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.

 

 

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,500+ biopharma pros reading Endpoints daily — and it's free.

Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.