Covid-19 Track­er up­dates vac­cine can­di­dates

By Jeff Craven

On March 11, the World Health Or­ga­ni­za­tion clas­si­fied the Covid-19 out­break as a pan­dem­ic. The dis­ease has reached near­ly every coun­try, in­fect­ing hun­dreds of thou­sands of peo­ple and killing thou­sands.

Cur­rent­ly, there are no FDA-ap­proved ther­a­pies or vac­cines for SARS-CoV-2, the virus that caus­es Covid-19. The Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) with­in the Na­tion­al In­sti­tutes of Health (NIH) is lead­ing the fund­ing of fed­er­al re­search and re­sponse to Covid-19, while some com­pa­nies in the US are choos­ing to fund their own Covid-19 re­search. In­ter­na­tion­al­ly, the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) and Eu­ro­pean Med­i­cines Agency (EMA) have called for tar­get­ed ef­forts to de­vel­op ther­a­pies against Covid-19.

Ex­perts es­ti­mate it could take be­tween 12-18 months to de­vel­op a vac­cine ready for mar­ket, which as­sumes the process from con­cep­tion to mar­ket avail­abil­i­ty goes smooth­ly. This track­er lists the ma­jor vac­cine can­di­dates in de­vel­op­ment for pre­ven­tion of Covid-19.

This track­er will be up­dat­ed week­ly. If you no­tice an is­sue with this da­ta or wish to sub­mit an up­date, please email Fo­cus at news@raps.org.

UP­DAT­ED 8 April 2020 to re­flect tri­als of BCG vac­cine in health­care per­son­nel, ini­ti­a­tion of a Phase 1 tri­al and sev­er­al new pre­clin­i­cal can­di­dates.

Phase 2/3 vac­cine can­di­date

Or­ga­ni­za­tions: Uni­ver­si­ty of Mel­bourne and Mur­doch Chil­dren’s Re­search In­sti­tute (Aus­tralia); Rad­boud Uni­ver­si­ty Med­ical Cen­ter (The Nether­lands); Faust­man Lab at Mass­a­chu­setts Gen­er­al Hos­pi­tal (MGH) (Unit­ed States)

Vac­cine can­di­date: Bacil­lus Cal­mette-Guerin (BCG) live-at­ten­u­at­ed vac­cine for COVID-19

Orig­i­nal in­di­ca­tion: Tu­ber­cu­lo­sis (TB) pe­di­atric vac­cine

De­tails: The BCG vac­cine has been im­pli­cat­ed in help­ing to com­bat oth­er in­fec­tions out­side TB by boost­ing the im­mune sys­tem to fight sim­i­lar in­fec­tions. In 2017, the World Health Or­ga­ni­za­tion (WHO) re­port­ed the BCG vac­cine may be ef­fec­tive against lep­rosy and oth­er non­tu­ber­cu­lous my­cobac­te­ria such as bu­ruli ul­cer dis­ease. Oth­er pa­pers have posit­ed the vac­cine is ef­fec­tive in pre­vent­ing acute res­pi­ra­to­ry tract in­fec­tions in el­der­ly pa­tients, oth­er res­pi­ra­to­ry in­fec­tion and sep­sis. A re­cent non-peer re­viewed pa­per in the preprint serv­er medRx­iv has sug­gest­ed coun­tries with BCG vac­ci­na­tion pro­grams at child­hood are far­ing bet­ter in the fight against COVID-19 com­pared with coun­tries that do not re­quire BCG vac­ci­na­tion.

