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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Per­cep­tive's fourth — yes, fourth — SPAC jumps to Nas­daq as the blank check tree con­tin­ues to ripen

The biotech SPAC boom has gone almost hand-in-hand with the industry’s IPO gold rush, and this week saw more blank check companies hop aboard the train.

Leading the way is Perceptive Advisors’ fourth SPAC, appropriately named Arya Sciences Acquisition IV, which priced Friday morning after raising $130 million. And on top of that, new Ziopharm executive chair James Huang is launching his own SPAC with MSD Partners and Panacea Venture, filing S-1 paperwork Thursday with plans to raise $200 million.

CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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