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, Clin­i­cal­tri­als.gov 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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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