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.

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Covid-19 roundup: Sanofi and GSK pledge 200 mil­lion vac­cine dos­es for a glob­al dis­tri­b­u­tion cam­paign

Sanofi and GSK have agreed to give 200 million doses of their vaccine candidate to the COVAX Facility, which is part of a program set up by CEPI, the WHO and Gavi to equitably distribute vaccines around the world.

The idea behind COVAX is to give all participating countries equal access to vaccines, regardless of income level. As of Oct 14, more than 180 countries had signed agreements to the COVAX Facility, including France and the UK. China joined earlier this month, pledging to make its vaccines a “global public good.” One country notably off the list is the United States.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Yung Chyung, Scholar Rock CMO (Business Wire)

A dark horse en­trant in­to the spinal mus­cu­lar at­ro­phy field dou­bles its val­ue on some PhII da­ta

The last four years have seen a sudden explosion in treatments for spinal muscular atrophy, a neurodegenerative condition that once led patients — often young ones — with a grim prognosis and no options. The prognosis still isn’t rosy, but now there are three FDA-approved options, enough to make the choice of one difficult.

Now a fourth potential option has entered the mix. Today, Scholar Rock announced the results from a proof-of-concept testing their SMA drug by itself and in combination with Ionis’ Spinraza, showing that all patient cohorts improved on standard scales used for measuring motor function in people with SMA.