As­traZeneca's star res­pi­ra­to­ry drug runs in­to an­oth­er wall with COPD, but it's not giv­ing up — yet

As­traZeneca’s at­tempt to push its res­pi­ra­to­ry bi­o­log­ic Fasen­ra (ben­ral­izum­ab) in­to the chron­ic ob­struc­tive pul­monary dis­ease field has been foiled by a Phase III flop.

Sean Bo­hen

In the 56-week mul­ti-cen­ter tri­al, Fasen­ra failed to spur a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of ex­ac­er­ba­tions in pa­tients with mod­er­ate to very se­vere COPD, the pri­ma­ry end­point, com­pared to place­bo.

Cur­rent­ly ap­proved as an add-on treat­ment for se­vere eosinophilic asth­ma in the US, EU, Japan and sev­er­al oth­er coun­tries, Fasen­ra was billed as a block­buster in the mak­ing, with CEO Pas­cal So­ri­ot es­ti­mat­ing peak sales po­ten­tial at $2 bil­lion (Jef­feries an­a­lysts gave it a more mod­est $1.5 bil­lion).

To achieve that, As­traZeneca need­ed to nav­i­gate a mar­ket al­ready staked by Glax­o­SmithK­line’s first-in-class Nu­cala, Te­va’s Cinqair, and No­var­tis’ Xo­lair. It’s too ear­ly to tell whether its com­bi­na­tion of low­er pric­ing, dos­ing fre­quen­cy and de­liv­ery method was enough to start win­ning over large num­bers of physi­cians and pa­tients, and its more en­trenched ri­vals are plan­ning moves of their own. Last Sep­tem­ber, GSK fol­lowed up with an NDA for Nu­cala in COPD — though the case was al­so built up­on shaky da­ta heav­i­ly re­liant on a bio­mark­er.

As­traZeneca went in­to the Phase III Galathea study (as well as an­oth­er one dubbed Ter­ra­no­va) de­spite con­ced­ing de­feat in a PhI­Ia study back in 2014, where Fasen­ra not on­ly failed to im­prove the rate of acute ex­ac­er­ba­tions for se­vere COPD pa­tients but al­so saw a high­er rate of treat­ment-emer­gent ad­verse events. Ex­ecs at the UK phar­ma gi­ant and its bi­o­log­ics unit Med­Im­mune were bet­ting that bet­ter tri­al de­sign and pa­tient se­lec­tion would de­liv­er a des­per­ate­ly need­ed win in this key dis­ease tar­get, but it proved elu­sive.

That said, no new safe­ty or tol­er­a­bil­i­ty is­sues were re­port­ed in this tri­al — per­haps the on­ly good news in the an­nounce­ment.

While the team is still crunch­ing the num­bers for an up­com­ing med­ical meet­ing, CMO Sean Bo­hen has this to say:

COPD is a de­bil­i­tat­ing dis­ease with sig­nif­i­cant un­met need among pa­tients whose dis­ease re­mains un­con­trolled de­spite treat­ment with ex­ist­ing in­haled ther­a­pies. We will now await the re­sults of TER­RA­NO­VA and a full eval­u­a­tion of both tri­als to de­ter­mine next steps for Fasen­ra in COPD.

Ter­ra­no­va is sched­uled to read out this quar­ter.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.