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.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.