It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Us­ing lab-grown pro­teins that are en­gi­neered to mim­ic the ar­chi­tec­ture of virus­es to in­duce an im­mune re­sponse, VBI Vac­cines is join­ing the hunt for a coro­n­avirus vac­cine — har­ness­ing tech­nol­o­gy that has ini­tial­ly been proved safe in ear­ly tri­als as a pro­phy­lac­tic for cy­tomegalovirus (CMV) in­fec­tion.

Un­like the raft of the com­pa­nies in the Covid-19 vac­cine race — in­clud­ing Mod­er­na, Cure­Vac and J&J — VBI is tak­ing a pan-coro­n­avirus ap­proach, by de­vel­op­ing a vac­cine that will en­com­pass Covid-19, se­vere acute res­pi­ra­to­ry syn­drome (SARS), and Mid­dle East res­pi­ra­to­ry syn­drome (MERS).

Fran­cis­co Di­az-Mit­o­ma

“When you look at the evo­lu­tion of the cur­rent coro­n­avirus it has the ca­pac­i­ty to change, two to three amino acids per month. So this evo­lu­tion takes it, then, to new places that we don’t know,” VBI CMO Fran­cis­co Di­az-Mit­o­ma said in an in­ter­view. “And in or­der to cov­er this evo­lu­tion, we’re try­ing to de­vel­op a more broad-spec­trum vac­cine that will cov­er po­ten­tial­ly emerg­ing strains of coro­n­avirus.”

Ex­ist­ing vac­cines are made in many ways: They may con­tain live virus­es that have been at­ten­u­at­ed (weak­ened or al­tered so as not to in­duce ill­ness); in­ac­ti­vat­ed or killed or­gan­isms or virus­es; in­ac­ti­vat­ed tox­ins; or mere­ly seg­ments of the pathogen (this in­cludes both sub­unit and con­ju­gate vac­cines).

VBI is em­ploy­ing the sub­unit ap­proach, in which pro­tein struc­tures de­signed to mim­ic the virus are en­gi­neered in the lab, but with­out the vi­ral genome, to in­duce im­mu­ni­ty. Un­like live-at­ten­u­at­ed vac­cines, these “virus-like par­ti­cles (VLPs)” can­not re­vert back to an in­fec­tious state.

The com­pa­ny — which al­ready sells a Hep B vac­cine and has re­port­ed pos­i­tive ear­ly-stage da­ta on its ex­per­i­men­tal CMV vac­cine — is ty­ing up with Cana­da’s largest fed­er­al re­search and de­vel­op­ment or­ga­ni­za­tion, Na­tion­al Re­search Coun­cil of Cana­da (NRC), to take the coro­n­avirus pro­gram for­ward.

VBI has been work­ing with the NRC for more than a decade. In fact, the cell line that un­der­pins the VLP tech­nol­o­gy was orig­i­nal­ly in-li­censed from the NRC, CEO Jeff Bax­ter told End­points News.

Jeff Bax­ter

Re­cent­ly, the NRC con­fi­den­tial­ly dis­closed to VBI that it had a specif­i­cal­ly de­signed anti­gen for Covid-19. “And so through a pe­ri­od of dis­cus­sion in the last sev­er­al weeks, we came to the col­lab­o­ra­tion that we’re an­nounc­ing to­day,” he said.

The VBI vac­cine can­di­date is ex­pect­ed to be test­ed in an­i­mals in the next few months, and if all goes well, the plan is to take the in­ves­ti­ga­tion­al vac­cine in­to hu­man tri­als by the end of the year.

On Mon­day, J&J dis­closed it had cho­sen a Covid-19 vac­cine can­di­date, which it ex­pects to take in­to the clin­ic by Sep­tem­ber. “We would like­ly be a cou­ple of months af­ter that,” Bax­ter said.

