Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be de­layed from its orig­i­nal ear­ly Ju­ly goal, but Mod­er­na says it will still kick off the piv­otal study for what could ul­ti­mate­ly be the first Covid-19 vac­cine be­fore the end of the month.

A day af­ter Reuters re­port­ed that squab­bling be­tween the Cam­bridge biotech and gov­ern­ment reg­u­la­tors had held up the tri­al by about two weeks, Mod­er­na re­leased a state­ment say­ing that they had com­plet­ed en­roll­ment of their 650-per­son Phase II tri­al and were on track to be­gin Phase III by the end of the month. The pro­to­col for that study, which is meant to prove whether or not the vac­cine can pre­vent peo­ple from be­com­ing sick, has been fi­nal­ized, they said.

Al­though Mod­er­na did not con­firm the two-week set­back to Reuters, the com­pa­ny ac­knowl­edged it had de­layed de­liv­er­ing the tri­al pro­to­col to reg­u­la­tors and claimed that it de­cid­ed to de­lay the launch. Ac­cord­ing to the sources cit­ed by Reuters, the com­pa­ny dif­fered with reg­u­la­tors and oth­er ex­perts on the lev­el of pa­tient mon­i­tor­ing need­ed and what the bar for ef­fi­ca­cy should be.

The 30,000-per­son Phase III tri­al will be the first of sev­er­al con­duct­ed with gov­ern­ment as­sis­tance to test whether a Covid-19 vac­cine is ef­fec­tive. As­traZeneca is al­so ex­pect­ed to start their own large study this sum­mer, with J&J fol­low­ing there­after.

Mod­er­na said they have al­ready made enough dos­es of the vac­cine for their Phase III and are on track to ex­pand ca­pac­i­ty enough to make 500 mil­lion to 1 bil­lion dos­es per year start­ing in 2021. — Ja­son Mast

Eu­rope se­cures Actem­ra, MS drug as fight over treat­ment ac­cess heats up

An in­ter­na­tion­al fight to se­cure first ac­cess to ex­per­i­men­tal Covid-19 vac­cines has been brew­ing for months. Now, a sim­i­lar tug-of-war is un­fold­ing over treat­ments.

The US has been the most ag­gres­sive, re­ceiv­ing the first ma­jor sup­ply of remde­sivir through do­na­tions and then buy­ing up the en­tire­ty of Gilead’s pro­duc­tion for Ju­ly, and 90% for Au­gust and Sep­tem­ber. Yes­ter­day, they al­so snared the first 70,000 to 300,000 treat­ment dos­es of Re­gen­eron’s ex­per­i­men­tal an­ti­body treat­ment.

Now Eu­rope is try­ing to do the same with the drug de­vel­op­ers in its bor­ders, even if those treat­ments re­main un­proven. The Eu­ro­pean Com­mis­sion has inked deals with Roche for its IL-6 an­ti­body Actem­ra and Mer­ck KGaA for its in­ter­fer­on-be­ta an­ti­body, mak­ing them avail­able for how­ev­er many dos­es a mem­ber coun­try wants to buy, a source told Reuters Wednes­day.

The drugs are meant to tamp down the hy­per­ac­tive im­mune re­sponse that caus­es some of Covid-19’s worst symp­toms, but they are far from proven. Actem­ra failed to help pa­tients with ear­ly-stage pneu­mo­nia last month, though some ret­ro­spec­tive analy­ses sug­gest it could be of use in lat­er-stages. Rebif, a mul­ti­ple-scle­ro­sis drug, is be­ing test­ed in sev­er­al stud­ies for its Covid-19 ef­fects. — Ja­son Mast

CEPI gives third ma­jor grant in ex­change for ac­cess to dos­es of vac­cine

The Coali­tion for Epi­dem­ic Pre­pared­ness has hand­ed out its third largest round of fund­ing yet for a Covid-19 vac­cine ef­fort, pour­ing $66 mil­lion in­to the Chi­nese biotech Clover Bio­phar­ma­ceu­ti­cals and their pro­tein-based vac­cine.

The new fund­ing will help push Clover’s vac­cine through the Phase I tri­al it be­gan last month in Aus­tralia while al­so help­ing it scale up man­u­fac­tur­ing and pre­pare for a larg­er study to test whether it can ac­tu­al­ly pre­vent Covid-19. It’s the sec­ond round of fund­ing CEPI has pro­vid­ed to Clover. They al­so made a $3.5 mil­lion in­vest­ment in April.