Sta­tus: The ran­dom­ized, con­trolled, Phase 3 BRACE tri­al in Aus­tralia is cur­rent­ly re­cruit­ing and aims to re­cruit 4,170 health­care work­ers in hos­pi­tals in Aus­tralia (NCT04327206). Re­searchers in The Nether­lands launched the ran­dom­ized, par­al­lel-as­sign­ment, phase 3 BCG-CORO­NA tri­al on March 31 and plan to en­roll 1,500 health­care work­ers to re­ceive the BCG vac­cine or place­bo (NCT04328441). The Faust­man Lab is cur­rent­ly eval­u­at­ing the BCG vac­cine’s ef­fec­tive­ness in type 1 di­a­betes and is seek­ing fund­ing to launch tri­al to as­sess whether the vac­cine helps pre­vent COVID-19 in health­care work­ers, ac­cord­ing to in­de­pen­dent re­port­ing from the New York Times.

Phase 1 vac­cine can­di­dates

Com­pa­ny: Mod­er­na

Vac­cine can­di­date: mR­NA-1273

De­tails: Mod­er­na is the Mass­a­chu­setts-based biotech com­pa­ny be­hind mR­NA-1273, a vac­cine can­di­date de­vel­oped us­ing pri­or stud­ies of re­lat­ed coro­n­avirus­es, such as se­vere acute res­pi­ra­to­ry syn­drome (SARS) and Mid­dle East res­pi­ra­to­ry syn­drome (MERS).

Study De­sign: A Phase 1, open-la­bel, dose-rang­ing clin­i­cal tri­al of 45 healthy par­tic­i­pants be­tween 18-55 years old

In­sti­tu­tion: Kaiser Per­ma­nente Wash­ing­ton Health Re­search In­sti­tute

Sta­tus: Re­cruit­ing was com­plet­ed on 19 March 2020

Clin­i­cal­Tri­als.gov Iden­ti­fi­er: NCT04283461

Fund­ing: NI­AID

Com­pa­ny: CanSi­no Bi­o­log­ics

Vac­cine can­di­date: Ad5-nCoV

De­tails: Chi­na’s CanSi­no Bi­o­log­ics has de­vel­oped a re­com­bi­nant nov­el coro­n­avirus vac­cine that in­cor­po­rates the ade­n­ovirus type 5 vec­tor (Ad5).

Study De­sign: A Phase 1 clin­i­cal tri­al of 108 par­tic­i­pants be­tween 18 and 60 years old who will re­ceive low, medi­um, and high dos­es of Ad5-nCoV

In­sti­tu­tion: Tongji Hos­pi­tal; Wuhan, Chi­na

Sta­tus: Cur­rent­ly re­cruit­ing

Chi­nese Clin­i­cal Tri­al Reg­istry Iden­ti­fi­er: ChiC­TR2000030906

Or­ga­ni­za­tion: The Uni­ver­si­ty of Ox­ford

Vac­cine can­di­date: ChA­dOx1

De­tails: The Ox­ford Vac­cine Group at the Uni­ver­si­ty of Ox­ford have iden­ti­fied a new vac­cine can­di­date for Covid-19, a chim­panzee ade­n­ovirus vac­cine vec­tor called ChA­dOx1. The team has pre­vi­ous­ly de­vel­oped a MERS vac­cine.

Sta­tus: Re­cruit­ment is un­der­way of up to 510 healthy adult vol­un­teers aged 18-55 years to be en­rolled in a Phase 1 clin­i­cal tri­al, ac­cord­ing to the uni­ver­si­ty. More in­for­ma­tion on the tri­al is avail­able here.

Com­pa­ny: In­ovio Phar­ma­ceu­ti­cals

Vac­cine can­di­date: INO-4800

De­tails: In­ovio is de­vel­op­ing a DNA vac­cine for SARS-CoV-2 that is in line with oth­er DNA vac­cines the com­pa­ny is de­vel­op­ing, such as for the MERS coro­n­avirus. The vac­cine is in­ject­ed in­tra­der­mal­ly through a de­vice which In­ovio plans to scale pro­duc­tion of while they wait for re­sults of INO-4800.

Study de­sign: A non-ran­dom­ized, open la­bel tri­al of 40 healthy vol­un­teers who will re­ceive one or two in­tra­der­mal in­jec­tions (1.0 mg) of INO-4800 at base­line and at 4 weeks, fol­lowed by elec­tro­po­ra­tion.

