As­traZeneca spins out 6 drugs and an R&D group in­to Viela Bio, which emerges with a piv­otal pro­gram and $250M

As­traZeneca $AZN has culled its pipeline of pre­clin­i­cal through mid-stage an­ti-in­flam­ma­to­ry/au­toim­mune drugs at its big Med­Im­mune sub­sidiary in Gaithers­burg, MD and spun out six pro­grams in­to a new start­up called Viela Bio.

Viela springs in­to ex­is­tence to­day with the sup­port of a group of three mar­quee Chi­nese in­vestors who have put up $250 mil­lion to get the com­pa­ny es­tab­lished and keep all its pro­grams mov­ing for­ward un­in­ter­rupt­ed. And As­traZeneca is re­tain­ing the largest sin­gle mi­nor­i­ty stake in the com­pa­ny as it bids farewell to a group of in­ves­ti­ga­tors who have di­rect­ed this work in­side Med­Im­mune for years.

Bing Yao, the head of Med­Im­mune’s Res­pi­ra­to­ry, In­flam­ma­tion & Au­toim­mu­ni­ty In­no­v­a­tive Med­i­cines unit, is tak­ing the helm as CEO. An­oth­er As­traZeneca vet in the RIA unit, Jorn Drap­pa, will be the new chief med­ical of­fi­cer and R&D chief.

Bahi­ja Jal­lal

Yao told me in a pre­view of to­day’s an­nounce­ment that they’re still in the process of re­view­ing who at Med­Im­mune will come along. But Med­Im­mune chief Bahi­ja Jal­lal — who em­pha­sized the phar­ma gi­ant’s com­mit­ment to as­sist­ing the biotech ecosys­tem in Mary­land — says there will be no lay­offs, with some mak­ing the jump to Viela and the rest of the peo­ple at­tached to these pro­grams be­ing as­signed to oth­er projects.

“We al­ways run lean here,” says Jal­lal, so there’s no short­age of work for those who re­main. The de­part­ing group have plen­ty on their plate as well.

“It’s a rich pipeline,” says Yao, cit­ing a lead drug — inebi­lizum­ab — that’s in a po­ten­tial­ly reg­is­tra­tional Phase IIb study for a rare con­di­tion called neu­romyelitis op­ti­ca. Both the FDA and the EMA have en­dorsed the work with or­phan drug sta­tus. The oth­er two clin­i­cal pro­grams are ME­DI4920, an an­ti-CD40L-Tn3 fu­sion pro­tein for an in­flam­ma­to­ry con­di­tion called pri­ma­ry Sjö­gren’s syn­drome, and ME­DI7734 for myosi­tis.

The con­sor­tium of in­vestors in­cludes Boyu Cap­i­tal, 6 Di­men­sions Cap­i­tal and Hill­house Cap­i­tal, which all met Yao’s cri­te­ria: Deep pock­ets, a longterm view of things and a big ap­petite for biotech. Boyu is an in­flu­en­tial pri­vate eq­ui­ty group that al­so backed Greg Ver­dine’s LifeM­ine. And Wuxi Health­care Ven­tures threw in with Front­line BioVen­tures to cre­ate 6 Di­men­sions in a merg­er last year.

In the long run, says the new­ly mint­ed CEO, these are the kind of back­ers that will help build a staff of 100 over the next few years, while al­so as­sist­ing as Viela be­gins the ear­ly work of scout­ing the com­mer­cial prospects of its lead ther­a­py. Viela, he says, can go all the way in be­com­ing a ful­ly in­te­grat­ed biotech com­pa­ny.

As­traZeneca has been shed­ding as­sets for years now as it con­cen­trates its R&D cash around three key fields: On­col­o­gy first and fore­most fol­lowed by car­dio/meta­bol­ics and res­pi­ra­to­ry. The clin­i­cal stage drugs be­ing spun out to­day have been list­ed with the re­main­der of the neu­ro­sciences pro­grams as the “oth­er” cat­e­go­ry of work be­ing done at As­traZeneca, and ex­ecs em­pha­sized that they’re re­tain­ing the Phase III lu­pus drug an­i­frol­um­ab, where they have high hopes of suc­cess.

A spin­out like this, says Jal­lal, is a nat­ur­al re­sult when you have a rich pipeline like As­traZeneca’s, where there are more drugs to de­vel­op than it can han­dle alone.

 

 

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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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.

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.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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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.

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.

New biotech Exalys, seek­ing to pre­vent post­op­er­a­tive delir­i­um, launch­es with $15 mil­lion in Se­ries A

An old group of former colleagues will be reuniting to lead a new biotech venture aimed at cultivating a portfolio to treat neuroinflammatory disorders.

Led by Rick Orr, who ran the biotech Adynxx, the group is launching the startup Exalys on Thursday with $15 million in Series A funding from venture firms Catalys Pacific and Domain Associates. The nascent company’s first project will focus on preventing postoperative delirium, licensing a platform of EP4 receptors from Japanese pharma Eisai.

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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.