SutroVax lands an­oth­er $100M+ in up­start quest against Pfiz­er’s block­buster Pre­vnar 13

For the last half-decade, in a fa­cil­i­ty just south of South San Fran­cis­co, the spin­off of a small Stan­ford spin­out has been qui­et­ly gun­ning for Pfiz­er and the world’s most lu­cra­tive vac­cine mar­ket. Now, they say they’re ready (al­most).

SutroVax an­nounced a $110 mil­lion Se­ries D fi­nanc­ing that will help take the com­pa­ny and its ri­val to Pfiz­er’s block­buster pneu­mo­coc­cal vac­cine Pre­vnar 13 in­to the clin­ic, al­though not un­til 2021. Hav­ing slow­ly amassed a long list of A-list in­vestors since their J&J-backed 2013 launch, the biotech added RA Cap­i­tal Man­age­ment and Janus Hen­der­son In­vestors this round to go along with all their in­sti­tu­tion­al back­ers.

Pre­vnar 13, first ap­proved in 2011, has be­come a $6 bil­lion-per-year vac­cine and tak­en on in­creased rel­e­vance since the start of the pan­dem­ic, po­ten­tial­ly help­ing guard against the pneu­mo­nia Covid-19 can in­duce.

Grant Pick­er­ing

“Giv­en how mas­sive the pneu­mo­coc­cal mar­ket is, it’s hard to imag­ine any­thing be­ing as at­trac­tive from a rev­enue per­spec­tive,” SutroVax founder and CEO Grant Pick­er­ing told End­points News. “We cer­tain­ly feel like we made the right first choice, but the good news is we think there are some oth­er ap­pli­ca­tions we think will al­so be very im­por­tant.”

The tech­nol­o­gy at the base of the com­pa­ny is the plat­form of Mer­ck-part­nered can­cer biotech Sutro Bio­phar­ma, al­though the lat­est fund­ing round means SutroVax has raised more cash — near­ly $300 mil­lion — in 7 years than its par­ent has in 17 years. Sutro had fig­ured out a way to de­sign and man­u­fac­ture pro­teins with­out us­ing liv­ing cells, as bi­ol­o­gists have for decades. They used to build an­ti­body-drug con­ju­gates and re­cent­ly brought mul­ti­ple in­to the clin­ic. They re­al­ized, though, that it could al­so be im­por­tant for build­ing vac­cines, a field whose po­ten­tial had long been lim­it­ed by how pre­cise­ly you could de­sign a pro­tein.

“It pro­vid­ed an op­por­tu­ni­ty to take ad­van­tage of this plat­form that had al­ready been quote-un-quote ‘in­dus­tri­al­ized,’” Pick­er­ing said. “They had al­ready scaled it up.”

Ear­ly on, they set out on pneu­mo­coc­cal vac­cines. It had three dis­tinct ad­van­tages: The mar­ket was huge; be­cause it in­volved not on­ly build­ing a pro­tein but ty­ing that pro­tein to a sug­ar, it was a poor tar­get for oth­er new vac­cine tech­nolo­gies, such as mR­NA; and re­searchers had long want­ed to add new strains of bac­te­ria to the vac­cine but have been lim­it­ed by con­ven­tion­al ap­proach­es.

Pfiz­er’s pneu­mo­coc­cal vac­cine is a con­ju­gate — a blend of pro­phy­lac­tics against dif­fer­ent strains — that guards against 13 of the 30 pneu­mo­coc­cal bac­te­ria strains that cause dis­ease in hu­mans, Pick­er­ing said. But its suc­cess against those strains has opened a win­dow for the oth­er 17 to prop­a­gate and cause in­fec­tion. They now ac­count for the ma­jor­i­ty of cas­es of pneu­mo­nia.

Pfiz­er and oth­er com­pa­nies are ac­tive­ly try­ing to add new strains to the mix. Pick­er­ing, though, said those com­pa­nies have strug­gled be­cause con­ju­gate vac­cines re­ly on a form of diph­the­ria tox­in to ac­ti­vate the im­mune sys­tem. The more bac­te­ria you try to guard against, the more diph­the­ria you need and, para­dox­i­cal­ly, that diph­the­ria be­gins to ba­si­cal­ly com­pete for im­mune cells and pre­vents the body from build­ing an­ti­bod­ies to the bac­te­ria.

”It’s rob­bing the mem­o­ry cells from be­ing able to be there for the [bac­te­ria pro­teins],” Pick­er­ing said. “It’s called car­ri­er sup­pres­sion.”

Pick­er­ing said SutroVax’s plat­form en­ables them to de­sign pro­teins in a unique way to avoid this prob­lem. They grow E. Coli and then es­sen­tial­ly suck out the cel­lu­lar ma­chin­ery from them. Sep­a­rat­ed from the bac­te­ria, that ma­chin­ery can then be fed with non-na­tive amino acids and in­duced to build pro­teins an E.Coli nev­er could. SutroVax de­signs these pro­teins in such a way that the vac­cine re­quires less diph­the­ria and in pre­clin­i­cal stud­ies, they said, it guard­ed against 24 strains with­out low­er­ing the over­all im­mune re­sponse.

They’ll have a high bar to clear, though. Pfiz­er just hit its mark in a late-stage tri­al of its own suc­ces­sor vac­cine, guard­ing against 19 dif­fer­ent strains out of a goal of 20. Mer­ck is al­so in Phase III on a vac­cine against 15 strains.

Pick­er­ing said their time­lines have yet to be af­fect­ed by Covid-19, al­though they have in­sti­tut­ed shift work in their lab.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Sanofi and GSK reach deal with Cana­da for 72 mil­lion vac­cine dos­es

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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