SutroVax rais­es $64M with plans to chal­lenge Pfiz­er’s megablock­buster Pre­vnar 13 for the heavy­weight ti­tle in vac­cines

SutroVax CEO Grant Pick­er­ing

When SutroVax was spun out of Sutro about four years ago, the biotech took along a con­ju­ga­tion plat­form that was re­pur­posed for de­vel­op­ing a new brand of vac­cines. And now that they are aim­ing for the clin­ic with a lead pneu­mo­coc­cal vac­cine, SutroVax has reeled in a whop­ping $64 mil­lion raise to get them well in­to hu­man stud­ies for a new vac­cine that will chal­lenge the megablock­buster Pre­vnar 13 for the heavy­weight ti­tle in its field.

The big idea be­hind the con­ju­ga­tion tech at SutroVax is that the biotech be­lieves it can more ef­fec­tive­ly stitch to­geth­er anti­gens to a car­ri­er pro­tein that can ul­ti­mate­ly tar­get a laun­dry list of bac­te­ria while amp­ing up a T cell re­sponse di­rect­ed at the tar­get.

Pre­vnar 13 is a con­ju­gat­ed vac­cine which goes af­ter 13 strains of Strep­to­coc­cus pneu­mo­ni­ae. It al­so earned about $6 bil­lion last year, which is why some up­starts like Affini­vax in Cam­bridge, MA are al­so look­ing at new and dif­fer­ent ways to bind mul­ti­ple poly­sac­cha­rides to pro­teins and do Pre­vnar 13 mul­ti­ple strains bet­ter. (Affini­vax us­es a dif­fer­ent plat­form tech, steer­ing clear of tra­di­tion­al con­ju­ga­tion.)

“If you could have Pre­vnar 24,” says SutroVax CEO Grant Pick­er­ing, “that would be the best case sce­nario. That is what we are look­ing to do.” And SutroVax is us­ing a con­ven­tion­al ap­proach that’s tweaked to great­ly broad­en its ef­fec­tive­ness.

“We took a prag­mat­ic ap­proach when we set out to put this pro­gram to­geth­er,” says Pick­er­ing. “The re­al­i­ty is that Pre­vnar is a phe­nom­e­nal vac­cine. It’s wild­ly ef­fec­tive, but not as broad spec­trum as peo­ple would like it.”

Half of the strains aren’t cov­ered, which is why some pa­tients are giv­en Pre­vnar 13 with Pneu­movax, “an in­fe­ri­or” vac­cine, in Pick­er­ing’s view. In­stead of try­ing to stitch all the anti­gens it needs to a sin­gle car­ri­er pro­tein, though, SutroVax is mak­ing mul­ti­ple vac­cines that can go af­ter all the strains, us­ing the tra­di­tion­al con­ju­ga­tion method but do­ing it in a way that leaves the car­ri­er pro­tein bet­ter equipped to gen­er­ate the T cell re­sponse.

“We can put the poly­sac­cha­ride on the same car­ri­er, in the same site spe­cif­ic lo­ca­tion every time,” he adds. By keep­ing the same pre­cise re­gion of the pro­tein ex­posed to the im­mune sys­tem, they be­lieve they can gen­er­ate a strong im­mune re­sponse while us­ing less of the pro­tein car­ri­er in each of the vac­cines in­volved.

And they’ve been run­ning tests on rab­bits, the pre­ferred an­i­mal mod­el, to prove their point.

Mak­ing 24 vac­cines is no sim­ple task, and SutroVax isn’t plan­ning to jump in­to the clin­ic overnight. The IND is like­ly go­ing to ar­rive in 2019, says Pick­er­ing.

Fra­zier Health­care Part­ners and the brand new biotech fund Piv­otal bioVen­ture Part­ners led the round, join­ing a syn­di­cate that in­clud­ed par­tic­i­pa­tion from all ex­ist­ing in­vestors: Abing­worth, Lon­gi­tude Cap­i­tal, Roche Ven­ture Fund and CTI Life Sci­ences Fund. The ex­ist­ing in­vestors al­so chipped in $4 mil­lion, on top of the $60 mil­lion round, to com­plete their Se­ries A com­mit­ments. And Pick­er­ing says the to­tal raised so far now comes to $88 mil­lion, a sub­stan­tial bet in the vac­cine field.

With the mon­ey, the Bay Area biotech will now about dou­ble its cur­rent staff of 14 — which al­so re­lies on a line­up of con­sul­tants to flesh out the or­ga­ni­za­tion.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.