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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

David Coman, Science 37

Amid vir­tu­al tri­al craze, Sci­ence 37 earns uni­corn sta­tus and a trip to Nas­daq on the back of SPAC deal

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As the Covid-19 pandemic made conventional trials impossible for some drugmakers, more and more companies moved to decentralize their clinical studies, accelerating business for tech developers like Science 37. Leveraging that boost, the company is on the verge of a SPAC merger, landing unicorn status and its very own stock ticker.