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The Readout Damian Garde & Meghana Keshavan

Your guide to Biogen's big day

After years of scientific promise, clinical disappointment, and regulatory controversy, today we’ll finally learn whether aducanumab, Biogen’s treatment for Alzheimer’s disease, will become an FDA-approved medicine. Here’s a cheat sheet for what promises to be a watershed moment for the field.

What’s the controversy? Biogen ran two Phase 3 trials to prove aducanumab’s merits and then ended both of them early because the drug appeared to have failed. Months later, on re-examination, Biogen declared one study a success and claimed that patients who got the high dose for an extended period of time showed a benefit. To skeptics, that’s a muddled dataset that demands another trial. To supporters, it’s enough evidence to justify approval in a field with no disease-modifying therapies.

What’s at stake? There are nearly 6 million people with Alzheimer’s in the U.S., and it's been two decades since a treatment has been approved. Biogen’s drug, which is meant for patients with early-stage Alzheimer’s, offers hope for a better quality of life. The decision is also a massive referendum on treatments that target a toxic brain plaque called amyloid, whose role in Alzheimer’s disease has been fractiously debated for decades. And for Biogen itself, aducanumab’s approval would guarantee billions of dollars of revenue over the next decade, while its rejection would shine a light on the company’s struggles to grow its business and force management to make some tough decisions.

Who gets to decide? Billy Dunn, head of the FDA’s Office of Neuroscience, has presided over the aducanumab review alongside his deputy, Eric Bastings. Those two have signatory authority over the application, but given all the attention on aducanumab, it’s likely their boss, Patrizia Cavazzoni, will be involved.

Stay tuned to STAT for coverage of the FDA’s decision, whenever it arrives, plus stories on the many implications for science, medicine, and biotech.

A positive NK cell trial

An experimental natural killer cell-based immunotherapy from Fate Therapeutics has induced complete tumor responses in 56% of the patients with advanced lymphoma in an early-stage clinical trial. It’s positive news, no doubt, but the trial was small — just 11 patients — and the durability of these responses is still a big question mark. 

The therapy, called FT516, is a genetically enhanced NK cell that has a CD16 receptor on its surface. The receptor allows FT516 to link up with tumor-killing antibody drugs, which is meant to enhance their efficacy. The patients in the trial were given the off-the-shelf Fate therapy in conjunction with Rituxan, a commonly prescribed antibody drug.

Read more.

Biotech does reality TV

“Unicorn Hunters,” a new reality show, invites viewers to invest in the startups they see on TV. The judges include Apple cofounder Steve Wozniak, former U.S. Treasurer Rosie Rios, and, naturally, former NSYNC band member Lance Bass. They form what the show calls a “Circle of Money,” in a new genre they’ve coined “enrichtainment.” 

The goal, the show's producers say, is to help normal people access the high-risk, high-return world of the private markets, STAT’s Kate Sheridan writes. One of the companies featured, Starton Therapeutics, is working on patches that deliver cancer therapeutics and anti-nausea medication. 

“After this, we’re going to be well-known as a company,” CEO Pedro Lichtinger told STAT. 

Read more.

vaccine dissemination plan from the EU

Debate’s been swirling over how to provide equitable global access to Covid-19 vaccines. The World Trade Organization has already developed a plan to protect vaccine patent rights. And now, the European Union has its own competing plan that it describes as a “multilateral trade response.” It includes limiting export restrictions, tiered pricing, new investments in manufacturing plants in developing countries, and other such measures. 

But the EU plan is “meaningless,” said Northwestern intellectual property expert Brook Baker — and a “diversion tactic to try to stall progress.” The EU plan wouldn’t allay shortfalls in vaccine supply around the world, he said, and that it wouldn’t likely incentivize pharmaceutical companies to share their IP. 

Read more.

More reads

  • Helix doubles down on Covid-19 surveillance with $50 million Series C. (FierceBiotech)

Thanks for reading! Until tomorrow,

Monday, June 7, 2021


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