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Thursday, June 30, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, a daily look at the latest news in biotech. Today, we look at the FDA's latest oncology move, a stem cell controversy, and the changing state of ovarian cancer therapy. Need more? Visit statnews.com and follow us on Twitter.

The shadow dimming good news on ovarian cancer

Ovarian cancer patients finally got some good news when Massachusetts-based Tesaro unveiled exciting clinical trial data for its PARP inhibitor drug, niraparib, saying it “significantly prolonged” the amount of time before tumors grew in patients with recurrent malignancies. The news has stock prices — and analyst bullishness —soaring.

But here’s the rub: Despite a new wave of promising experimental drugs, ovarian cancer mortality remains stubbornly high -— in large part because of geography.

Patients who aren’t treated at well-trafficked oncology centers tend to receive suboptimal treatment for this confounding cancer, researchers are showing. And as drug regimens for ovarian cancer become more nuanced and complicated, this treatment gap is at risk of growing.

“It’ll get worse,” Dr. Leslie Randall, an associate professor of gynecologic oncology at UC Irvine told STAT. “As we come out with more novel treatments that are more complex to deliver, that disparity will only get worse.”

Read more.

The FDA boldly unveils a new acronym

Dr. Richard Pazdur is head of the FDA's OHOP but will now become acting director of OCE, which coordinates with CDER, CDRH, and CBER. (FDA)

Answering the call of Vice President Joe Biden and his cancer moonshot, the FDA is promising to speed along new oncology treatments, and now it has created a nebulous organization to do so.

The Oncology Center of Excellence, or OCE, will be a sort of hub for cancer regulatory work, Commissioner Robert Califf said. What does that mean? Not clear. Asked whether the OCE will have final say over product approvals or authority to order around other arms of the agency, an FDA spokesperson said it’s too early to say.

What we do know: Dr. Richard Pazdur, long the head of the agency’s oncology division, will serve as acting director. And that's a useful tea leaf. Pazdur is known as a creative regulator who balances rigorous review with the need for new treatments. Under his watch, the agency has quickly approved new drugs on small amounts of data — but limited their use to only the most serious of cancers. To get approval for wider use, companies need to show more data. 

"I think if you talk to patients that are facing life-threatening diseases, yes, they want a drug that is safe — that’s clear — but they also want it in a timely fashion," Pazdur told STAT’s David Nather yesterday in D.C. (He did not repeat the rather unfortunate metaphor he used earlier this year, when he told the New York Times he was  on “a jihad to streamline the review process.")

Seeds of lucrative discontent in academia

Are big, bad universities denying hard-working student researchers their due? You may start to see a flood of lawsuits arguing just that: “I have met numerous students and post-docs that feel as though their universities and professors have shortchanged them with respect to their inventive contributions,” patent attorney Brian D. O’Reilly told STAT.

O’Reilly represented Mark Charest, a former Harvard University doctoral student who sued his alma mater a few years back for allegedly coercing him into accepting unfairly low royalty payments after a pharma company licensed his work on a new way to manufacture tetracycline antibiotics.

Charest recently settled on terms he said he was “pleased” to call “equitable” — and his lawyer suggested that could open the door for other student lawsuits.

“I believe [students’] willingness to challenge the status quo is going to fundamentally alter the way that universities operate,” O’Reilly said.

How soon is too soon with stem cells?

The FDA is facing familiar pressure to speed up its consideration of stem cell therapies, with advocates pressing to get more candidates into clinical development and shorten the time it takes to win approval. But hucksters abound, scientists warn, and ceding ground could embolden them.

“There’s a risk that the dominant narrative, not just amongst the clinics, but in the broader field, becomes, ‘Hey, the FDA system is the problem. We need to weaken [regulation] to move forward,’” said Paul Knoepfler, a stem cell researcher at the University of California at Davis.

Read more.

A unicorn's horn gets $200 million longer

You are invited to seek out your own biotech metaphors in this image.

Moderna Therapeutics, a comically well-funded biotech, extended its relationship with Merck and will pocket $200 million in the process.

Merck is betting Moderna can help it develop cancer therapies customized to individual patients, as The Boston Globe reports. Moderna’s bedrock technology is designed to hijack the messenger RNA that tells cells what to do and reprogram it to produce therapeutic proteins. Under the collaboration, Moderna will try to craft personalized tumor-busting treatments that can work alongside Merck’s blockbuster oncology treatment Keytruda.

For those keeping score, the deal puts Moderna’s disclosed four-year cash haul at more than $1 billion, split between equity and partnering payouts. It has a pipeline of more than 50 projects and a chart of subsidiaries and collaborations that has come to resemble a modest star system. Tasked with somehow keeping all that straight are the company's roughly 350 employees, a group expected to grow past 500 this year.

But it’s not all good news for Moderna. In 2015, it topped CNBC’s list of most disruptive companies. This year? All the way down at No. 41.

More reads

  • The FDA has proposed new rules about what constitutes conflict of interest for members of its independent advisory panels. (STAT)
  • New Enterprise Associates has been the most active VC so far this year. (Pitchbook)
  • Who will get final credit for the discovery of CRISPR gene editing? (Bloomberg Businessweek)
  • Sam Isaly of biotech investor OrbiMed believes the sector has hit bottom and that valuations will soon be on the rise. (Bloomberg)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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