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.

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.

George Golumbeski (L) and Faheem Hasnain

George Golumbes­ki and Fa­heem Has­nain team up with Ver­tex Ven­tures HC in man­ag­ing $320M of biotech cash

Two longtime biotech veterans are joining a multibillion dollar VC firm in order to help steer its latest fund.

George Golumbeski and Faheem Hasnain have signed on to Vertex Ventures HC as executive advisors, the company announced Thursday, and will assist with their depth of experience in managing $320 million of capital. Both have had previous working relationships with managing partners Carolyn Ng and Lori Hu, which evolved “organically” to get to this point, Ng said.

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Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A p-val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a p-value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Covid-19 roundup: Boehringer pulls a drug out of the pipeline for a PhII Covid-19 tri­al; No­vavax de­lays PhI­II tri­al in US, with PhII da­ta com­ing Fri­day

With big questions still hanging over the fate of the vaccines and drugs now in late-stage development for Covid-19, Boehringer Ingelheim is pulling one of its early-stage drugs into a Phase II trial to see if it can help some of the most severely afflicted patients.

Put through a safety study last year, researchers have been intrigued by the potential of BI 764198 — a TRPC6 inhibitor — as a treatment for acute respiratory distress syndrome (ARDS), which can cause immense damage and death for patients exposed to the virus.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.