Roche pulls another major piece out of the wobbly Alzheimer’s jenga, shuttering crenezumab PhIIIs

January 30, 2019 05:55 AM EST

Roche pulls another major piece out of the wobbly Alzheimer's jenga, shuttering crenezumab PhIIIs

Amber Tong

Senior Editor

When AC Immune announced two years ago that its partners at Genentech is launching a second Phase III for its Alzheimer’s drug, CEO Andrew Pfeifer touted crenezumab as a “distinct” hope amid disappointing results of other anti-amyloid beta therapies, given at higher doses and targeting earlier stages of the disease.

Today crenezumab has become a big disappointment itself — marking another prominent failure in a frustration-prone field.

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Targeting a Potential Vulnerability of Certain Cancers with DNA Damage Response

Andree Blaukat

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

February 26, 2021 07:00 AM ESTUpdated 09:51 AM

Deals

Roivant parlays a $450M chunk of equity in biotech buyout, grabbing a computational group to drive discovery work

John Carroll

Editor & Founder

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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February 27, 2021 06:24 AM ESTUpdated 07:05 AM

Weekly

The future of mRNA, J&J's vaccine adcomm, Merck's $1.85B autoimmune bet and more

Amber Tong

Senior Editor

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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February 26, 2021 10:03 AM ESTUpdated 05:29 PM

Deals

R&D

Roche and Genentech researchers plot $53M discovery quest aimed at sparking a 'Holy moly' pivot in neuro R&D

John Carroll

Editor & Founder

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

February 25, 2021 08:31 AM ESTUpdated 09:46 AM

Editor's note

Follow biotechs going public with the Endpoints News IPO Tracker

Max Gelman

Associate Editor

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

February 24, 2021 10:50 AM ESTUpdated 11:53 AM

Deals

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sciences to focus on decentralized clinical work

Max Gelman

Associate Editor

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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February 26, 2021 09:00 AM EST

R&D

Amgen, AstraZeneca speed toward filing next-gen antibody for asthma after uncorking full late-stage data

Kyle Blankenship

Managing Editor

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

February 26, 2021 06:27 AM ESTUpdated 09:50 AM

People

With dust settled on activist attack, Laurence Cooper leaves Ziopharm to a new board

Amber Tong

Senior Editor

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

February 26, 2021 04:48 AM EST

Pharma

Regulatory

Why not? Sarepta’s third Duchenne MD drug sails to accelerated approval

Amber Tong

Senior Editor

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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