March 3, 2025

The need-to-know this morning

Takeda and Protagonist Therapeutics said their experimental drug called rusfertide achieved the efficacy goals of a Phase 3 study in patients with polycythemia vera, a type of blood cancer that causes the overproduction of red blood cells.

vaccines

Trump administration move to reevaluate Moderna contract generates concern among experts

The Trump administration is reconsidering a $600 million BARDA contract with Moderna to develop an mRNA-based H5N1 bird flu vaccine, raising concerns that doing so could hinder pandemic preparedness.

Outbreaks of avian flu in U.S. cattle — and 70 human cases — over the last year have deepened worries about a potential H5N1 pandemic. Were that to occur, experts stress it will be hugely important for vaccine makers to have made progress with alternative technologies beyond traditional egg-based production, which is slow and vulnerable to supply chain disruptions.

As STAT's Helen Branswell writes, mRNA vaccines are the fastest to make and the easiest to mass produce.

"We don't want to be in a situation where we're in a data-free zone and having to make educated guesses when it involves the health of so many people," said Luciana Borio, former director for medical and biodefense preparedness policy at the National Security Council. "We don't want to be in a situation where people don't have confidence in a vaccine that is forced through because we haven't done the work ahead of time."

Obesity

AbbVie enters obesity field with drug licensing pact

From my colleague Andrew Joseph: AbbVie said this morning that it has struck a licensing deal with Gubra, a Danish company, for rights to an experimental weight loss drug that targets amylin.

AbbVie made a $350 million upfront payment to Gubra for rights to the drug, called GUB014295. Gubra is also eligible to receive another $1.9 billion if certain development and sales milestones are met.

The agreement comes less than a year since Robert Michael took over as CEO of AbbVie and as the company looks for its next top-selling drugs following the loss of patent protection for its mega-blockbuster autoimmune treatment Humira. In a statement, Michael said that the Gubra partnership offers "a compelling opportunity based on the potential to address patient needs while also fostering long-term growth for our company."

vaccines

An easier path for makers of seasonal flu vaccines

From STAT's Helen Branswell: There have been concerns that production and delivery of next winter's flu shots might be delayed, given the unexplained cancellation of a meeting of the FDA's vaccines advisory committee, which had initially been scheduled for mid-March. But the results of a WHO-led process to pick the strains that the vaccines should target, which took place last week, suggest the job ahead of manufacturers shouldn't be a tough one.

Little is changing in next winter's Northern Hemisphere vaccines, members of the international committee that picked the strains announced Friday. The influenza A virus H1N1 and the flu B Victoria viruses are identical to those in the 2024-2025 vaccines. While the group recommended a different H3N2 component, it's the one that manufacturers are currently using to make vaccines for the Southern Hemisphere 2025 winter. Having experience with all three strains should make their work easier.

The FDA and CDC took part in the WHO process. The FDA said Friday it will make its recommendations to manufacturers after consulting with federal partners, adding: "We do not anticipate any impact on vaccine supply or timing of availability."

synthetic biology

Ginkgo subleases space amid financial struggles

Erstwhile synthetic biology darling Ginkgo Bioworks is showing further signs of decline: It's subleasing large portions of its Seaport headquarters in Boston as part of a broader cost-cutting effort.

"Please don't hesitate to reach out if you are a growing biotech looking for space in Cambridge or Boston. I am the friendliest biotech landlord here," CEO Jason Kelly told analysts last week. "We've been making headway on subleases, but we still have a lot of lab space available that we'd love to get you into."

The company was highly valued once, but now it's seen its stock plummet and is facing $65 million in annual excess lease costs. This all transpires amid a broader deline in biotech funding, and high lab vacancy rates in Greater Boston.

RESEARCH

Francis Collins retires from the NIH

Former NIH director Francis Collins has officially retired, leaving behind an agency facing budget cuts and mass layoffs under the Trump administration. Collins, a renowned geneticist known for his leadership in the Human Genome Project and other groundbreaking work in diseases like cystic fibrosis, cancer, and sickle cell disease, stepped down from the helm of the agency in 2021 to return to his lab. There, he was overseeing scientists studying diabetes and progeria, a genetic aging disorder.

In a statement announcing his retirement, Collins said NIH employees "are individuals of extraordinary intellect and integrity, selfless and hard-working, generous and compassionate." He added: "They personify excellence in every way and they deserve the utmost respect and support of all Americans."

The subtext was impossible to overlook.

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