Like CEPI’s oth­er re­cent large grants, the new fund­ing calls for Clover to pro­vide dos­es of its vac­cine to Co­v­ax, the pro­gram CEPI, WHO, and Gavi, the Vac­cine Al­liance set up to help eq­ui­tably dis­trib­ute vac­cines around the globe. Nei­ther CEPI nor Clover said how many dos­es the com­pa­ny would pro­vide, but in June, CEPI gave As­traZeneca near­ly $400 mil­lion in a deal that pro­vid­ed for 300 mil­lion dos­es. No­vavax al­so agreed to pro­vide dos­es in ex­change for a near­ly $400 mil­lion but did not spec­i­fy how many.

Clover’s pro­gram is one of sev­er­al vac­cine can­di­dates that use Glax­o­SmithK­line’s ad­ju­vant tech­nol­o­gy to boost im­mune re­spons­es. — Ja­son Mast

EU backs Os­i­vax’s pur­suit of a uni­ver­sal vac­cine

The race to find a vac­cine for the nov­el coro­n­avirus con­tin­ues to heat up, as the Eu­ro­pean Com­mis­sion’s pi­lot R&D arm taps French biotech Os­i­vax to head up its unique ap­proach to the re­search.

Aim­ing to de­vel­op a uni­ver­sal jab for the flu and Covid-19, Os­i­vax se­cured around $20 mil­lion in “blend­ed fi­nanc­ing” from the Eu­ro­pean In­no­va­tion Coun­cil. About $3 mil­lion comes from a Covid-19 “ac­cel­er­a­tor grant” and will go to­ward com­plet­ing Os­i­vax’s sig­na­ture flu vac­cine, dubbed OVX836 and cur­rent­ly in Phase IIa. The rest will be in­clud­ed as part of Os­i­vax’s Se­ries B fund­ing, which aims to launch the Phase IIb por­tion of the study.

Alexan­dre Le Vert

“Sim­i­lar to in­fluen­za, which leads to reg­u­lar glob­al out­breaks, Covid-19 has the po­ten­tial to mu­tate,” Os­i­vax CEO Alexan­dre Le Vert said in a state­ment. “The abil­i­ty to pro­tect peo­ple from the cur­rent and fu­ture coro­n­avirus strains is a tremen­dous op­por­tu­ni­ty for us and we are par­tic­u­lar­ly thank­ful for this fund­ing and the val­i­da­tion that it pro­vides our sci­ence and tech­nol­o­gy mov­ing for­ward.”

Os­i­vax was one of on­ly 28 ap­pli­cants out of 1,400 to re­ceive an ac­cel­er­a­tor grant.

Crit­ics of the Eu­ro­pean Com­mis­sion — which in­clude Sanofi CEO Paul Hud­son — say they have dragged their feet in fund­ing Covid-19 re­search, at least com­pared to the re­sponse of the US gov­ern­ment. A “Eu­ro­pean Strat­e­gy,” un­veiled June 17, out­lined the method­ol­o­gy the EU would choose to se­lect vac­cine can­di­dates, and an­nounced more than $11 bil­lion in funds raised from mem­ber coun­tries to com­mit to vac­cine re­search.

The French biotech sets it­self apart as a T cell vac­cine. By fo­cus­ing its tech­nol­o­gy on at­tack­ing a flu virus’ nu­cle­o­pro­tein, which, un­like the rest of the virus, is much less like­ly to mu­tate, Os­i­vax hopes to not on­ly in­oc­u­late against cur­rent strains of the flu but al­so against fu­ture vari­ants.

Part of the OVX836 pro­gram will ap­ply this tech­nol­o­gy against SARS-CoV-2, the strain of coro­n­avirus that caus­es Covid-19. Os­i­vax’s Se­ries B fund­ing is ex­pect­ed to fi­nance a way to prove the ef­fi­ca­cy of its vac­cine.

In­vest­ment bank Bpifrance al­so chipped in about $17 mil­lion as part of its pro­gram to fund pri­vate com­pa­nies seek­ing to find a COVID-19 vac­cine. — Max Gel­man

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

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.