Thursday, April 5, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews

CAR-T's getting mighty crowded


It’s just like the time Jon Snow and his men found themselves surrounded by an army of White Walkers.

That’s the thought flashing in our head after seeing this Adaptimmune CAR-T competitive landscape slide drop into our Twitter feed Wednesday. (Thanks, Brad Loncar.) And yes, perhaps we miss Game of Thrones a bit too much.

Gilead Sciences and Novartis control the only marketed CAR-T therapies today. (That’s them, all alone in the chart’s bullseye.) But they better have their heads on a swivel because a cellular therapy mob is bearing down from all directions. Let’s hope someone remembered to bring the dragonglass.

The Adaptimmune slide, which itself was adapted from research by Wells Fargo and presented Wednesday at a William Blair conference, underscores the huge R&D investment being made to invent new cancer therapies based on the genetic re-engineering of human T cells. The entire field is moving fast. This same slide presented one year from now will probably look very different. And like any GoT fan knows, some familiar and beloved characters will almost certainly meet an untimely end.

But finding patients for all those trials could be tough …

… without changes to patient enrollment criteria, according to an oncologist at UT Southwestern Medical Center in Dallas. Writing in STAT, Dr. David Gerber recounts times when he’s had a cancer patient who looked like an ideal candidate for a clinical trial on a newfangled treatment — only to find that some irrelevant blip on a health record rendered that patient ineligible.

The problem, Gerber writes, is that clinical trials on new technologies like immunotherapy are preserving the exclusion provisions from yesteryear’s studies on chemotherapies. That means the patient populations get ever narrower, making enrollment more time-consuming and leaving people who might benefit from experimental treatments on the outside looking in.

Read more.

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No boom/bust dichotomy, no worries in Washington

Three top hedge-fund investors really don’t buy the theory that biotech will soon trade its frothy euphoria for a descent into the valley of death. That’s what they told three STAT reporters at "Biotech Unfiltered," a STAT Plus subscriber event in New York last night.

The reason why? Biology. The drugs being designed and developed now are based on an almost infinitely better understanding than 20 years ago of the biology underlying the diseases they are supposed to treat, said Nathan Sadeghi-Nejad, a partner at Palkon Capital Management, as his fellow panelists agreed.

“I think biotech is in a position where tech used to be a while ago,” said Adam Stone, chief investment officer at Perceptive Advisors.  “So the cost of doing business is coming down, the cost of genomic screening is coming down, so you see a lot more targeted drugs.”

They also said they really, really like Scott Gottlieb and the way he’s running the FDA.  “I think he’s fantastic,” said Mark McInerney, a private Investor previously at Visium Asset Management.  “Trump’s best appointment, hands-down,” said Stone. And “the FDA is showing a fair amount of creativity” said Sadeghi-Nejad.

But they aren’t losing sleep worrying about what else happens in Washington. “I spent a lot of time in Washington in the lead-up to the ACA. And I decided that was huge amount of wasted time on my part,” said  Sadeghi-Nejad. “I didn’t like looking behind the curtain.”


Pharma's still unpopular with patient groups — but it used to be worse

A research firm called PatientView surveyed more than 1,300 patient groups from 95 countries about pharma's reputation. The result: Only 45 said the industry had an “excellent” or “good” rep last year.

That sounds bad, but it's actually an improvement. Last year, the same survey charted a 38 percent approval rating. So there's progress being made.

The sticking point, which may come as no surprise, is drug pricing. Just 13 percent believe pharmaceutical companies do an excellent or good job of disclosing or explaining their pricing policies, according to the survey.

Read more.

More reads

  • Gottlieb says Facebook, other tech companies must do more to stop illicit opioid sales. (STAT Plus)
  • Takeda's interest in Shire breaks mold of tame M&A by Japanese drugmakers. (S&P Global)
  • Will the Trump tariffs on China raise drug prices for Americans? (STAT Plus)

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