Bing Yao. Viela Bio

On track for first au­toim­mune drug ap­proval, Bing Yao steers As­traZeneca spin­off to $150M IPO

Just days af­ter Viela Bio se­cured its first PDU­FA date for its lead au­toim­mune drug, the As­traZeneca spin­off is con­fi­dent­ly gun­ning for a $150 mil­lion IPO.

The biotech is ded­i­cat­ing most of the pro­ceeds to three as­sets — out of six it got from a cleanup at Med­Im­mune be­fore the bi­o­log­ics unit got re­struc­tured al­to­geth­er. Chief among them would be inebi­lizum­ab, the an­ti-CD19 drug that’s be­ing ush­ered through the BLA ap­proval process for neu­romyelitis op­ti­ca spec­trum dis­or­der, prepped for com­mer­cial­iza­tion and ex­plored in ad­di­tion­al in­di­ca­tions. Then there’s al­so the CD40L-tar­get­ing VIB4920, for which Phase II stud­ies are planned for lat­er this year; and the Phase Ib an­ti­body VIB7734, which in­hibits ILT7.

One of the pro­grams from Med­Im­mune, though, seem­ing­ly did not make the cut in­to their pipeline, ac­cord­ing to the S-1.

Viela Bio has moved fast since its $250 mil­lion launch in Feb­ru­ary 2018, splash­ing $216.7 mil­lion to-date while pick­ing up a $75 mil­lion Se­ries B along the way. That leaves CEO Bing Yao with $189 mil­lion in cash and cash equiv­a­lents — with the new in­fu­sion of cash, the run­way will ex­tend to 2022.

The com­mer­cial team field­ing inebi­lizum­ab for NMOSD will be fac­ing an en­trenched rare dis­ease ri­val in Alex­ion, which just re­cent­ly won an ex­pand­ed la­bel for Soliris. In­stead of hit­ting the B cells se­cret­ing au­toan­ti­bod­ies, Soliris blocks the sub­se­quent ac­ti­va­tion of the com­ple­ment sys­tem. Roche/Chugai’s satral­izum­ab was al­so list­ed as po­ten­tial com­pe­ti­tion.

But for Viela Bio, the val­ue of inebi­lizum­ab lies in its po­ten­tial to ad­dress a slate of dis­eases. They will put that hy­poth­e­sis to test in up­com­ing mid- and late-stage tri­als for kid­ney trans­plant de­sen­si­ti­za­tion, myas­the­nia gravis and IgG4-re­lat­ed dis­or­ders.

In its SEC fil­ing, the com­pa­ny al­so laid out just how ex­ten­sive its ties with As­traZeneca are. In ad­di­tion to a 38.4% stake, the phar­ma gi­ant has mul­ti­ple agree­ments in place to sup­ply clin­i­cal and com­mer­cial drug sub­stances and prod­ucts to Viela Bio. And that’s not to men­tion Yao’s top team, as well as a sig­nif­i­cant por­tion of the R&D crew, had mi­grat­ed from Med­Im­mune.

Dur­ing his first year, Yao took home a com­pen­sa­tion pack­age worth more than $2.4 mil­lion, in­clud­ing $936,047 in stock awards and $895,500 in op­tion awards. Jörn Drap­pa, who heads R&D, comes in next with $1.3 mil­lion; BD chief Aaron Ren was re­ward­ed with $747,032 to­tal; while CFO Mitchell Chan got $402,617.

The close re­la­tion­ship al­so means Viela Bio in­her­it­ed a num­ber of li­cens­ing pacts from Med­Im­mune, which en­tail mile­stone and roy­al­ty pay­ments to Duke Uni­ver­si­ty, SBI Biotech, Dana-Far­ber Can­cer In­sti­tute, BioWa and Lon­za.

Aside from As­traZeneca Sean Tong of Boyu Cap­i­tal (who’s al­so on Viela Bio’s board) and Bound­less Mead­ow Lim­it­ed claim the largest chunk of shares, each at 18.4%. Ed­ward Hu of WuXi (9.2%), 6 Di­men­sions (9.2% to­tal), HH RSV-MIM Hold­ings (9.2%) and TLS Be­ta (7.6) fol­low.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

Endpoints Premium

Premium subscription required

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

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”