Covid-19 roundup: Re­gen­eron scores $2.6B US sup­ply deal for an­ti­body cock­tail; Brazil­ian re­searchers walk back ef­fi­ca­cy rate for Sino­vac's can­di­date

The US is con­tin­u­ing to buy up every dose of an­ti­body cock­tail that Re­gen­eron can pro­duce, sign­ing off on a $2.625 bil­lion deal to fol­low $450 mil­lion of in­vest­ments made in Ju­ly.

Whether Re­gen­eron can de­liv­er the best-case sce­nario — 1.25 mil­lion dos­es by the end of June — de­pends in large part on the FDA’s stance on the 1,200mg dose. The pair of an­ti­bod­ies, casiriv­imab and imde­vimab, is cur­rent­ly au­tho­rized on­ly at the 2,400mg dose lev­el (1,200mg each). Right now, the big biotech is in the process of de­liv­er­ing dos­es to treat 300,000 peo­ple fol­low­ing the emer­gency use au­tho­riza­tion in No­vem­ber.

So if reg­u­la­tors don’t ex­pand the EUA to cov­er the low­er-dose reg­i­men — still un­der clin­i­cal test­ing for the same pop­u­la­tion, non-hos­pi­tal­ized, mild to mod­er­ate Covid-19 pa­tients at high risk of pro­gres­sion — soon, Re­gen­eron will on­ly be able to sup­ply around 750,000 fin­ished dos­es.

In a piv­otal out­pa­tient tri­al, on­ly the high­er dose helped pa­tients achieve sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in virus lev­els and re­quire few­er med­ical vis­its. But com­pa­ny ex­ecs em­pha­sized the da­ta on seroneg­a­tive pa­tients, not­ing that those who are most at risk ben­e­fit­ed the most from their drug, even at low dos­es.

“Ad­di­tion­al­ly, as ex­pect­ed, the virus con­tin­ues to mu­tate, with the pos­si­bil­i­ty of de­vel­op­ing re­sis­tance to any one an­ti­body,” pres­i­dent and CSO George Yan­copou­los said in a state­ment. “The Re­gen­eron cock­tail of two an­ti­bod­ies, each tar­get­ing a dif­fer­ent site on the virus, re­duces the pos­si­bil­i­ty of the virus be­com­ing re­sis­tant.”

The De­part­ment of Health and Hu­man Ser­vices and the De­part­ment of De­fense are pur­chas­ing the an­ti­bod­ies from Re­gen­eron and plan to of­fer them to Amer­i­cans at no cost, though hos­pi­tals may charge for ad­min­is­tra­tion. To date, the HHS Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse says it has al­lo­cat­ed more than 127,700 treat­ment cours­es.

“With COVID-19 cas­es con­tin­u­ing to rise, treat­ing peo­ple with mild or mod­er­ate in­fec­tions can help pre­vent hos­pi­tal­iza­tions, which will re­duce the bur­den on health­care sys­tems,” said Robert Kadlec, HHS As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse.

Out­side the US, Re­gen­eron has teamed up with Roche to de­vel­op, man­u­fac­ture and dis­trib­ute casiriv­imab and imde­vimab glob­al­ly. The goal is to have more than 2 mil­lion treat­ment dos­es avail­able an­nu­al­ly.

Brazil­ian re­searchers walk back ef­fi­ca­cy rate for Sino­vac’s can­di­date

Less than a week af­ter tout­ing a 78% ef­fi­ca­cy rate for Sino­vac’s Covid-19 can­di­date, Brazil’s Bu­tan­tan In­sti­tute is walk­ing back that claim. Sci­en­tists are now say­ing the vac­cine is on­ly 50.4% ef­fec­tive at pre­vent­ing symp­to­matic in­fec­tions — just high enough to meet reg­u­la­to­ry stan­dards, Reuters re­port­ed.

Why the stark dif­fer­ence? Re­searchers said par­tial re­sults showed a 78% ef­fi­ca­cy rate against “mild-to-se­vere” cas­es, leav­ing out an­oth­er group of “very mild” cas­es en­tire­ly, ac­cord­ing to Reuters.

Tri­al sites around the world have re­port­ed vary­ing ef­fi­ca­cy rates for the Chi­nese vac­cine, dubbed Coro­n­aVac. Re­searchers in Turkey said the can­di­date was 91.25% ef­fec­tive based on an in­ter­im analy­sis. And sci­en­tists in In­done­sia said in­ter­im da­ta showed a 65% ef­fi­ca­cy rate.

