and tirzepatide, sold by Eli Lilly as Mounjaro, have been difficult to access. The drugs are costly, perpetually in short supply. So people are finding other ways to get the drugs — including procuring them through compound pharmacies.

“It just shows you the level of desperation that people have and the level of unmet need that we have when it comes to treating obesity effectively,” one weight management expert told STAT.

Read more.

More reads

  • EU plans changes to pharmaceuticals law to avoid medicine shortages, Reuters
  • Leap jumps ahead in cancer game with Flame merger, BioSpace
  • Large health insurers lowered barriers to fair access to some drugs, analysis finds, STAT
  • PwC predicts ‘flurry’ of $5 billion to $15 billion biotech deals in 2023, Endpoints

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

Wednesday, January 18, 2023

STAT

Facebook   Twitter   YouTube   Instagram

1 Exchange Pl, Suite 201, Boston, MA 02109
©2023, All Rights Reserved.
I no longer wish to receive STAT emails
Update Email Preferences | Contact Us | View In Browser

No comments