AstraZeneca wins priority review schedule for leukemia drug; Penn gene therapy upstart grabs $9.29M with Frazier’s help

April 3, 2018 10:08 AM EDT

Amber Tong

AstraZeneca wins priority review schedule for leukemia drug; Penn gene therapy upstart grabs $9.29M with Frazier's help

→ AstraZeneca has won a priority review for its anti-CD22 therapy moxetumomab for hairy cell leukemia. The pharma giant can now expect a decision on third-line use in the third quarter, marking another prospective advance for its critically important oncology pipeline.

→ With major help from Frazier Healthcare Partners, a stealthy gene therapy company from the University of Pennsylvania has secured $9.29 million in investment. Gene therapy pioneer James Wilson co-registered the company in 2016, the Philadelphia Inquirer notes, but has since been replaced on the board by Penn medical school vice dean Kevin Mahoney. Krishna Polu, a former CytomX chief medical officer who joined Frazier as an entrepreneur in residence, is the CEO. Several Frazier execs, including Patrick Heron and Tadataka Tamada, are also on the board.

→ Switzerland’s Glycemicon announced today that after a second closing, it has raised a total of $5.28 million (CHF 5.05 million) to advance cat and human studies of its neutraceuticals. The biotech is developing a pipeline of novel food products that manages prediabetes, the “gray area” between normal blood sugar levels and diabetes, as well as weight.

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Amber Tong

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April 3, 2020 09:33 AM EDTUpdated 11:46 AM

John Carroll

Bioregnum

IPOs

UPDATED: A small, obscure biotech just won big with their IPO. In this market. Are you kidding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

April 2, 2020 06:00 AM EDTUpdated 09:59 AM

John Carroll

Venture

ARCH chief Bob Nelsen has $1.5B to prove 2 simple points: ‘We’re in the most innovative time ever’ and investors are staying

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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April 1, 2020 07:26 AM EDTUpdated 09:47 AM

John Carroll

Coronavirus

Regulatory

Have a new drug that promises to fight Covid-19? The FDA promises fast action but some developers aren't happy

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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ENDPOINTS CAREERS

Principal - Alexandria LaunchLabs

Alexandria Real Estate Equities

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March 31, 2020 10:15 AM EDTUpdated 11:38 AM

John Carroll

Regulatory

Once furious over Novartis’ data manipulation scandal, the FDA now says it’s nothing they need to take action on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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March 31, 2020 07:21 AM EDTUpdated April 1, 04:19 AM

Endpoints Staff

Coronavirus

Covid-19 roundup: GSK, Amgen tailor R&D work to fit the coronavirus age; Doudna's genomics crew launches diagnostic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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March 30, 2020 05:42 PM EDTUpdated 05:53 PM

John Carroll

R&D

In a stunning setback, Amarin loses big patent fight over Vascepa IP. And its high-flying stock crashes to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Mene Pangalos via YouTube

March 30, 2020 07:10 AM EDTUpdated 10:35 AM

John Carroll

Pharma

R&D

AstraZeneca says its blockbuster Farxiga proved to be a game-changer in CKD — wrapping PhIII early

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Executive Director/Vice President of Business Development

Caribou Biosciences, Inc.

Berkeley, CA

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Aaron Royston, venBio

April 3, 2020 08:35 AM EDTUpdated 08:47 AM

Natalie Grover

In Focus

Venture

Investing in the time of coronavirus: the good, the bad and the hopeful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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April 2, 2020 06:23 PM EDTUpdated April 3, 02:27 PM

Endpoints Contributor

Biotech Voices

Coronavirus

Drug discovery in the age of coronavirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.