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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

Despite Ugur Sahin’s calls for calm over the Omicron variant — making a much more measured appeal than Moderna CEO Stéphane Bancel — the BioNTech chief is already predicting the potential need for new Covid-19 vaccines.

In comments made at a conference hosted Friday morning by Reuters, Sahin said that even though vaccinated individuals would likely still be protected from severe disease, Omicron could see greater numbers of breakthrough infections than other variants. The mutations mean Covid shots will probably become necessary every year, similar to the flu.