Sta­tus: On 6 April, In­ovio an­nounced the start of their Phase 1 clin­i­cal tri­al (NCT04336410) at sites in Philadel­phia and Kansas City.

Pre-clin­i­cal vac­cine can­di­dates

Com­pa­nies: Pfiz­er and BioN­Tech

Vac­cine can­di­date: BNT162

De­tails: Pfiz­er and BioN­tech have an­nounced an agree­ment to col­lab­o­rate on de­vel­op­ing an mR­NA-based Covid-19 vac­cine orig­i­nal­ly de­vel­oped by BioN­Tech. The com­pa­nies had pre­vi­ous­ly agreed to de­vel­op an mR­NA-based in­fluen­za vac­cine in 2018.

Sta­tus: Clin­i­cal test­ing is ex­pect­ed to be­gin in April 2020

Or­ga­ni­za­tion: Uni­ver­si­ty of Pitts­burgh’s Cen­ter for Vac­cine Re­search

Vac­cine can­di­date: PittCo­V­acc

De­tails: Re­searchers at the Uni­ver­si­ty of Pitts­burgh have re­ceived a $4.9 mil­lion grant from CEPI to de­vel­op a Covid-19 vac­cine can­di­date.

Sta­tus: On April 2, Uni­ver­si­ty of Pitts­burgh School of Med­i­cine sci­en­tists an­nounced they had de­vel­oped a can­di­date Covid-19 vac­cine that is ef­fec­tive in mice, de­liv­ered through a fin­ger­tip patch. Ac­cord­ing to a pa­per pub­lished in EBio­Med­i­cine, the vac­cine cre­ates an­ti­bod­ies in mice that the re­searchers be­lieve is suf­fi­cient to neu­tral­ize the virus.

Com­pa­ny: No­vavax

Vac­cine can­di­date: No name an­nounced

De­tails: Biotech com­pa­ny No­vavax an­nounced in March that it has pro­duced sev­er­al re­com­bi­nant nanopar­ti­cle vac­cine can­di­dates for Covid-19 and is vet­ting them in an­i­mal test­ing.

Sta­tus: No­ravax hopes to be­gin clin­i­cal test­ing in late spring of 2020. The com­pa­ny not­ed they are see­ing pos­i­tive re­sults af­ter a few weeks of test­ing, ac­cord­ing to orig­i­nal re­port­ing from a CBS af­fil­i­ate.

Com­pa­ny: Cure­Vac

Vac­cine can­di­date: No name an­nounced

De­tails: Cure­Vac an­nounced they are de­vel­op­ing an mR­NA-based Covid-19 vac­cine “with­in a few months,” ac­cord­ing to a press re­lease. Sta­tus: The com­pa­ny plans to start clin­i­cal tri­als in the sum­mer and have iden­ti­fied two study cen­ters.

Com­pa­ny: Generex Biotech­nol­o­gy

Vac­cine can­di­date: Ii-Key pep­tide Covid-19 vac­cine

De­tails: Biotech com­pa­ny Generex sub­sidiary Nu­Generex Im­muno-On­col­o­gy is spear­head­ing a vac­cine project to cre­ate an Ii-Key pep­tide vac­cine against Covid-19.

Sta­tus: In a com­pa­ny press re­lease dat­ed 27 Feb­ru­ary, Generex said they want­ed to pro­duce a vac­cine can­di­date that could be test­ed in hu­mans “with­in 90 days.”

Com­pa­ny: Vaxart

Vac­cine can­di­date: Oral re­com­bi­nant Covid-19 vac­cine

De­tails: Vaxart an­nounced their agree­ment with Emer­gent Bioso­lu­tions to de­vel­op and man­u­fac­ture their oral re­com­bi­nant vac­cine can­di­date for Covid-19.

