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Boosters approved, pandemic drug discovery, & a new enzyme replacement therapy

   

 

The Readout

Hiya, it's Meghana. Today, we cogitate on Merck's will-they-won't-they Seagen deal, discuss the new Covid boosters, and more. 

The FDA authorizes a new wave of Covid boosters

The FDA has sanctioned Pfizer's and Moderna's newest Covid booster shots, which more closely match the strains that are currently being transmitted in the U.S. Pfizer’s is authorized for people aged 12 and up, while Moderna’s is allowed in people older than 18. The shots still need a CDC signoff — but the agency’s vaccine advisory committee will be meeting today and could quickly recommend them.

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” FDA Commissioner Robert Califf said in a statement.

Read more.

A new Australian pandemic discovery center

Canadian oil and gas tycoon Geoffrey Cumming has donated 250 million Australian dollars to launch a new center for pandemic drug discovery. The initiative, which is called the Cumming Global Centre for Pandemic Therapeutics, will also receive 75 million Australian dollars from the Australian government over 10 years.

A number of similar efforts are popping up around the globe, backed by the NIH, the Gates Foundation, and pharmaceutical companies, to develop antivirals that might help prepare for and abate future pandemics. Three technologies are particularly promising for pandemic preparedness, the center’s leader told Reuters: nucleic acid therapeutics, treatments that modulate the innate immune response, and cheaper and simpler to use antibody therapies.

FDA approves a Sanofi enzyme replacement therapy

The FDA just approved Sanofi’s Xenpozyme, an intravenous enzyme replacement therapy for acid sphingomyelinase, in both children and adults. The rare genetic disease prevents the body from metabolizing certain fats and causes premature death. The drug reduces the buildup of sphingomyelin, and was demonstrably effective in a 31-patient trial, improving lung function while decreasing the size of the spleen and liver. Xenpozyme was approved in Japan this past month, and then in Europe in May, FiercePharma writes.

The progressive disease is extremely rare: Fewer than 120 people have been diagnosed with ASMD in the U.S., and about two-thirds are children. Though many people affected by the disease die in infancy, some can survive into adulthood — but ultimately die from respiratory failure. Xenpozyme does not cross the blood-brain barrier, so it doesn’t help with buildup of sphingomyelin in the central nervous system. Xenpozyme is meant to be administered every two weeks, and will be listed at $7,142.

Will the Merck/Seagen deal actually go through?

Merck’s struggles to close its Seagen deal illustrate how difficult it is to put a price tag on a promising cancer technology, Bloomberg writes. The acquisition has been stalled over a disagreement over the company’s final purchase price: Seagen, which lassos tumor-targeting antibodies to chemotherapy, has an estimated worth of $37 million. Seagen’s antibody drug conjugates have already been approved for four types of cancer, and it has the potential for many more.

But it’s still hard to know how impactful this technology will be in the long run — and analysts wouldn’t be surprised if the Merck deal falls through. These delays could create an opportunity for another company to take Merck’s place. But although Seagen’s technology is wildly lucrative, AbbVie learned a hard lesson with a similar deal with Stemcentrx — whose ADC failed in multiple trials.

“Just because you buy one of these, doesn’t mean it’s going to be a slam dunk,” one researcher told Bloomberg.

More reads

  • Guardant, Merck expand precision therapeutics collab, focusing on hard-to-treat cancer, FierceBiotech
  • Saudi anti-aging group links up with AFAR to dole out research grants, Endpoints

Thanks for reading! Until tomorrow,

@megkesh
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Thursday, September 1, 2022

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