THE GLOB­AL VAC­CINE HUNT

Typ­i­cal­ly, it takes about a decade or more to de­sign and de­vel­op vac­cines and the process is cost­ly with a high rate of tri­al at­tri­tion. As the coro­n­avirus pan­dem­ic sweeps across the globe dis­rupt­ing every as­pect of hu­man life and leav­ing gov­ern­ments and pub­lic health agen­cies in its wake, a pla­toon of bio­phar­ma com­pa­nies have an­swered the clar­i­on call to de­vel­op a vac­cine quick­ly. The short­est fea­si­ble pe­ri­od a vac­cine can be safe­ly de­vel­oped un­der these cir­cum­stances is ex­pect­ed to be about 12 to 18 months.

Mul­ti­ple vac­cine tech­nolo­gies are in the mix. In an ar­ti­cle in the New Eng­land Jour­nal of Med­i­cine pub­lished on Mon­day, re­searchers from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tion (CEPI) — an or­ga­ni­za­tion that is con­tribut­ing to the glob­al vac­cine hunt — put to­geth­er a list of the var­i­ous ef­forts:

Source: NE­JM, 2020

Click on the im­age to see the full-sized ver­sion

“In the mR­NA ap­proach or the DNA ap­proach, what is hap­pen­ing is that the nu­cle­ic acid vac­cine — RNA or DNA — is man­u­fac­tured in the lab, and then in­ject­ed di­rect­ly. And what one would ex­pect is the ex­pres­sion of pro­teins, and then the stim­u­la­tion of the im­mune sys­tem,” Di­az-Mit­o­ma said. “In our case, it’s a more di­rect ap­proach — a more clas­si­cal ap­proach — where we’re build­ing a par­ti­cle al­so in the lab, in cell cul­ture. And then, these par­ti­cles al­ready have the pro­tein that will stim­u­late the im­mune sys­tem. So, our process doesn’t re­quire the ex­tra step of RNA or DNA. It’s a pro­tein that stim­u­lates and in­ter­acts with the im­mune sys­tem right away.”

Be­yond de­vel­op­ing an ef­fi­ca­cious vac­cine, a com­pa­ny’s abil­i­ty to man­u­fac­ture the vac­cine quick­ly is al­so para­mount. NI­AID di­rec­tor An­tho­ny Fau­ci has stressed that the best strat­e­gy from a vac­cine per­spec­tive is for mak­ers to shore up man­u­fac­tur­ing even be­fore they have con­crete ev­i­dence of ef­fi­ca­cy so that vac­cines can be de­ployed quick­ly if they are proven to be safe and ef­fec­tive.

Yes­ter­day, J&J an­nounced a $1 bil­lion deal with the US gov­ern­ment to cre­ate enough man­u­fac­tur­ing ca­pac­i­ty to make more than 1 bil­lion dos­es of a vac­cine.

As VBI is us­ing tech­nol­o­gy that has al­ready been val­i­dat­ed in oth­er on­go­ing tri­als, the com­pa­ny al­ready has part­ner­ships in place with CROs that have the req­ui­site man­u­fac­tur­ing ap­pa­ra­tus to make the coro­n­avirus vac­cine. In the com­ing months, if proof-of-con­cept da­ta is promis­ing, that ca­pac­i­ty can be aug­ment­ed, not on­ly in North Amer­i­ca but al­so in Eu­rope and coun­tries such as Chi­na and Sin­ga­pore, Bax­ter sug­gest­ed.

This plat­form is “kind of a proven tech­nol­o­gy” with a rea­son­ably straight­for­ward man­u­fac­tur­ing process, while the mR­NA vac­cines or the DNA vac­cines will re­quire be­spoke man­u­fac­tur­ing fa­cil­i­ties, which have a high de­gree of com­put­er­i­za­tion and au­toma­tion. “So we kind of have that ad­van­tage,” he said, “and I think the in­ter­est­ing thing will be…whether or not, in fact, they can scale up quick enough.”

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