Covid-19 roundup: EU‘s top sci­en­tist re­signs in re­buke to agency’s Covid re­sponse; J&J posts neg­a­tive da­ta for its HIV drug

As the nov­el coro­n­avirus took root around the globe in ear­ly March, the Eu­ro­pean Union’s top sci­en­tist pro­posed launch­ing a pro­gram that would fund the world’s top re­searchers work­ing on new drugs, vac­cines, di­ag­nos­tic tools and oth­er tools in the Covid-19 re­sponse.

But to­day, Mau­ro Fer­rari, the Ital­ian-Amer­i­can who leads the Eu­ro­pean Re­search Coun­cil, is re­sign­ing. He told the Fi­nan­cial Times that he was met with unan­i­mous op­po­si­tion from the ERC’s gov­ern­ing Sci­en­tif­ic Coun­cil, who said they were on­ly al­lowed to fund “bot­tom-up” re­search pro­posed by sci­en­tists and not give “top-down” dic­tates that re­flect­ed EU pri­or­i­ties.

“I have been ex­treme­ly dis­ap­point­ed by the Eu­ro­pean re­sponse to Covid-19,” he said in a state­ment pro­vid­ed to and pub­lished by FT, cit­ing fail­ures to co­or­di­nate on bor­ders, health poli­cies, or tar­get­ed sci­en­tif­ic re­ser­ar­ch.

“I thought that at times like these, the very best should pick up their best weapons, and go to the fron­tier, to the front-lines, to de­feat this for­mi­da­ble en­e­my,” he added. “I ar­gued that this was not the time for sci­en­tif­ic gov­er­nance to wor­ry ex­ces­sive­ly about the sub­tleties of the dis­tinc­tions be­tween Bot­tom-Up ver­sus Top-Down re­search.”

Fer­rari, an ear­ly pi­o­neer of nanomed­i­cine, took his post in Jan­u­ary. He said he de­vel­oped a plan with Eu­ro­pean Com­mis­sion pres­i­dent Ur­su­la von der Leyen af­ter she asked him about pan­dem­ic re­sponse, but “the very fact that I worked di­rect­ly with her cre­at­ed an in­ter­nal po­lit­i­cal thun­der­storm.”

Fer­rari, who re­tains a teach­ing post at the Uni­ver­si­ty of Wash­ing­ton, said he stepped down to launch an in­ter­na­tion­al Covid-19 re­sponse ini­tia­tive. ”I am afraid that I have seen enough of both the gov­er­nance of sci­ence, and the po­lit­i­cal op­er­a­tions at the Eu­ro­pean Union,” he said. “Now it is time for me to re­turn to the fron­tier, to the front­lines of the fight against Covid-19, with re­al re­sources and re­spon­si­bil­i­ties, away from of­fices in Brus­sels, where my po­lit­i­cal skills are clear­ly in­ad­e­quate, and again at the true ser­vice of those who need new med­ical so­lu­tions.” — Ja­son Mast

J&J re­searchers: Our HIV an­tivi­ral doesn’t work against Covid-19

A J&J HIV an­tivi­ral now be­ing used in a cou­ple of tri­als against Covid-19 has no ef­fect against the nov­el coro­n­avirus, re­searchers for the com­pa­ny found.

In a preprint post­ed to­day, the re­searchers said that darunavir, a drug that in­hibits HIV pro­teas­es, showed “no ac­tiv­i­ty” against SARS–CoV-2. That was in con­trast to remde­sivir, the Gilead drug that’s been giv­en to thou­sands of Covid-19 pa­tients and for which clin­i­cal da­ta are ex­pect­ed soon. Used as a pos­i­tive con­trol, remde­sivir showed “po­tent an­tivi­ral ac­tiv­i­ty.”

“Over­all the da­ta do not sup­port the use of DRV for treat­ment of Covid-19,” they wrote.

Des­per­ate for ap­proved drugs that might be ef­fec­tive against a new virus, Doc­tors turned to HIV drugs ear­ly in the cri­sis, al­though there’s lim­it­ed ev­i­dence that they have since proven ef­fec­tive. A tri­al pub­lished in the New Eng­land Jour­nal of Med­i­cine showed two such drugs — a com­bi­na­tion of lopinavir and ri­ton­avir that Ab­b­Vie mar­kets as Ke­la­tra — of­fered “no ben­e­fit” to pa­tients, al­though crit­ics not­ed that the pa­tients in the study may have been giv­en the drugs too late for them to be ef­fec­tive.

