Covid-19 roundup: Mod­er­na show­cas­es progress on its bi­va­lent boost­er; No­vavax wins ap­proval in Japan

New da­ta from Mod­er­na of­fer en­cour­ag­ing re­sults for the mR­NA pow­er­house’s bi­va­lent boost­er can­di­date.

The bi­va­lent boost­er can­di­date, known as mR­NA-1273.211 and which in­cludes mu­ta­tions found in the Be­ta vari­ant of con­cern, best­ed the com­pa­ny’s orig­i­nal boost­er in terms of neu­tral­iz­ing titers against all vari­ants of con­cern, in­clud­ing Omi­cron.

The news, which fol­lows sim­i­lar re­sults for the Pfiz­er/BioN­Tech Covid-19 vac­cine when com­bined with Be­ta, bodes well for the boost­er in the fall.

“We be­lieve that these re­sults val­i­date our bi­va­lent strat­e­gy, which we an­nounced and be­gan pur­su­ing in Feb­ru­ary 2021. The re­sults in­di­cate that mR­NA-1273.211 at the 50-µg dose lev­el in­duced high­er an­ti­body re­spons­es than the 50-µg mR­NA-1273 boost­er, even when ad­di­tion­al vari­ants of con­cern were not in­clud­ed in the boost­er vac­cine,” Stéphane Ban­cel, CEO of Mod­er­na, said in a state­ment. “Our lat­est bi­va­lent boost­er can­di­date, mR­NA-1273.214, which com­bines the cur­rent­ly au­tho­rized Mod­er­na COVID-19 boost­er with our Omi­cron-spe­cif­ic boost­er can­di­date, re­mains our lead can­di­date for the fall 2022 North­ern Hemi­sphere boost­er. We look for­ward to shar­ing ini­tial da­ta on mR­NA-1273.214 lat­er in the sec­ond quar­ter.”

The com­pa­ny on Tues­day re­vealed a 2.2-fold (95% CI: 1.74, 2.79) and 2.15-fold (95% CI: 1.66, 2.78) in­crease in the neu­tral­iz­ing an­ti­body titers against Omi­cron with the mR­NA-1273.211 boost­er dose com­pared to the Spike­vax boost­er dose at one month and six months, re­spec­tive­ly, among 895 par­tic­i­pants in the study.

Nu­vax­ovid Covid-19 vac­cine and boost­er re­ceive ap­proval in Japan

No­vavax has now seen its Covid-19 vac­cine au­tho­rized in just about every coun­try ex­cept for the US, as Japan on Tues­day be­came the lat­est to OK the shot.

No­vavax and its part­ner Take­da re­ceived man­u­fac­tur­ing and mar­ket­ing ap­proval from the Japan Min­istry of Health, La­bor and Wel­fare for the in­jec­tion, which is now ap­proved for pri­ma­ry and boost­er im­mu­niza­tion in in­di­vid­u­als aged 18 and old­er with dis­tri­b­u­tion start­ing as soon as pos­si­ble.

The vac­cine, known as Nu­vax­ovid, is the first pro­tein-based vac­cine to be au­tho­rized for use in Japan.

“To­geth­er with Take­da, we are pleased to be able to of­fer the first pro­tein-based COVID-19 vac­cine to adults aged 18 and over in Japan,” said Stan­ley Er­ck, pres­i­dent and CEO of No­vavax. “This ap­proval is sig­nif­i­cant be­cause it in­cludes both pri­ma­ry and boost­er vac­ci­na­tion.”

The ap­proval is based on Take­da’s NDA sub­mis­sion which in­clud­ed pos­i­tive in­ter­im re­sults from a Phase I/II study con­duct­ed by Take­da in Japan and sev­er­al stud­ies con­duct­ed by No­vavax, in­clud­ing two piv­otal Phase III clin­i­cal tri­als in the UK, US and Mex­i­co as well as Phase I/II stud­ies in Aus­tralia and the US. Ad­di­tion­al safe­ty and ef­fi­ca­cy da­ta were sub­mit­ted for boost­er im­mu­niza­tion re­view, which in­clud­ed a Phase II study con­duct­ed by No­vavax in South Africa for a sin­gle vac­ci­na­tion giv­en six months af­ter pri­ma­ry im­mu­niza­tion.