Sta­tus: The com­pa­ny plans to ini­ti­ate a Phase 1 clin­i­cal study “ear­ly in the sec­ond half of 2020,” ac­cord­ing to a press re­lease.

Com­pa­ny: Im­pe­r­i­al Col­lege Lon­don

Vac­cine can­di­date: Self-am­pli­fy­ing RNA vac­cine

De­tails: Im­pe­r­i­al Col­lege Lon­don re­searchers are de­vel­op­ing a self-am­pli­fy­ing RNA vac­cine for Covid-19. They de­vel­oped a vac­cine can­di­date with­in 14 days of re­ceiv­ing the se­quence from Chi­na.

Sta­tus: An­i­mal test­ing is un­der­way; the re­searchers aim to be­gin clin­i­cal tri­als in the sum­mer of 2020.

Com­pa­ny: Med­ica­go

Vac­cine can­di­date: Plant-based Covid-19 vac­cine

De­tails: Med­ica­go, which re­cent­ly de­vel­oped a sea­son­al re­com­bi­nant quadri­va­lent virus-like par­ti­cle (VLP) in­fluen­za vac­cine, re­port­ed they cre­at­ed a coro­n­avirus VLP 20 days af­ter work­ing with the SARS-CoV-2s gene.

Sta­tus: The com­pa­ny says their vac­cine is in the pre-clin­i­cal test­ing stage, and they ex­pect to be­gin hu­man test­ing in Ju­ly or Au­gust of 2020.

Com­pa­ny: Takis Biotech

Vac­cine can­di­date: DNA-based vac­cine for Covid-19

De­tails: The part­ner­ship be­tween Takis Biotech and Ap­plied DNA Sci­ences has re­sult­ed in four DNA vac­cine can­di­dates for Covid-19.

Sta­tus: Takis ex­pects pre­clin­i­cal test­ing re­sults in April 2020; their fi­nal vac­cine can­di­date could be­gin hu­man test­ing by fall, ac­cord­ing to a com­pa­ny press re­lease.

Com­pa­nies: John­son & John­son and BAR­DA

Vac­cine can­di­date: No name an­nounced

De­tails: John­son & John­son has an­nounced their in­ten­tion to de­vel­op a Covid-19 vac­cine, us­ing their Ad­Vac and PER.C6 sys­tems, which were al­so used to de­vel­op the com­pa­ny’s Ebo­la vac­cine.

Sta­tus: J&J says they plan to have a vac­cine can­di­date by the end of March, with hu­man tri­als start­ing in No­vem­ber 2020.

Com­pa­ny: Al­tim­mune

Vac­cine can­di­date: In­tranasal Covid-19 vac­cine

De­tails: Al­tim­mune has de­vel­oped a Covid-19 vac­cine can­di­date us­ing the same tech­nol­o­gy they used build their in­fluen­za vac­cine, Naso­VAX. The Covid-19 vac­cine would be de­liv­ered in­tranasal­ly in a sin­gle dose.

Sta­tus: Ac­cord­ing to a com­pa­ny press re­lease, an­i­mal test­ing is be­gin­ning, and clin­i­cal test­ing is slat­ed for Au­gust 2020 or lat­er.

Re­search in ad­di­tion­al vac­cine can­di­dates

Com­pa­nies: Glax­o­SmithK­lineClover Bio­phar­ma­ceu­ti­cals and Xi­a­men In­no­vax

Vac­cine can­di­date: Covid-19 S-Trimer

De­tails: GSK has en­tered in­to a col­lab­o­ra­tion agree­ment with Chi­nese com­pa­ny Clover Phar­ma­ceu­ti­cals to use its ad­ju­vant tech­nol­o­gy for Clover’s Covid-19 can­di­date S-Trimer. GSK al­so has part­nered with Chi­nese com­pa­ny Xi­a­men In­no­vax Biotech and of­fered its vac­cine ad­ju­vant tech­nol­o­gy to the com­pa­ny.

