Jean-Pierre Sommadossi, Atea CEO

Covid-19 roundup: Atea Phar­ma­ceu­ti­cals launch­es an­tivi­ral in­to PhI­II tri­al; Cell­tri­on's an­ti­body shows promise against vari­ant

About a year af­ter jump­ing in­to the Covid-19 fight with its lead an­tivi­ral, Atea Phar­ma­ceu­ti­cals has launched a Phase III tri­al in mild to mod­er­ate pa­tients who are not hos­pi­tal­ized.

The drug (and com­pa­ny) come from Jean-Pierre Som­ma­dos­si, the founder of Idenix and a co-founder of Phar­mas­set. The com­pa­ny de­cid­ed to di­vert all their at­ten­tion to Covid-19 last Feb­ru­ary, then pulled in $215 mil­lion to launch a cross-coun­try Phase II tri­al in May.

“Hope­ful­ly we will not have a sec­ond wave,” Som­ma­dos­si told End­points News at the time. “But if we have a sec­ond wave, we need to be ready this time.”

In Oc­to­ber, Roche put down $350 mil­lion up­front plus undis­closed mile­stones and roy­al­ties for ex-US rights to the can­di­date, dubbed AT-527, as an oral an­tivi­ral treat­ment for Covid-19. The ther­a­py works by block­ing the vi­ral RNA poly­merase en­zyme need­ed for vi­ral repli­ca­tion, ac­cord­ing to Roche.

The Phase III MORN­INGSKY tri­al will en­roll 1,400 non-hos­pi­tal­ized pa­tients, in­clud­ing ado­les­cents, who are with­in five days of symp­tom on­set. The study’s pri­ma­ry end­point will eval­u­ate the time to im­prove­ment of symp­toms com­pared to a place­bo. Par­tic­i­pants will come from a va­ri­ety of clin­i­cal tri­al sites world­wide, in­clud­ing in Japan, ac­cord­ing to Atea.

In ad­di­tion to MORN­INGSKY, Roche and Atea are test­ing the can­di­date in a glob­al Phase II for hos­pi­tal­ized pa­tients with mod­er­ate Covid-19, and a Phase II vi­rol­o­gy study in out­pa­tients with mild to mod­er­ate sick­ness.

“As a di­rect-act­ing an­tivi­ral, AT-527 aims to pre­vent dis­ease pro­gres­sion by in­hibit­ing vi­ral repli­ca­tion and there­by re­duc­ing the sever­i­ty of dis­ease, pre­vent­ing or short­en­ing hos­pi­tal­iza­tion, and al­so po­ten­tial­ly pre­vent­ing trans­mis­sion of the virus to oth­ers,”  Som­ma­dos­si said in a state­ment. “This makes it well-suit­ed for po­ten­tial use in both pre- and post-ex­po­sure pro­phy­lac­tic set­tings and com­ple­men­tary to vac­cines.” — Nicole De­Feud­is 

Cell­tri­on’s mAb shows suc­cess against South African vari­ant

Pre-clin­i­cal tri­al re­sults from Cell­tri­on Group’s an­ti-Covid-19 mon­o­clon­al an­ti­body reg­dan­vimab showed neu­tral­iza­tion of the South African vari­ant, the com­pa­ny an­nounced Thurs­day.

Reg­dan­vimab proved ef­fec­tive in an in vi­vo mod­el by bind­ing against the re­cep­tor bind­ing do­main in three mu­ta­tions (K417N, E484K and N501Y) of the vari­ant, Cell­tri­on said in a re­lease. How­ev­er, it al­so showed re­duced sus­cep­ti­bil­i­ty against the South African vari­ant in a live virus and pseu­do-virus in vit­ro study though there was no sig­nif­i­cant dif­fer­ence be­tween the vari­ants and the wild type when ob­serv­ing vi­ral res­pi­ra­to­ry in­fec­tion.

In a state­ment, head of med­ical and mar­ket­ing Ho-Ung Kim said, “Faced with the rapid spread of COVID-19 vari­ants, glob­al ac­cess to ef­fec­tive an­ti­body treat­ment is fun­da­men­tal­ly im­por­tant to re­duce the dis­ease pro­gres­sion rate to se­vere COVID-19 and help out­pa­tients avoid hos­pi­tal­iza­tion and al­le­vi­ate the bur­den on the health care sys­tem. We have com­menced the de­vel­op­ment of a neu­tral­iz­ing an­ti­body cock­tail with CT-P59 against new emerg­ing strains in the UK and South Africa and we will con­tin­ue to fur­ther in­ves­ti­gate the neu­tral­iz­ing an­ti­bod­ies and oth­er re­spons­es to pro­tect against cur­rent SARS-CoV-2 strains and emerg­ing vari­ants.”

In March, the Eu­ro­pean Med­i­cines Agency an­nounced that the mAb could be used as treat­ment for adults who don’t re­quire sup­ple­men­tal oxy­gen and are at high risk of pro­gress­ing to se­vere Covid-19. The EMA said that most side ef­fects re­port­ed were mild or mod­er­ate, but re­sults weren’t ro­bust enough to reach a con­clu­sion on the med­i­cine’s ben­e­fits.

The com­pa­ny be­gan mass pro­duc­ing the mAb in Sep­tem­ber 2020 in hopes of get­ting emer­gency use au­tho­riza­tion. — Josh Sul­li­van

Pfiz­er/BioN­Tech could have vac­cine tri­al re­sults for younger chil­dren by Sep­tem­ber — re­port

BioN­Tech CEO Ugur Sahin says the com­pa­ny could have a look at how its Pfiz­er-part­nered Covid-19 vac­cine works in ba­bies as young as six months old by Sep­tem­ber, ac­cord­ing to Reuters. 

“In Ju­ly, the first re­sults could be avail­able for the five to 12 year olds, in Sep­tem­ber for the younger chil­dren,” he told the Ger­man mag­a­zine Der Spiegel, per Reuters.

Ear­li­er this month, Pfiz­er and BioN­Tech asked the FDA to ex­pand its EUA to in­clude ado­les­cents 12 to 15 years old.

A cou­ple weeks ago, Mod­er­na said its Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US. Mean­while, its Phase II/III Kid­COVE study was still re­cruit­ing chil­dren be­tween 6 months and 11 years old. — Nicole De­Feud­is

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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