Health

Reading newsletter: Element, Pfizer, Illumina

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4 days ago

July 12, 2024

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Hello! Today we talk about the latest cash flow from an Illumina competitor, Adam discusses Pfizer’s plan for a once-a-day GLP-1 pill, and more.

What analysts think of Pfizer’s new GLP-1 plans

From STAT’s Adam Feuerstein: Pfizer’s decision yesterday to press ahead with a once-daily GLP-1 anti-obesity pill was met with a mix of cautious praise and skepticism from Wall Street jokers.

The oral drug, called danugliprone, is in the same class of injectable anti-obesity drugs as Wegovy and Zepbound. Last December, Pfizer discontinued a twice-daily version of the drug because its weight loss and tolerability profile was uncompetitive. Now Pfizer says it has selected a “modified-release formulation” of danugliprone that allows for once-daily dosing, pending the outcome of a dose optimization study.

Umer Rafat of Evercore ISI called Pfizer’s decision to do more preliminary work on “danu” – without committing to larger Phase 3 studies – the “right move”. But he noted that Pfizer may also be buying time while it explores other backup oral GLP-1 drugs from its labs.

Leerink’s David Risinger pointed out that Pfizer’s dose exploration study for the new version of danu, even if positive in early 2025, will not provide data on weight loss or side effects in patients. “We believe the company will next need to initiate a Phase 1b to evaluate efficacy and tolerability,” he wrote, adding that these data may not be ready until 2026 at the earliest.

Raymond James analyst Steven Seedhouse has a strong buy rating on Viking Therapeutics, which is developing its own anti-obesity drug, and as such has become a hot-button takeover target for pharmaceutical giants like Pfizer, which are falling behind Lilly and Novo Nordisk.

Commenting on the Pfizer news, Seedhouse mentioned his research note: “Are bad BID drugs good QD drugs? Pfizer apparently thinks so, but we say unlikely.”

The complications and benefits of CAR-T are becoming clearer

Last year, the FDA began investigating whether new lymphomas were linked to CAR-T therapy — a surprise, considering the therapy is used as a powerful treatment for blood cancers. Despite several studies, scientists have not yet found solid evidence that CAR-T directly causes these new cancers.

It seems more likely that patients’ existing risk factors and previous treatments contribute to these cases. The risk of developing a new cancer after CAR-T remains low and the benefits of the therapy still far outweigh the risks, researchers say. And the biggest concern for CAR-T patients remains infections, not new cancers.

Layoffs in biotechnology and a major exit in pharmaceuticals

Why are pharmaceutical companies cutting more staff than cash-strapped biotech companies? And who will Pfizer scout as its next science chief? STAT’s West Coast biotech reporter Jonathan Wosen joins “The Readout LOUD” to discuss what’s driving workforce cuts.

We also discuss a major change in Pfizer’s leadership and the debate over a new side effect linked to the diabetes drug Ozempic. Plus, entrepreneurs Alexis Borisy and Zach Weinberg call in to discuss their biotech incubator Curie.Bio and how they hope to “liberate the founders.”

Listen.

Element Biosciences raises another huge round

Element Biosciences, a San Diego-based rival to Illumina, just raised $277 million in Series D venture financing. The funding will help Element commercialize its Ativi benchtop genomic analyzer and launch its next-generation Ativi24 system, which will include cell profiling and multi-omics.

In May, STAT’s Jonathan Wosen spoke with Element CEO Molly He, who said that even when the company raised its previous round in 2021, they weren’t ready to go public yet — and still aren’t.

“We wanted to be able to predict exactly what we’re going to do in terms of revenue… that takes work and understanding our customers, the market and how our technology is perceived by the market,” she said. . “We are getting better and better at our prediction capabilities. But we’re not quite there yet.”

The case for adaptive experimental design

Healthcare is moving toward personalized, patient-centered care, and clinical trials should follow suit with adaptive designs, two experts in the field say. These trials are tailored based on real-time data, accelerating access to new treatments, reducing exposure to ineffective therapies, increasing patient safety and improving understanding of drug effects.

Collaboration between technology and patient advocacy can further accelerate medical research and innovation, experts say. Despite their complexity, advances in machine learning are making adaptive trials more manageable. Regulatory agencies such as the FDA support these designs and recognize their potential to make drug development more efficient and patient-focused.