Sta­tus: In a press re­lease, GSK says its S-Trimer can­di­date is be­ing “rapid­ly de­vel­oped,” and pre-clin­i­cal stud­ies are be­ing planned.

Com­pa­ny: BIO­CAD

Vac­cine can­di­date: mR­NA vac­cine can­di­date

De­tails: Russ­ian biotech com­pa­ny BIO­CAD an­nounced it is de­vel­op­ing an mR­NA vac­cine can­di­date for Covid-19.

Sta­tus: BIO­CAD said it ex­pects to be­gin an­i­mal test­ing in April 2020.

Com­pa­ny: Heat Bi­o­log­ics

Vac­cine can­di­date: gp96-based vac­cine

De­tails: The biotech com­pa­ny Heat Bi­o­log­ics an­nounced it is pair­ing with the Uni­ver­si­ty of Mi­a­mi to use the gp96 heat shock pro­tein back­bone to de­vel­op at least one Covid-19 vac­cine.

In­sti­tu­tion: Uni­ver­si­ty of Mi­a­mi Miller School of Med­i­cine

Sta­tus: Added to WHO’s draft land­scape of Covid-19 vac­cines

Com­pa­nies: CSL and The Uni­ver­si­ty of Queens­land

Vac­cine can­di­date: Mol­e­c­u­lar clamp vac­cine for Covid-19

De­tails: Re­searchers at the Uni­ver­si­ty of Queens­land have achieved a proof-of-con­cept vac­cine can­di­date for Covid-19.

In­sti­tu­tion: The Uni­ver­si­ty of Queens­land

Sta­tus: In a press re­lease, the uni­ver­si­ty said they will be­gin fur­ther de­vel­op­ment pri­or to pre-clin­i­cal test­ing.

Com­pa­ny: Sanofi and Trans­late Bio

Vac­cine can­di­date: Re­pur­posed SARS vac­cine and mR­NA vac­cine can­di­date

De­tails: Sanofi an­nounced in Feb­ru­ary that is was de­vel­op­ing a Covid-19 vac­cine can­di­date un­der its egg-free, re­com­bi­nant DNA plat­form us­ing work from a pre­vi­ous SARS vac­cine and in part­ner­ship with the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA). Sanofi al­so an­nounced in late March that they were part­ner­ing with Trans­late Bio to cre­ate an mR­NA vac­cine can­di­date for Covid-19.

Sta­tus: The com­pa­ny hopes to have a vac­cine can­di­date for lab test­ing with­in 6 months, ac­cord­ing to orig­i­nal re­port­ing from STAT.

Com­pa­ny: Ex­preS2ion Biotech­nolo­gies

Vac­cine can­di­date: No name an­nounced

De­tails: Den­mark-based Ex­preS2ion won a Eu­ro­pean Union (EU) Hori­zon 2020 grant to fund a Covid-19 vac­cine can­di­date.

Sta­tus: The com­pa­ny said they plan to per­form a Phase 1/2a clin­i­cal tri­al and aim to be­gin clin­i­cal test­ing with­in 12 months.

Com­pa­ny: Uni­ver­si­ty of Saskatchewan Vac­cine and In­fec­tious Dis­ease Or­ga­ni­za­tion-In­ter­na­tion­al Vac­cine Cen­tre

Vac­cine can­di­date: No name an­nounced

De­tails: The Uni­ver­si­ty of Saskatchewan’s Vac­cine and In­fec­tious Dis­ease Or­ga­ni­za­tion-In­ter­na­tion­al Vac­cine Cen­tre (VI­DO-In­ter­Vac) is de­vel­op­ing a vac­cine for Covid-19, re­cent­ly re­ceived $1 mil­lion to ac­cel­er­ate Covid-19 vac­cine can­di­date test­ing.

Sta­tus: Pre­clin­i­cal.

Com­pa­ny: Epi­Vax

Vac­cine can­di­date: Ii-Key pep­tide vac­cine

De­tails: Epi­Vax is de­vel­op­ing two Ii-Key pep­tide vac­cine can­di­dates against Covid-19.