The 50.4% fig­ure is much low­er than the ef­fi­ca­cy rates of Pfiz­er/BioN­Tech and Mod­er­na’s can­di­dates, which are 95% and 94.5% ef­fec­tive at pre­vent­ing symp­to­matic cas­es, re­spec­tive­ly.

The news comes weeks af­ter un­named sources in­volved in the Brazil­ian tri­als told the Wall Street Jour­nal that Sino­vac’s can­di­date was at least 50% ef­fec­tive.

Brazil­ian pres­i­dent Jair Bol­sonaro is a known skep­tic of the Chi­nese vac­cine. How­ev­er, a state gov­er­nor said last month that Brazil would buy 46 mil­lion dos­es, Reuters re­port­ed.

Coro­n­aVac us­es in­ac­ti­vat­ed virus to trig­ger an im­mune re­sponse. It was au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment back in Ju­ly. And in June, Sino­vac signed a deal with In­sti­tu­to Bu­tan­tan to ad­vance clin­i­cal tri­als to Phase III.

Brazil briefly put the tri­al on hold in No­vem­ber, fol­low­ing the death of a par­tic­i­pant. It re­sumed short­ly af­ter, and the state gov­ern­ment re­vealed that the vol­un­teer had died by sui­cide.

In ear­ly De­cem­ber, Sino­vac struck a deal with Chi­na’s Sino Bio­phar­ma­ceu­ti­cal for $515 mil­lion to dou­ble pro­duc­tion ca­pac­i­ty. In re­turn, Sino Bio­phar­ma­ceu­ti­cal will get a 15.03% in­ter­est in Sino­vac Life Sci­ences. At the time, Sino­vac said it would be able to pump out up to 600 mil­lion dos­es an­nu­al­ly with an added pro­duc­tion fa­cil­i­ty. — Nicole De­Feud­is

Synair­gen dos­es first pa­tient with re­pur­posed in­ter­fer­on be­ta-1a treat­ment

Synair­gen has dosed the first pa­tient in a Phase III tri­al to see if its COPD and asth­ma can­di­date works against Covid-19.

In a small Phase II tri­al, Synair­gen says hos­pi­tal­ized Covid-19 pa­tients who took its in­hal­able in­ter­fer­on be­ta-1a for­mu­la­tion, SNG001, were twice as like­ly to re­cov­er with­in 14 days than pa­tients on a place­bo. Parex­el Biotech is now help­ing con­duct the Phase III tri­al which has al­ready ini­ti­at­ed sev­er­al UK sites, with more in the US and the EU ex­pect­ed to fol­low. The study will take place across 20 coun­tries, en­rolling a to­tal of 610 Covid-19 pa­tients who re­quire sup­ple­men­tal oxy­gen.

“We need treat­ments as well as vac­cines to fight high­ly path­o­gen­ic virus­es such as SARS-CoV-2,” CEO Richard Mars­den said in a state­ment. “De­vel­op­ment of treat­ments like ours will re­main nec­es­sary in cas­es where vac­cines are not ef­fec­tive, for those who do not get vac­ci­nat­ed, and in case the virus mu­tates to the point where vac­cines be­come less ef­fec­tive.”

Mars­den told End­points News in No­vem­ber that what in­ter­est­ed the biotech most dur­ing Phase II was time to full re­cov­ery. For the pur­pos­es of the study, Synair­gen de­fined “full re­cov­ery” as the point where a pa­tient no longer ex­pe­ri­ences lim­i­ta­tions in every­day ac­tiv­i­ties. By that mea­sure, 21 pa­tients (44%) in the treat­ment arm reached full re­cov­ery over the 14-day treat­ment course, ver­sus 11 (22%) in the place­bo group.

“The thing that we’re most ex­cit­ed about is get­ting peo­ple back to this lev­el of no lim­i­ta­tion of ac­tiv­i­ties, and you’re more than twice as like­ly — ap­proach­ing three times as like­ly in some of the analy­ses — of get­ting back to that lev­el if you’re on drug com­pared to place­bo,” Mars­den said in No­vem­ber.

Af­ter pri­ma­ry and sec­ondary end­point re­sults are re­port­ed, par­tic­i­pants in Phase III will con­tin­ue to be as­sessed for long-term Covid-19 symp­toms. — Nicole De­Feud­is

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.