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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.