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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

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Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.