Sta­tus: Epi­Vax’s CEO said a vac­cine could be ready with­in 5-6 months if the com­pa­ny re­ceives the right lev­el of fund­ing.

Com­pa­ny: Coda­genix

Vac­cine can­di­date: Live at­ten­u­at­ed Covid-19 vac­cine

De­tails: Coda­genix an­nounced in Feb­ru­ary that it had used the nCoV genome to map out sev­er­al vac­cine can­di­date genomes for Covid-19.

Sta­tus: The com­pa­ny said the next step is to grow and test the vac­cine virus­es in vi­vo be­fore ini­ti­at­ing clin­i­cal tri­als, but gave no time­line for when test­ing would be­gin.

Com­pa­ny: Zy­dus Cadi­la

Vac­cine can­di­date: DNA and/or live at­ten­u­at­ed re­com­bi­nant Covid-19 vac­cine can­di­date

De­tails: In­dia’s Zy­dus Cadi­la an­nounced in Feb­ru­ary they are re­search­ing two vac­cine can­di­dates for Covid-19. The first would use a DNA vac­cine tar­get­ing the vi­ral en­try mem­brane pro­tein of the virus, while the sec­ond us­es a live at­ten­u­at­ed re­com­bi­nant measles virus tar­get­ed to Covid-19.

Sta­tus: No de­tails have been re­leased at this time.

Com­pa­ny: Sino­vac

Vac­cine can­di­date: For­ma­lin-in­ac­ti­vat­ed and alum-ad­ju­vant­ed can­di­date vac­cine for Covid-19

De­tails: Sino­vac is pur­port­ed­ly work­ing on a for­ma­lin-in­ac­ti­vat­ed and alum-ad­ju­vant­ed can­di­date vac­cine for Covid-19, ac­cord­ing to the WHO draft land­scape of Covid-19 vac­cines.

Sta­tus: No de­tails have been re­leased at this time.

Com­pa­ny: Geo­vax and Bravo­vax

Vac­cine can­di­date:

De­tails: In Jan­u­ary, Chi­nese biotech com­pa­nies Geo­vax and Bravo­vax an­nounced they would col­lab­o­rate to cre­ate a mod­i­fied vac­cinia ankara virus like par­ti­cles (MVA-VLP) vac­cine can­di­date for Covid-19.

Sta­tus: Geo­vax said it’s cur­rent­ly in the process of nar­row­ing their vac­cine can­di­dates down from three to one, and from there will move to test­ing in hu­mans.

Com­pa­ny: Gr­ef­fex

Vac­cine can­di­date: Ade­n­ovirus-based vec­tor vac­cine for Covid-19

De­tails: Ge­net­ic en­gi­neer­ing com­pa­ny Gr­ef­fex is de­vel­op­ing an ade­n­ovirus-based vec­tor vac­cine for Covid-19.

Sta­tus: The com­pa­ny re­cent­ly an­nounced its vac­cine can­di­date has en­tered the an­i­mal test­ing stage.

Com­pa­ny: Wal­ter Reed Army In­sti­tute of Re­search and Unit­ed States Army Med­ical Re­search In­sti­tute of In­fec­tious Dis­eases

Vac­cine can­di­date: No name an­nounced

De­tails: Wal­ter Reed, to­geth­er with the U.S. Army Med­ical Re­search In­sti­tute of In­fec­tious Dis­eases, is work­ing on a Covid-19 vac­cine. Re­searchers at Wal­ter Reed had pre­vi­ous­ly de­vel­oped a MERS vac­cine, and is us­ing that work to help them cre­ate a vac­cine can­di­date for Covid-19.

Sta­tus: Wal­ter Reed has de­vel­oped sev­er­al vac­cine can­di­dates, and have be­gun test­ing in an­i­mals, but have not yet in­di­cat­ed when they would be­gin clin­i­cal test­ing in hu­mans.

