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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Katrine Bosley (AP Photo/Mark Lennihan)

For­mer Ed­i­tas CEO Ka­trine Bosley goes the VC route, join­ing ear­ly-stage in­vestor

More than three years after abruptly exiting Editas Medicine, Katrine Bosley is leaping to the venture capital side of things.

London-based early-stage investor Advent Life Sciences announced Thursday that Bosley is joining the firm as venture partner. It’s also adding two general partners to the team: Dominic Schmidt, formerly of Syncona, will be in the UK; and Satish Jindal, most recently the CEO of investment fund BioMotiv, will be based in Boston, just like Bosley.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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