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Friday, July 15, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily look at what's new in biotech. Need more? Visit statnews.com and follow us on Twitter.

A reminder of the real patients behind the data

Stephen estrada, who is fighting advanced colon cancer, calls his immunotherapy trial "my hail mary." (courtesy stephen estrada) 

News this morning of another death in a clinical trial: A brain cancer patient being treated with an experimental gene therapy from Ziopharm Oncology died from an intracranial hemorrhage 15 days after the treatment was injected into his brain, Adam Feuerstein reports for TheStreet. The company doesn't believe the treatment caused the death and the trial is continuing.

Juno Therapeutics, meanwhile, disclosed that a total of four young patients, not three, had died of brain swelling after taking its CAR-T drugs in clinical trials. (The fourth patient was in a different, earlier, trial than the one that recently stopped and restarted.)

Juno’s shares fell 5 percent on the day, as investors reacted with some wariness. But how are actual patients responding?

To find out, STAT’s Rebecca Robbins talked to cancer patients taking other experimental immunotherapy drugs. They described feeling a kind of survivor’s guilt as they processed news of the patient deaths in the recent Juno trial. "It's scary," one said. But they also called the trials their best hope and said they had no plans to back out.

"I’m hoping that people will realize that just because people died doesn’t mean we should stop," one said.

More here.

Mike Pence, friend to biotech

Indiana Gov. Mike Penceis one of literally millions of people who could be the republican vice presidential nominee. (AARON P. BERNSTEIN/GETTY IMAGES)

Depending on whom you ask, Indiana Gov. Mike Pence is either definitely, probably, or arguably going to be Donald Trump’s running mate. And while Pence has not always been on the side of public health, free press, or access to care, he’s apparently in the good graces of the biotech industry.

In 2014, BIO named Pence its governor of the year for "enhancing Indiana’s growth as a biotech hub." (Kendall Square it's not, but Indiana is home to the twin giants of Eli Lilly and Roche Diagnostics, and its life sciences industry employs about 56,000.)

The same year he was honored, Pence signed a bill defining how and when biosimilars can be used in lieu of originals. The law dovetails with BIO’s policy guidance by leaving the decision up to doctors, not benefits managers (who presumably would be more eager to switch patients to cheap biosimilars). 

And if it's not Pence? Trump could still end up with a BIO-backed veep. New Jersey’s Chris Christie is also a former BIO governor of the year. And Newt Gingrich spoke at the trade group’s 2016 conference, where he memorably called both Trump and Hillary Clinton a "gamble." 

'A terrible beauty is born'

Cervical cancer cells stained to highlight certain proteins — and look like celestial bodies. (NATIONAL CANCER INSTITUTE/WINSHIP CANCER INSTITUTE AT EMORY UNIVERSITY)

There's that William Yeats line: "All changed, changed utterly: A terrible beauty is born." That might have been about the cancer cell, as we see in a new National Cancer Institute project called "Cancer Close Up" — a series of images that depict the genesis of cancer cells and their migration through the body.

Read  — and see — more.

The -vant engine refuels

As Elizabeth Holmes' popularity wanes, Vivek Ramaswamy stands alone as biotech's favorite millennial. (Roivant)

Vivek Ramaswamy, the 30-year-old biotech CEO out to build “the Berkshire Hathaway of drug development,” convinced someone in Warren Buffet’s income bracket to back his idea. Viking Global, run by billionaire Andreas Halvorsen, invested an undisclosed sum in Ramaswamy’s Roivant Sciences. 

Roivant’s core hypothesis is that there are loads of promising drugs gathering dust on the shelves of big pharma, waiting for the right biotech entrepreneur to pick them up on the cheap and spin them into winning therapies.

Ramaswamy rose to fame in 2015 when one of his companies, Axovant Sciences, bought a once-failed Alzheimer’s treatment from GlaxoSmithKline for just $5 million and used it to pull off an IPO that valued the biotech at $3 billion. Axovant now trades below its IPO price, but Ramswamy hasn’t slowed the pace of -vant creation.

There’s Orphavant, focused on rare diseases; Dermavant, looking at skin conditions; Myovant, investigating endocrine disorders; and, most recently, Enzyvant, at work on enzyme-replacement therapies.

Now, with cash from Viking, Ramaswamy has a longer runway to launch his next sub-brand, likely hoping it fares better than Halvorsen’s last big bet in biopharma.

More reads

  • A regulatory setback for a Duchenne muscular dystrophy biotech could have a read-through to Sarepta Therapeutics. (TheStreet)
  • Venture investing in biotech slowed a bit in the second quarter, but still hit $1.7 billion, with Craig Venter's Human Longevity doing especially well. (Endpoints)
  • Juno Therapeutics spent $10 million to acquire a small Boston company with a drug that might improve the performance of its CAR-T therapies. (Press release)
  • Two biologists are using safe viruses in an attempt to stop dangerous ones, and their work has attracted the attention of DARPA. (Bloomberg)

Correction: Wednesday's Readout incorrectly grouped Sage Therapeutics’ drug for postpartum depression with a class of therapies called GABA antagonists. The drug is a GABA modulator.

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Thanks for reading! Until Monday,

Damian & Meghana

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