Or­ga­ni­za­tion: MI­GAL Galilee Re­search In­sti­tute

Vac­cine can­di­date: Mod­i­fied avian coro­n­avirus vac­cine

Details: The in­sti­tute said it plans to cre­ate a new Covid-19 vac­cine can­di­date by adapt­ing its re­search in de­vel­op­ing a vac­cine for the ge­net­i­cal­ly-sim­i­lar avian coro­n­avirus In­fec­tious Bron­chi­tis Virus (IBV).

Sta­tus: On 27 Feb­ru­ary, the in­sti­tute said it planned to cre­ate the vac­cine with­in the next 8-10 weeks, will seek safe­ty ap­proval with­in 90 days, and is in dis­cus­sion with part­ners for hu­man tri­als

Com­pa­ny: AJ­Vac­cines

Vac­cine can­di­date: No name an­nounced

De­tails: In March, Dan­ish-based vac­cine man­u­fac­tur­er AJ­Vac­cines said they would use mod­ern anti­gen tech­nol­o­gy to de­vel­op a Covid-19 vac­cine can­di­date that would have a “high pro­tec­tion with a low re­ac­to­genic­i­ty and fa­vor­able safe­ty pro­file.”

Sta­tus: The com­pa­ny has not giv­en a time­line for fur­ther de­vel­op­ment or test­ing.

Or­ga­ni­za­tion: Bay­lor Col­lege of Med­i­cine

Vac­cine can­di­date: Re-pur­posed SARS vac­cine for Covid-19; S1 or RBD pro­tein vac­cine can­di­date

De­tails: Re­searchers at the Bay­lor Col­lege of Med­i­cine say they have a shelved vac­cine from the 2003 SARS out­break that could be re­pur­posed for use in the Covid-19 pan­dem­ic. They are al­so de­vel­op­ing an S1 or RBD pro­tein vac­cine as a tar­get­ed vac­cine can­di­date for Covid-19.

Sta­tus: The uni­ver­si­ty has not re­leased de­tails on de­vel­op­ing or test­ing at this time.

Or­ga­ni­za­tion: In­sti­tut Pas­teur

Vac­cine can­di­date: No name an­nounced

De­tails: In­sti­tut Pas­teur is part­ner­ing with the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) to de­vel­op a Covid-19 vac­cine can­di­date.

Sta­tus: No oth­er de­tails have been re­leased at this time.

Com­pa­ny: Tonix Phar­ma­ceu­ti­cals and South­ern Re­search

Vac­cine can­di­date: Horse­pox vac­cine with per­cu­ta­neous ad­min­is­tra­tion

De­tails: Bio­phar­ma­ceu­ti­cals com­pa­ny Tonix is part­ner­ing with South­ern Re­search to de­vel­op a Covid-19 vac­cine can­di­date based on the com­pa­ny’s horse­pox vac­cine, TNX-1800, is work­ing

Sta­tus: Tonix hasn’t of­fered a time­line for fur­ther de­vel­op­ment or test­ing.

Or­ga­ni­za­tions: Fu­dan Uni­ver­si­ty, Shang­hai Jiao­Tong Uni­ver­si­ty, and RNACure Bio­phar­ma

Vac­cine can­di­date: mR­NA vac­cine can­di­date for Covid-19

De­tails: Fu­dan Uni­ver­si­ty has en­tered in­to a part­ner­ship with Shang­hai JiaoTang Uni­ver­si­ty, and RNACure to de­vel­op a Covid-19 mR­NA vac­cine can­di­date. They are us­ing two meth­ods to de­vel­op an mR­NA-based vac­cine: us­ing mR­NA to ex­press the re­cep­tor-bind­ing do­main of the spike pro­tein of Covid-19 to in­duce neu­tral­iz­ing-an­ti­bod­ies, and de­vel­op­ing mR­NAs that can in­struct the host to pro­duce virus-like par­ti­cles sim­i­lar to SARS-CoV-2.

