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.

 

 

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.

David Halbert, Caris Life Sciences CEO (Caris via Twitter)

The grow­ing liq­uid biop­sy field sees a uni­corn en­trant as Caris pulls in $830M megaround

Caris Life Sciences has pulled in another massive raise, and this time they’re reportedly one step closer to launching their IPO.

The AI-focused Caris pulled in an $830 million growth equity round, the company announced Tuesday afternoon, earning a valuation of about $7.83 billion. Tuesday’s raise also brings their total financing amount to $1.3 billion since 2018 and $1.14 billion since last October. According to the Wall Street Journal, which first reported on the raise, Caris expects to complete their IPO sometime within the next 12 months.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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