Ac­cord­ing to No­vavax, Take­da will man­u­fac­ture the vac­cine at its Hikari-based fa­cil­i­ty. Take­da and the Japan­ese gov­ern­ment have agreed to make and sup­ply about 400 mil­lion dos­es of the No­vavax shot.

Mask en­force­ment to be­come more re­laxed as fed­er­al judge drops man­date

Fed­er­al of­fi­cials will no longer en­force a mask man­date af­ter a fed­er­al judge struck down the re­quire­ment to wear a mask on bus­es, trains and air­planes as well as in trans­porta­tion hubs in­clud­ing air­ports.

US Dis­trict Judge Kathryn Kim­ball Mizelle of Flori­da said the man­date ex­ceeds the statu­to­ry au­thor­i­ty of the CDC. The case was brought on be­half of a con­ser­v­a­tive le­gal group known as Health Free­dom De­fense Fund and as well as sev­er­al air­line pas­sen­gers.

The judge ruled in fa­vor of the plain­tiffs on sev­er­al key is­sues, find­ing that the CDC had ex­ceed­ed its le­gal au­thor­i­ty, and the man­date’s fail­ure to pro­vide no­tice and com­ment was not a harm­less er­ror.

A new team at the CDC plans to pro­vide bet­ter and faster in­fo on Covid-19

A new team of fed­er­al health sci­en­tists at the CDC will pro­vide bet­ter, faster in­for­ma­tion about what is like­ly to hap­pen next in this pub­lic health emer­gency and fu­ture in­fec­tious dis­ease out­breaks.

Ac­cord­ing to the Wash­ing­ton Post, around 100 sci­en­tists will be a part of this team, an­a­lyz­ing tech­ni­cal da­ta and pol­i­cy op­tions for de­ci­sion-mak­ers and the pub­lic about how the virus is be­hav­ing and who is most at risk but us­ing user-friend­ly terms.

To be known as the Cen­ter for Fore­cast­ing and Out­break An­a­lyt­ics, which starts with $200 mil­lion in fund­ing, the cen­ter was cre­at­ed in 2021 to im­prove the un­der­stand­ing of the CDC and the gov­ern­ment more broad­ly of Covid-19 and any fu­ture out­breaks in re­al-time.

This ef­fort will al­so act as a boon to get ahead of any po­ten­tial fu­ture pan­demics as there is no na­tion­al sys­tem for in­fec­tious dis­ease fore­cast­ing. The cen­ter will al­so pro­vide sup­port and analy­ses to de­ci­sion-mak­ers at both the fed­er­al lev­el and to states. This in­cludes fore­cast­ing how many Covid cas­es might be ex­pect­ed in the com­ing days and weeks by an­a­lyz­ing the num­ber of new cas­es and hos­pi­tal­iza­tions as well as ex­am­in­ing the pop­u­la­tions most af­fect­ed.

The cen­ter will al­so an­a­lyze the spread of in­fec­tions, vac­cine pro­tec­tion against se­vere ill­ness, the im­pact of vari­ants on vac­cines and the time since vac­ci­na­tion.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Al Sandrock, Voyager Therapeutics CEO

Al San­drock prunes his post-Bio­gen voy­age with sim­i­lar fo­cus on ALS

Al Sandrock is narrowing the focus of Voyager Therapeutics, concentrating on CNS diseases that were the hallmark of his time leading R&D at Biogen, including an emphasis on a familial form of ALS for which his former employer is getting a speedy review at the FDA.

Less than six months into his journey as CEO at Voyager, Sandrock is focusing the preclinical pipeline on Alzheimer’s disease, GBA1 Parkinson’s disease and SOD1 amyotrophic lateral sclerosis, the rare form of ALS for which the FDA will decide whether to approve Biogen’s tofersen by Jan. 25, 2023.

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Pfiz­er ter­mi­nates PhI­II study of rare car­dio­vas­cu­lar drug picked up in $11.4B Ar­ray ac­qui­si­tion

While Pfizer’s $11.4 billion acquisition of Array BioPharma in the summer of 2019 was mainly focused on oncology, namely Braftovi and Mektovi, there were a few non-cancer assets, including a Phase III drug being tested in a rare cardiovascular disease.

The late-stage trial is now being axed, alongside any further development of the oral small molecule, the pharma giant disclosed after the closing bell on Wednesday. Based on an interim futility analysis of the global Phase III REALM-DCM trial, Pfizer determined a path forward was not in its best interest. Pfizer no longer expected the study would meet its primary goal.

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