Sta­tus: No de­tails on fur­ther de­vel­op­ment or test­ing are avail­able at this time.

Com­pa­ny: Arc­turus Ther­a­peu­tics and Duke-NUS Med­ical School

Vac­cine can­di­date: No name an­nounced

De­tails: Arc­turus and Duke are part­ner­ing to de­vel­op a Covid-19 vac­cine can­di­date that us­es Arc­turus’ self-repli­cat­ing RNA and nanopar­ti­cle non-vi­ral de­liv­ery sys­tem.

Sta­tus: The com­pa­nies have not re­leased fur­ther de­tails about de­vel­op­ment or test­ing.

Or­ga­ni­za­tion: Pe­ter Do­her­ty In­sti­tute for In­fec­tion and Im­mu­ni­ty

Vac­cine can­di­date: No name an­nounced

De­tails: The Do­her­ty In­sti­tute has re­ceived $3.2 mil­lion from the Jack Ma foun­da­tion to ac­cel­er­ate the cre­ation of a Covid-19 vac­cine with an ac­tive and pas­sive plat­form.

Sta­tus: No oth­er de­tails have been re­leased at this time.

Or­ga­ni­za­tion: Tu­lane Uni­ver­si­ty

Vac­cine can­di­date: The Tu­lane Na­tion­al Pri­mate Re­search Cen­ter has launched a Covid-19 re­search pro­gram to help de­vel­op a vac­cine can­di­date.

Sta­tus: The or­ga­ni­za­tion has not es­tab­lished a time­line for test­ing, but has in­di­cat­ed it will use a pri­mate mod­el for an­i­mal test­ing.

Com­pa­ny: Sor­ren­to Ther­a­peu­tics, Inc. and Smart­Pharm Ther­a­peu­tics Inc.

Vac­cine can­di­date: Gene-en­cod­ed an­ti­body vac­cine can­di­date

De­tails: In late March, Sor­ren­to Ther­a­peu­tics an­nounced a col­lab­o­ra­tion with Smart­Pharm Ther­a­peu­tics to de­vel­op a next-gen­er­a­tion, gene-en­cod­ed an­ti­body vac­cine for Covid-19. Sta­tus: In a press re­lease, Smart­Pharm Ther­a­peu­tics said it hopes to have a can­di­date with­in sev­er­al months.

Or­ga­ni­za­tion: Uni­ver­si­ty of Bris­tol (Imophoron)

Vac­cine can­di­date: No name an­nounced

De­tails: On 7 April, Imophoron, a spin-out com­pa­ny from the Uni­ver­si­ty of Bris­tol’s Bris­Syn­Bio re­search cen­ter, has an­nounced it is pro­duc­ing sev­er­al vac­cine can­di­dates for Covid-19 us­ing its AD­Domer plat­form.

Sta­tus: Vac­cine de­vel­op­ment is in a pre-clin­i­cal stage, ac­cord­ing to a press re­lease from the uni­ver­si­ty.

Com­pa­ny: IMV

Vac­cine can­di­date: DPX-Covid-19

De­tails: IMV, a biotech com­pa­ny based in Cana­da, an­nounced its in­tent to cre­ate a vac­cine can­di­date for Covid-19 based off DPX-Sur­vivac, a T-cell ac­ti­vat­ing im­munother­a­py anti­gen vac­cine cur­rent­ly be­ing test­ed in tri­als for ef­fec­tive­ness against re­cur­rent ovar­i­an can­cer, ad­vanced and re­cur­rent sol­id tu­mors, and sur­vivin-ex­press­ing dif­fuse large B-cell lym­phoma DL­B­CL.

Sta­tus: The com­pa­ny is de­vel­op­ing a phase 1 clin­i­cal study of 48 healthy sub­jects and plans to be­gin the tri­al in the sum­mer of 2020, ac­cord­ing to a press re­lease.

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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