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Biotech bailouts, improving CAR-T, & Novavax's latest delay

 

The Readout

Hello, all. Damian here with news of a massive buyout premium, the latest in CAR-T research, and a neurologist's take on lecanemab.

Scientists dredge up clues on why CAR-T doesn’t always work

While CAR-T cancer therapy can produce dramatic benefits for some patients, a stubbornly high percentage see their tumors return over time. Two research teams mounted independent efforts to figure out why, and they hit on an identical explanation.

As STAT’s Angus Chen reports, it all comes down to which T cells get CAR’d. Studying patients whose cancer returned despite CAR-T therapy, scientists from Stanford University and Harvard University were surprised to find regulatory T cells, or Tregs, among the genetically modified cells. In healthy patients, Tregs operate like safety switches to the T cells that attack infections, preventing the body’s natural defenses from overreacting.

For patients undergoing CAR-T treatment, the presence of Tregs appears to blunt the cancer-killing effects of the therapy by curtailing the immune response. That suggests drug companies might be able to improve patient responses by sorting out Tregs in the manufacturing process.

Read more.

Deus ex pharmaceutica

For shareholders of the more than 100 biotech companies worth less than their cash reserves, there’s always hope that a given firm will get so cheap that a deep-pocketed pharma company will swoop in and buy it outright for cash. For shareholders of LogicBio Therapeutics, that hope was made real yesterday, when AstraZeneca acquired it at a roughly 660% premium.

The deal, which amounts to just $68 million in cash, values LogicBio and its drug-delivery technology at $2.07 a share. Before AstraZeneca disclosed its acquisition, the company traded for about 27 cents per share.

That creates a sizable windfall for any LogicBio shareholders who bought in as the company circled the drain, and it might help keep hope alive for the many biotech investors holding onto shares in similarly declining firms. But it’s also worth remembering that LogicBio went public at $10 a share back in 2018, and anyone who held on that whole time is looking at a roughly 80% loss.

Novavax’s timelines keep slipping

Novavax lost nearly 50% of its value in August after conceding that its long-delayed Covid-19 vaccine was not going to compete in the market for primary vaccinations. But a brighter day was ahead, according to the company, in which Novavax would launch an Omicron-specific booster that would be more desirable than the mRNA vaccines already on offer. It all depended on clinical data Novavax said would arrive “near the end of the third quarter of 2022.”

The quarter in question ended over the weekend, and no data have materialized. Depending on the length of the delay, Novavax might not be able to keep its promise of seeking FDA authorization for the Omicron booster before the end of the year, which means it might not be able to actually sell its updated vaccine until well into next year.

Meanwhile, the demand for strain-specific boosters appears to be meager. As of last week, only 7.6 million people in the U.S. have received one of the updated mRNA boosters authorized in early September, according to CDC data.

Which Alzheimer’s patients should get lecanemab?

To Jason Karlawish, a neurologist who leads the Penn Memory Center, the chasms and caveats in Aduhelm’s clinical data made the drug unprescribable to his patients with Alzheimer’s disease. Now, with Biogen and Eisai’s lecanemab poised to win an FDA approval of its own, the companies have a chance to learn from history.

To Karlawish, that means being transparent about the detailed data, quickly publishing a manuscript, and framing lecanemab’s risks and benefits in terms that clinicians actually use in their practices. The goal, Karlawish wrote in STAT, is basically to do the opposite of what happened with Aduhelm. 

“A trustworthy process is needed to review the lecanemab data and, if they hold up, I’ll have to decide whether to bring it into my clinical practice — or accept that it’s not ready for me to prescribe,” Karlawish wrote.

Read more.

More reads

  • At Verily, a growing line of business builds on a revolving door to the FDA, STAT
  • U.S. Supreme Court turns away Biogen bid to reinstate MS drug patent, Reuters
  • Nobel Prize in medicine awarded for research into the evolutionary history of humankind, STAT
  • Sumitomo offers to buy all of Myovant in deal worth $2.5 billion, Bloomberg

Thanks for reading! Until tomorrow,

@damiangarde
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Tuesday, October 4, 2022

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