The new Moderna data are good

Moderna has unveiled more strong efficacy results from the main analysis of its Covid-19 vaccine trial, and said it now plans to seek immediate regulatory clearance in the U.S. and Europe.

This suggests that there might be two SARS-CoV-2 vaccines by year's end, STAT's Matthew Herper and Damian Garde write. Pfizer and its partner BioNTech are also poised for a vaccine rollout in December. 

The vaccine had efficacy against Covid-19 was 94.1%, and it seems to protect against severe forms of the disease. The study followed 30,000 participants, who reported 196 cases of the novel coronavirus — of which only 11 were in the vaccine arm. The study reported 30 severe cases and one death, all of whom were in the placebo group.

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Biogen's $1.53 billion gamble on depression

Biogen is betting $1.53 billion on an oral depression drug from Sage Pharmaceuticals that performed poorly in a major clinical trial — but still may have blockbuster potential. The drug, zuronolone, failed to beat placebo in a large major depression study. But three more trials are underway, including one for postpartum depression, and if they’re all positive, analysts project the drug could bring in more than $2 billion in revenue. If one or more fails, the company may never recoup its investment, STAT’s Damian Garde and Adam Feuerstein write.

“Biogen did extensive due diligence on the zuranolone data,” Sage CEO Jeff Jonas told STAT. “We are excited and optimistic about the drug as well, and we view this alliance as potentially enhancing the value of zuranolone beyond what we might have done on our own.” 

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The challenges of getting CAR-T abroad

Shuttling bespoke cell therapies across the globe and back again requires a sophisticated supply chain arrangement — one that’s been disrupted by Covid-19, STAT’s Eric Boodman writes. Closed borders and canceled flights have made it remarkably difficult for cancer patients requiring CAR-T therapies to get their medicines. 

But CAR-T companies are working hard to keep up. Kite Pharma’s Pieter Van Hengel, a supply chain expert, likened the challenge to ferrying essential medicines to regions of conflict. No matter how bad the situation is, there are always supply corridors.

“Even in these war zones, they smoke and drink Coca-Cola,” he told STAT. “So we’re confident that there is going to be a plane going from the E.U. to the U.S. What we need to figure out together is: How are we going to get on that plane?”

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A JAK inhibitor for severe asthma

Startup Kinaset Therapeutics launched today with $40 million in a series A round — developing a JAK inhibitor drug aimed at severe asthma. It’s meant to work by blocking the JAK receptors in immune cells that can exacerbate inflammation. Clinical trials for the drug, dubbed KN-002, will kick off next year, STAT’s Kate Sheridan writes.

Kinaset isn’t the only company developing a JAK inhibitor drug for asthma: Pfizer and AstraZeneca also have done work in this space. But Kinaset argues that its drug is a “best-in-class molecule,” as it targets all JAK enzymes, as opposed to one or two, like most other drugs in this category do. 

The company’s challenge, now, is to recruit patients into a respiratory trial — during a pandemic where they may be especially susceptible. 

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More reads

• Covid-19 vaccine studies may suffer as volunteers consider dropping out. (Wall Street Journal)
• UK to pilot blood test that may detect 50 types of cancer. (CNN)