A PARP successor? Michigan academic team touts potential of an aging — but still experimental — AstraZeneca drug in DNA damage repair

August 15, 2019 09:36 AM EDTUpdated 11:12 AM

John Carroll

A PARP successor? Michigan academic team touts potential of an aging — but still experimental — AstraZeneca drug in DNA damage repair

AstraZeneca has already made billions on their PARP Lynparza, working alongside rivals like GSK, Pfizer and Clovis to demonstrate the widening potential of a drug that throws a monkey wrench in the DNA damage repair process — allowing drugs to kill off cancer cells. Now a group of investigators at the University of Michigan have published new research to show how a similar approach targeting Wee1 has the potential to do the same for tough-to-treat cases of advanced pancreatic cancer.

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Andre Kalil, AP Images

February 27, 2020 10:24 AM ESTUpdated 6 hours ago

Jason Mast

Coronavirus

R&D

A 9/11-era Omaha facility, an old Ebola drug, and the ubiquitous Dr. Fauci: Inside the first US novel coronavirus trial

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Growing acceptance of accelerated pathways for novel treatments: but does regulatory approval lead to commercial success?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Brian Stuglik (file photo)

February 28, 2020 09:59 AM EST

Amber Tong

People

R&D

Turning focus to clinical work, Verastem axes 31 jobs, scales back cancer drug promotion after disappointing sales

Months after taking the helm at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a “new strategic direction” — but not before some layoffs.

Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

ENDPOINTS CAREERS

Clinical Trial Manager

Cold Genesys, Inc.

Irvine, CA

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Olivier Brandicourt (AP Images)

February 28, 2020 08:05 AM ESTUpdated 08:15 AM

Natalie Grover

People

Ex-Sanofi chief Olivier Brandicourt, current Blackstone advisor, jumps on Alnylam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Dan O'Day (AP Images)

February 27, 2020 06:44 PM ESTUpdated 3 hours ago

Jason Mast

R&D

UPDATED: A name emerges out of the Gilead M&A rumor mill, and it’s a cancer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

February 27, 2020 06:18 PM ESTUpdated 39 minutes ago

Natalie Grover

Cell/Gene Tx

Deals

UPDATED: Biogen makes another bold Alzheimer’s bet, dropping $350M upfront to partner with genome-editing focused Sangamo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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February 26, 2020 05:50 AM ESTUpdated 08:23 AM

Amber Tong

Deals

Takeda swoops in to buy little biotech partner and its celiac drug poised to 'change standard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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ENDPOINTS CAREERS

Associate- Science & Technology

Alexandria Real Estate Equities

San Francisco, CA

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February 28, 2020 06:55 AM ESTUpdated 10:12 AM

Amber Tong

Cell/Gene Tx

IPOs

Startups

Jim Wilson's gene therapy startup Passage Bio bucks market sentiments, raising upsized $216M IPO

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.

February 27, 2020 09:24 AM EST

Amber Tong

Cell/Gene Tx

People

Spark loses another top exec in the wake of $4.3B takeover by Roche — report

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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