Tilt­ing at vac­cines gi­ants, SutroVax fu­els up on a $170M-plus quest to vault past the world's best-sell­ing vac­cine

A lit­tle biotech tilt­ing against gi­ants in the glob­al vac­cines busi­ness has just lined up an $85 mil­lion round to back their clin­i­cal quest aimed at con­quer­ing the pneu­mo­coc­cal con­ju­gate vac­cine busi­ness. And they’ve added crossover in­vestors — as well as a world-fa­mous vac­cines hon­cho — in the round as they con­tin­ue to plot out a risky path for­ward in­to a mega-block­buster mar­ket.

Grant Pick­er­ing

Glax­o­SmithK­line’s ex-vac­cines chief Mon­cef Slaoui is com­ing on board as chair­man of SutroVax as the Fos­ter City, CA-based biotech push­es past the $170 mil­lion mark on fundrais­ing. All that mon­ey, plus every­thing to come, is rid­ing on the be­lief that the Sutro spin­out has re­li­able tech that can whip up a first-in-class prod­uct that con­ju­gates a big clus­ter of anti­gens to site-spe­cif­ic lo­ca­tions on a pro­tein car­ri­er with­out hob­bling T-cell helpers, build­ing a bet­ter vac­cine the gi­ants can’t touch.

CEO Grant Pick­er­ing tells me much of the new mon­ey will be used to line up the man­u­fac­tur­ing work that will be need­ed as they be­gin to test their vac­cine for pneu­mo­coc­cal pneu­mo­nia in hu­mans. 

Right now, that mar­ket is dom­i­nat­ed by Pfiz­er’s $6 bil­lion a year prod­uct Pre­vnar 13, which upped the ante on pneu­mo­coc­cus strains that can be guard­ed against. Pre­vnar 13 is the world’s best-sell­ing vac­cine. Mer­ck just start­ed a late-stage pro­gram for V114 that hopes to shove Pfiz­er aside with a new prod­uct that takes that to 15. And SutroVax says it can go past the 20 mark us­ing tech for a con­ju­gate vac­cine that no oth­er com­pa­ny can ri­val.

“Hav­ing just a few more strains re­al­ly is a sig­nif­i­cant com­pet­i­tive ad­van­tage,” says Pick­er­ing, who is hop­ing to vault the gi­ants with a prod­uct that can carve away bil­lions — and keep it. 

That’s not go­ing to come cheap — and cer­tain­ly won’t be easy. Pick­er­ing al­lows that the syn­di­cate was brought to­geth­er with an eye to keep­ing their op­tions open on an IPO at some point. The CEO al­so isn’t ready to lay out his de­vel­op­ment time­lines, ex­act num­ber of strains they’re plan­ning on or even when the first hu­man will be test­ed.

Why flag your en­tire plan in a com­pet­i­tive field like this?

New in­vestor TPG Growth, Medicxi and Fore­site Cap­i­tal all came on board with this round. That adds Medicxi’s Francesco de Ru­ber­tis to the group, while all of SutroVax’s ex­ist­ing in­sti­tu­tion­al in­vestors, in­clud­ing Abing­worth, Lon­gi­tude Cap­i­tal, Fra­zier Health Care Part­ners, Piv­otal bioVen­ture Part­ners, Roche Ven­ture Fund, and CTI Life Sci­ences Fund came back.

Medicxi in turn is backed by a trio of gi­ants — J&J, GSK and No­var­tis — and of­fers a “nice lens” in­to their think­ing on this pro­gram, which dom­i­nates the biotech’s time. Slaoui, who of­fered a thumbs up for the com­pa­ny’s “huge po­ten­tial,” will help with the glob­al per­spec­tive as well.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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