Covid-19 roundup: EU and AstraZeneca trade blows over slowdowns; Unusual unions pop up to test antibodies, vaccines

January 27, 2021 07:02 AM ESTUpdated 11:05 AM

Coronavirus

Covid-19 roundup: EU and AstraZeneca trade blows over slowdowns; Unusual unions pop up to test antibodies, vaccines

Amber Tong

Senior Editor

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

March 4, 2021 08:51 AM ESTUpdated 10:33 AM

Deals

UPDATED: Amgen snaps up cancer drug player Five Prime, adding PhIII-ready FGFR2b drug in $2B M&A play

John Carroll

Editor & Founder

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

March 4, 2021 06:57 AM ESTUpdated 4 hours ago

Discovery

In Focus

David Liu has a new big idea: proteome editing. It could one day shred tau, RAS and some of the worst disease-causing proteins

Jason Mast

Editor

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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March 3, 2021 08:33 AM EST

Deals

The 2021 top 100 biopharma investors: As the pandemic hit and IPOs boomed, VCs swung into action like never before

John Carroll

Editor & Founder

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

March 3, 2021 10:48 AM EST

R&D

Coronavirus

GSK, Vir's hopes for a Covid-19 antibody fall flat in NIH 'master protocol' with no benefit in hospitalized patients

Kyle Blankenship

Managing Editor

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Cedric Francois, Apellis CEO (Apellis)

March 4, 2021 04:51 PM EST

R&D

Coronavirus

Apellis joins the growing number of biopharmas scrapping a failed Covid-19 program after an early flop

John Carroll

Editor & Founder

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

March 4, 2021 09:11 AM EST

Coronavirus

Manufacturing

Novartis pairs up with CureVac to help drive Covid-19 shot production but may miss the show in the US, EU

Kyle Blankenship

Managing Editor

With the pandemic potentially entering its later stages, major drugmakers like Merck have jumped in to aid in the gargantuan task of manufacturing other companies’ vaccines. Now, after a relatively quiet year, Novartis is teaming up with one of the mRNA players to help the production crunch.

Novartis will help manufacture bulk drug substance for CureVac’s mRNA-based Covid-19 shot, dubbed CVnCoV, at its Kundl, Austria site with plans to produce up to 50 million doses by the end of 2021, the Swiss drugmaker said Thursday.

March 4, 2021 08:27 AM EST

Cell/Gene Tx

Manufacturing

In the latest big investment in gene therapy manufacturing, Biogen commits $200M to a major new facility in NC

John Carroll

Editor & Founder

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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March 4, 2021 07:12 AM EST

Coronavirus

Covid-19 roundup: EMA starts rolling review of Russia's Sputnik V; Novavax says shot is 51% effective against variant in South Africa

Amber Tong

Senior Editor

The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.

Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.

March 4, 2021 06:45 AM EST

R&D

Eli Lilly claims a TKO in its long-running title fight with Novo Nordisk for the blockbuster diabetes market — but there’s a hitch

John Carroll

Editor & Founder

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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