Covid-19 roundup: Af­ter bat­ting back at vac­cine sup­pli­er, In­ovio lines up a gi­ant in its cor­ner; Ox­ford spin­out Spy­Biotech be­gins PhI/II dos­ing for VLP-based vac­cine

In­ovio an­nounced Tues­day morn­ing that man­u­fac­tur­ing gi­ant Ther­mo Fish­er has signed on to make their Covid-19 vac­cine INO-4800 in 2021. The biotech — which has yet to get an OK on a vac­cine af­ter more than 40 years of op­er­a­tions — ex­pects to be able to dis­trib­ute 100 mil­lion dos­es to help end the Covid-19 pan­dem­ic, but first it has to get around a re­cal­ci­trant man­u­fac­tur­er that con­trols much of the IP used to make the biotech’s vac­cines.

In­ovio, nev­er shy about ac­cept­ing brag­ging rights, likes to note that its DNA plat­form ap­proach to this mas­sive prob­lem can be ad­dressed with a jab that doesn’t have to stay in the same freez­ing cold sup­ply chain re­quired by Pfiz­er/BioN­Tech and Mod­er­na. That’s a ma­jor dif­fer­en­ti­a­tion — pro­vid­ed it can make it to the mar­ket in time to ri­val the fron­trun­ners.

In­ovio plans to start a late-stage study of their vac­cine this month, pro­vid­ed reg­u­la­tors sign off. That puts them well be­hind a group of lead­ers, with Pfiz­er out front with a promise to prove whether their mR­NA vac­cine from BioN­Tech works some­time next month.

A big road­block al­so still lies along the man­u­fac­tur­ing lane.

A few months ago a frus­trat­ed In­ovio CEO Joseph Kim com­plained that their man­u­fac­tur­er was in­ca­pable of mak­ing com­mer­cial quan­ti­ties and re­fused to trans­fer the IP nec­es­sary for oth­ers to do so. The com­pa­ny launched a bit­ter le­gal bat­tle with VGXI, and a spokesper­son for In­ovio tells me to­day that the lit­i­ga­tion is on­go­ing. He added that their at­tempt to gain an in­junc­tion was de­nied by the judge.

In­ovio’s stock is up 10% Tues­day morn­ing. — John Car­roll

A ‘plug and dis­play’ VLP play­er takes a shot at ear­ly-stage Covid-19 vac­cine

A re­cent Ox­ford spin­out has be­gun a new Covid-19 vac­cine tri­al, and is tak­ing a bit of a dif­fer­ent ap­proach than most oth­er play­ers.

Spy­Biotech has launched a Phase I/II tri­al with the Serum In­sti­tute of In­dia as a new part­ner, test­ing whether or not its virus-like-par­ti­cle-based vac­cine can prove safe and ef­fec­tive. They an­nounced the first dos­ing of its pa­tients Tues­day. The Serum In­sti­tute of In­dia is run­ning clin­i­cal de­vel­op­ment of the study, which will take place in Aus­tralia, and li­censed Spy­Biotech’s VLP tech­nol­o­gy. Fi­nan­cial terms of the deal were not dis­closed.

Su­mi Biswas

“Tra­di­tion­al­ly speak­ing, ge­net­i­cal­ly fus­ing large, com­plex anti­gens with VLPs is ex­treme­ly dif­fi­cult,” CEO and co-founder Su­mi Biswas told End­points News. “With our tech­nol­o­gy, we’ve cre­at­ed this plat­form … which lets you plug and dis­play dif­fer­ent pathogen anti­gens.”

Right now, the com­pa­nies have re­cruit­ed “a few hun­dred” vol­un­teers, Biswas said, and are re­search­ing how safe the can­di­date can be at dif­fer­ent dos­es. It will be con­trolled against an ad­ju­vant.

The com­pa­ny’s plat­form us­es what Biswas called “su­per­glue” pro­tein tech­nol­o­gy that is de­rived from the strep fam­i­ly, split­ting pro­teins in­to two parts — termed Spy­Catch­er and Spy­Tag. De­spite the di­vi­sion, they re­tain their at­trac­tive­ness and al­low Spy­Biotech to fuse them to oth­er plat­forms and dec­o­rate them with VLPs.

In terms of its Covid-19 vac­cine can­di­date, Spy­Biotech is bas­ing its ef­forts off the he­pati­tis B vac­cine, split­ting the pro­tein to dis­play the coro­n­avirus spike rather than the hep B anti­gen. At­tempt­ing to take ad­van­tage of the hep B vac­cine’s safe­ty pro­file, Biswas is con­fi­dent in the com­pa­ny’s ef­forts giv­en its suc­cess at pre­sent­ing oth­er anti­gens on the same VLP in oth­er proof-of-con­cept stud­ies.

“The dis­play­ing process is very sim­ple, and we have used the same he­pati­tis B VLP with that Spy­Catch­er to dis­play a lot of com­plex anti­gens,” Biswas said. “What we’ve done dif­fer­ent­ly for this is that, of course, the anti­gen is dif­fer­ent, it’s the same Spy­Tag and you es­sen­tial­ly mix the two and you’ve got very good dis­play of the anti­gen on the sur­face of the VLP.”