J&J warned ear­ly on that darunavir was un­like­ly to work, and some vi­rol­o­gists have ar­gued that, in com­par­i­son to a broad-spec­trum drug like remde­sivir, HIV pro­tease in­hibitors are too spe­cial­ized to HIV to be ef­fec­tive for such a dif­fer­ent type of virus. Still, Clin­i­cal­tri­ lists three stud­ies — one in Chi­na, one in Thai­land, and one in Spain — that are us­ing darunavir as part of their pro­to­col.

Remde­sivir’s suc­cess in vit­ro — in test tubes — had al­ready been es­tab­lished. Hu­man da­ta on the drug is ex­pect­ed as ear­ly as this week. — Ja­son Mast

As­traZeneca joins Covid-19 drug hunt with an­ti­body dis­cov­ery pact

Two days af­ter Glax­o­SmithK­line re­served a $250 mil­lion front row seat in the search for an­ti­bod­ies that can neu­tral­ize the virus caus­ing Covid-19, Big Phar­ma brethren As­traZeneca has un­veiled its own dis­cov­ery ef­fort.

The UK drug­mak­er may be join­ing the game al­most a month lat­er than Eli Lil­ly — which en­list­ed Cana­di­an an­ti­body shop Ab­Cellera for its ef­fort — but it’s in­tent on mov­ing fast. The aim is to be ready for clin­i­cal eval­u­a­tion in the next 3 to 5 months.

More than 50 of its staffers — with ex­per­tise in vi­rol­o­gy, pro­tein en­gi­neer­ing, clin­i­cal and bio­process — have been as­signed to the in-house dis­cov­ery work, lever­ag­ing a tech­nol­o­gy de­vel­oped in a pact with the US De­fense Ad­vanced Re­search Pro­jects Agency. They will scour sev­er­al sources, from pa­tients who have re­cov­ered from Covid-19 to hu­man­ized mice to lab tech­niques such as phage dis­play, in pur­suit of the most promis­ing can­di­dates.

Col­lab­o­ra­tions with gov­ern­ment and aca­d­e­m­ic ex­perts will add to its fire­pow­er. The Chi­nese Acad­e­my of Sci­ences and Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter, for in­stance, are pro­vid­ing ge­net­ic se­quences for an­ti­bod­ies they have iden­ti­fied to be as­sessed by As­traZeneca. Mean­while, the Unit­ed States Army Med­ical Re­search In­sti­tute of In­fec­tious Dis­eases and the Uni­ver­si­ty of Mary­land School of Med­i­cine will help with the pre­clin­i­cal safe­ty and ef­fi­ca­cy tests.

It marks As­traZeneca’s first ma­jor ini­tia­tive to de­vel­op po­ten­tial treat­ments for the coro­n­avirus in­fec­tions rav­aging the world, fol­low­ing face mask do­na­tions and a col­lab­o­ra­tion with GSK to boost test­ing ca­pac­i­ty in the UK.

An­ti­body-based treat­ments have been de­scribed as a bridge be­tween vac­cines and ther­a­peu­tics as they have the po­ten­tial to both pre­vent and treat Covid-19. Re­gen­eron and GSK-part­nered Vir were among the ear­li­est and most promi­nent in the space, though small­er play­ers such as Brii Bio and I-Mab are al­so pitch­ing in. — Am­ber Tong

A fourth vac­cine tech­nol­o­gy may go in­to the clin­ic in a month

Fol­low­ing the mR­NA, DNA and ade­n­ovirus-based vac­cine can­di­dates against SARS-CoV-2, No­vavax said it’s locked in a re­com­bi­nant nanopar­ti­cle vac­cine to push in­to hu­man tri­als by mid-May.

It’s the same tech­nol­o­gy be­hind the flu vac­cine, NanoFlu, that pro­duced en­cour­ag­ing im­muno­genic­i­ty da­ta in a Phase III tri­al read out re­cent­ly. In that study, NanoFlu ap­peared non-in­fe­ri­or to Sanofi’s best-sell­ing Flu­zone.

The cur­rent time­line for its Covid-19 pro­gram — dubbed NVX-CoV2373 — is weeks ahead of sched­ule, said CEO Stan­ley Er­ck. Pre­lim­i­nary re­sults on whether it is safe and gen­er­ates neu­tral­iz­ing an­ti­bod­ies are ex­pect­ed in Ju­ly. By then, Ger­many’s BioN­Tech and Cure­Vac are ex­pect­ed to have en­tered the clin­ic with their mR­NA vac­cine con­structs as well.

An­i­mal stud­ies sug­gest that No­vavax’s vac­cine did in­duce the pro­duc­tion of spike pro­tein-spe­cif­ic an­ti­bod­ies, which would the­o­ret­i­cal­ly block the virus from en­ter­ing the cell by de­fend­ing the ACE2 hu­man re­cep­tor bind­ing do­main.

