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The Readout Damian Garde & Meghana Keshavan

What does $45 billion buy you these days?

Is clinical trial tourism a business? And will no one think of the patents?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, Moderna and Pfizer are poised to make billions of dollars from their Covid-19 vaccines this year, and we discuss what that massive infusion of cash portends for both companies. Next, Thomas Bollyky of the Council on Foreign Relations joins us to explain what the U.S.’s support for waiving Covid-19 vaccine patents means — and doesn’t mean — for the global vaccination effort. Finally, STAT’s Megan Molteni calls in to share the story of a little-known biotech company recruiting patients to Mexico with the promise of an anti-aging gene therapy in an unregulated clinical trial.

Listen here.

The U.S. broke the seal on waiving patents. Here’s what happens next

With all the teeth gnashed and garments rent over the U.S.’s endorsement of waiving Covid-19 vaccine patents, there’s a simple question on minds around the world: Now what?

As STAT’s Ed Silverman writes, the Biden administration opened up Pandora’s Box by backing the idea, but the proposal before the World Trade Organization has a long way to go before it could possibly take effect. The next negotiation is scheduled for next month, but actually passing a waiver would require winning over the likes of the U.K., Canada, Japan, and the European Union. German Chancellor Angela Merkel has already come out against the idea, which could be a bad sign for supporters of the proposal.

Domestically, the whole affair complicates the Biden administration’s inchoate relationship with the drug industry. Biden provided a pleasant surprise for industry when he decided to leave drug pricing reform out of his cornerstone economic legislation last month, but the White House’s embrace of patent waivers has roiled the pharmaceutical world and suggests the administration might have another lever to pull when it does take up the issue.

Read more.

What if you used two tumor-killing cell therapies at the same time?

That’s the idea behind a partnership between Nkarta Therapeutics and CRISPR Therapeutics, which plan to combine a pair of promising anti-cancer technologies that might prove complementary.

As STAT’s Adam Feuerstein reports, CRISPR Therapeutics has spent years using genome editing to create off-the-shelf CAR-T treatments for cancer, and Nkarta has been engineering natural killer cells for the same purpose. Yesterday, the companies united to work on what they’re calling “NK+T,” a combination therapy that could leverage the tumor-killing effects of each technology and create a more potent treatment.

Their work is in its early stages, but the two companies have initially set their sights on CD70, a protein found on some malignant blood cells and solid tumors. The plan is to engineer an NK cell directed at CD70 and then pair it with a modified T-cell either aimed at the same target or a complementary one.

Read more.

Launching drugs is hard

Biotech got a stark reminder this week that while being a small company doesn’t stop you from inventing new drugs, it can be a hindrance when it comes time to actually sell them.

A handful of closely watched drug launches fell well short of Wall Street expectations. Yesterday, Aurinia Pharmaceuticals reported that its recently approved treatment for lupus generated just $900,000 in the first quarter, below the $3 million consensus project. Days before, Deciphera Pharmaceuticals reported disappointing sales of its cancer treatment, and Esperion Pharmaceuticals posted revenue that came in nearly 50% below consensus estimates.

In each case, the fact that the world is going through a once-in-a-century pandemic did not help, as the marketing of many products relies on regular doctor-patient interactions, which are only gradually picking back up in the U.S. But this week’s cross-sector disappointment underlines an aged cliché in biotech investing: buy the data, short the launch.

More reads

  • New analysis finds global Covid death toll is double official estimates. (STAT)
  • Dyno raises $100 million to bring artificial intelligence to gene therapy. (Boston Globe)
  • U.S. SEC chair pledges trading rules review in first Congressional hearing. (Reuters)
  • Amazon Care signs first customer for burgeoning health business. (STAT+)

Thanks for reading! Until next week,

Friday, May 7, 2021

STAT

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