Mov­ing for­ward, Biswas said she ex­pects da­ta from the tri­al to come in some­time in Oc­to­ber or No­vem­ber, and hopes to start the Phase III study be­fore the end of the year.

Spun out of Ox­ford in 2017, Spy­Biotech was ini­tial­ly based on re­search in­to the “su­per­glue” phe­nom­e­non that showed promis­ing re­sults for a malar­ia vac­cine. Since then, the biotech has fo­cused main­ly on its lead pro­gram, a vac­cine can­di­date for hu­man cy­tomegalovirus pro­ject­ed to start Phase I late next year.

Biswas hopes the tech­nol­o­gy will be use­ful in oth­er in­di­ca­tions too, as Spy­Biotech has seen ear­ly pos­i­tive re­sults in on­col­o­gy and oth­er in­fec­tious dis­eases. But right now, the man­u­fac­tur­ing ad­van­tage that VLPs have over oth­er Covid-19 vac­cine can­di­dates gives Spy­Biotech a leg up on the com­pe­ti­tion, Biswas says.

“The fact that the VLP car­ri­er can be man­u­fac­tured in large quan­ti­ties and kept, and that man­u­fac­tur­ing can be worked out in ad­vance, it makes it suit­able for use in these sit­u­a­tions,” Biswas said. “In the un­for­tu­nate sit­u­a­tion of Covid, at large, this is def­i­nite­ly even an ac­cel­er­at­ed proof point for that plat­form, and we’re re­al­ly look­ing for­ward to ex­ploit­ing this in oth­er dis­eases.” — Max Gel­man

Mod­er­na slows down Phase III en­roll­ment to en­sure di­ver­si­ty

One of the lead­ers in the Covid-19 vac­cine race has re­port­ed­ly de­cid­ed to pump the brakes slight­ly on its Phase III tri­al en­roll­ment.

Mod­er­na CEO Stéphane Ban­cel told CN­BC in an in­ter­view Fri­day that the com­pa­ny would be de­cel­er­at­ing en­roll­ment in or­der to en­sure that mi­nor­i­ty com­mu­ni­ties most at risk from the virus are suf­fi­cient­ly rep­re­sent­ed in the tri­al. As of Fri­day, about 20% of par­tic­i­pants are His­pan­ic or Lati­no and around 7% are Black, Mod­er­na re­port­ed.

“We be­lieve we could have one of the best vac­cines,” Ban­cel told CN­BC. “We want to en­sure we have da­ta for all the peo­ple who could ben­e­fit and be pro­tect­ed.”

Ban­cel added that Mod­er­na’s goal is for the tri­al pop­u­la­tion to match US Cen­sus num­bers, which es­ti­mat­ed in 2019 that around 18.5% of Amer­i­cans are His­pan­ic or Lati­no, while 13.4% are Black.

In­vestors re­act­ed poor­ly to the com­ments, send­ing the stock down around 8% im­me­di­ate­ly af­ter­ward, but then re­cov­er­ing to fin­ish Fri­day down about 3.5%. In trad­ing over the ex­tend­ed La­bor Day week­end, Mod­er­na was down an­oth­er 4%.

Since the start of the year, Mod­er­na shares have risen over 225%. Ban­cel has re­port­ed sell­ing more than $40 mil­lion of his own stock over that time pe­ri­od. The com­pa­ny an­nounced last Fri­day evening that it had en­rolled more than 6,000 new vol­un­teers in its Phase III tri­al over the pre­vi­ous week, bring­ing the to­tal num­ber to 21,411 out of an ex­pect­ed 30,000.

Pfiz­er, the on­ly com­peti­tor ahead of Mod­er­na in End­points News‘ Covid-19 vac­cine race track­er, is up to about 23,000 en­rolled pa­tients in its Phase III, CEO Al­bert Bourla said last Thurs­day. That tri­al has re­port­ed 25% His­pan­ic or Lati­no vol­un­teers and 8% Black vol­un­teers. The com­pa­ny has said pub­licly that da­ta could be avail­able by the end of Oc­to­ber, a pro­jec­tion on which Warp Speed chief Mon­cef Slaoui threw cold wa­ter. — Max Gel­man

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Paul Stoffels, J&J CSO (Andrew Harnik/AP Images)

J&J on track to roll out sin­gle-shot Covid-19 vac­cine in March, Paul Stof­fels con­firms, al­though man­u­fac­tur­ing de­lays raise ques­tions

We should know how effective J&J’s Covid-19 vaccine — the single shot that’s closest to potential authorization — is by the end of this month or early February.

CSO Paul Stoffels added that they are on track to roll out the vaccine in March, just as the pharma giant published Phase I/IIa results in the New England Journal of Medicine. But a New York Times report also raises doubts about how many it can actually deliver in spring, citing unanticipated manufacturing delays.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.

Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.