Place­bo-con­trolled and blind­ed, their Phase I will re­cruit around 130 healthy adult vol­un­teers.

Emer­gent BioSo­lu­tions is man­u­fac­tur­ing the vac­cine for clin­i­cal tri­als. CEPI, the Oslo-based coali­tion that’s backed a swath of drug­mak­ers pur­su­ing a coro­n­avirus vac­cine, gave No­vavax $4 mil­lion back in March. — Am­ber Tong

Glob­al tri­al en­roll­ment sees dras­tic drop

As the pan­dem­ic sweeps around the world, forc­ing bio­phar­ma com­pa­nies to mod­i­fy their R&D plans, a new re­port has cap­tured just how dra­mat­i­cal­ly clin­i­cal tri­als are be­ing dis­rupt­ed. The av­er­age num­ber of new pa­tients en­ter­ing tri­als per study site around the world de­creased 65% year-over-year in March, the clin­i­cal tri­al ser­vice firm Me­di­da­ta found. Break it down by ge­o­graph­ic re­gions, and you see the UK (80%) and In­dia (84%) hit hard­est, fol­lowed by the US (67%), France (68%) and Spain (68%).

The two coun­tries that im­proved be­tween Feb­ru­ary and March were Ar­genti­na and Chi­na. In Chi­na, we saw a 68% de­crease in new pa­tients en­ter­ing tri­als YoY dur­ing March, but the sil­ver lin­ing was that March was 240% high­er than Feb­ru­ary in terms of new pa­tients added, which could be a lead­ing in­di­ca­tor of Chi­na re­turn­ing to nor­mal­cy.

A num­ber of com­pa­nies, in­clud­ing some of the biggest play­ers, have hit pause on tri­als to a vary­ing de­gree, the re­port not­ed. But for any re­main­ing ac­tiv­i­ty, a shift to vir­tu­al­iza­tion — or to low­er-im­pact­ed re­gions — will be key. — Am­ber Tong

Funds, equip­ment and now for some free med­i­cine 

As the coro­n­avirus pan­dem­ic robs peo­ple of their jobs, crea­ture com­forts and free­dom to meet friends and fam­i­ly in the Unit­ed States, it of­ten means in­di­vid­u­als al­so lose ac­cess to health in­sur­ance, which is of­ten linked to em­ploy­ment.

While its Big Phar­ma com­pa­tri­ots have of­fered up fi­nan­cial sup­port, equip­ment and al­lowed their cer­ti­fied per­son­nel to vol­un­teer their ser­vices to com­bat the out­break, Bris­tol My­ers Squibb is tak­ing things one step fur­ther. In an ex­pan­sion to its ex­ist­ing pa­tient sup­port pro­grams, the com­pa­ny said it would pro­vide its med­i­cines for free el­i­gi­ble un­em­ployed US pa­tients who have lost their health in­sur­ance due to the Covid-19 pan­dem­ic.

“At this time, we have not ex­pe­ri­enced any dis­rup­tion in our clin­i­cal or com­mer­cial sup­ply chain due to the pan­dem­ic,” chief Gio­van­ni Caforio said in a state­ment.

Among oth­er ef­forts, the com­pa­ny has al­so iden­ti­fied ap­prox­i­mate­ly 1,000 com­pounds in its dis­cov­ery li­brary that it is mak­ing avail­able to col­lab­o­ra­tors, such as the Bill and Melin­da Gates Foun­da­tion, for screen­ing for po­ten­tial treat­ments for Covid-19, it said, adding that it is al­so eval­u­at­ing cer­tain med­i­cines in its port­fo­lio that could be in­clud­ed in near-term clin­i­cal tri­als. — Na­tal­ie Grover

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

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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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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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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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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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 14. 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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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

NIH director Francis Collins at a Senate Appropriations subcommittee hearing for Operation Warp Speed (Graeme Jennings/Pool via AP Images)

Covid-19 roundup: As­traZeneca signs 400M vac­cine sup­ply deal with EU; Sinopharm re­ports pos­i­tive Phase I/II da­ta for vac­cine can­di­date

Amid talks with multiple players, the European Commission has reached its first vaccine supply deal with AstraZeneca, securing 400 million doses of the Oxford candidate for all of its member countries.

The pharma giant said in a press release that the deal builds on the existing agreement with Germany, France, Italy and the Netherlands, announced in June. It was unclear, however, whether that means simply extending the same 400 million doses to all EU countries or doubling the reservation to 800 million doses.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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