Covid-19 roundup: Tri­al of Trump's fa­vorite Covid-19 drug nixed on ear­ly death risk; Is An­tho­ny Fau­ci on thin ice with the pres­i­dent?

A study in­volv­ing one of Pres­i­dent Trump’s fa­vorite Covid-19 drugs had to be halt­ed ear­ly af­ter re­searchers de­ter­mined that the high dose of the treat­ment was linked to a high­er risk of death.

Brazil­ian re­searchers had planned to en­list 440 pa­tients to test chloro­quine — close­ly con­nect­ed to hy­drox­y­chloro­quine — in in­fect­ed pa­tients. But re­searchers quick­ly spot­ted the safe­ty is­sue. The ab­stract of their pub­lished study con­clud­ed:

The high dose CQ arm pre­sent­ed more QTc>500ms (25%), and a trend to­ward high­er lethal­i­ty (17%) than the low­er dosage.

In­ves­ti­ga­tor Mar­cus Lac­er­da told the New York Times in an email over the week­end that “the high dosage that the Chi­nese were us­ing is very tox­ic and kills more pa­tients.”

The Times al­so re­port­ed that the re­searchers scrapped the study, end­ing test­ing on the low­er dos­ing as well, af­ter de­ter­min­ing they wouldn’t have enough pa­tients to de­ter­mine safe­ty and ef­fi­ca­cy.

Trump has sparked wide­spread crit­i­cism of his re­peat­ed state­ments point­ing to the po­ten­tial of hy­drox­y­chloro­quine and chloro­quine — both used against lu­pus and oth­er au­toim­mune dis­eases in fight­ing the pan­dem­ic as pa­tients and doc­tors grow more des­per­ate to find meds that can work.

“What do you have to lose? I’ll say it again: What do you have to lose? Take it,” he said about hy­drox­y­chloro­quine a few days ago. “I re­al­ly think they should take it.”

Those re­marks in turn have sparked con­sid­er­able push­back from ex­perts who want to see hard da­ta be­fore they start of­fer­ing this drug to a mass num­ber of pa­tients. The Wash­ing­ton Post’s fact-check­ing team of­fered this con­clu­sion to­day:

In par­tic­u­lar, Trump’s in­cor­rect com­ments on the drugs and his role in ad­vo­cat­ing for their use, based on min­i­mal and flim­sy ev­i­dence, sets a bad ex­am­ple. His ad­vo­ca­cy for this un­proven treat­ment pro­vides po­ten­tial­ly false hope and has led to short­ages for peo­ple who re­ly on the drugs. The pres­i­dent earns Four Pinoc­chios.

— John Car­roll

Is An­tho­ny Fau­ci about to be fired?

Over the week­end Pres­i­dent Trump RT’d a Tweet urg­ing the ouster of NI­AID chief An­tho­ny Fau­ci af­ter the coun­try’s top in­fec­tious dis­ease ex­pert said that the pres­i­dent could have done more to put the brakes on the Covid-19 pan­dem­ic and save lives.

Cue a fu­ri­ous on­line tus­sle be­tween fierce sup­port­ers of Fau­ci’s plain spo­ken ad­vo­ca­cy of da­ta and sci­ence over the pres­i­dent’s back­ers, who prize loy­al­ty above all else. The hub­bub has caused “fir­ing Fau­ci” and #Save­Fau­ci to trend on­line.

Fau­ci is al­so ad­vo­cat­ing a cau­tious, go-slow ap­proach to re­open­ing the US econ­o­my, while Trump ap­pears to fa­vor go­ing big and go­ing fast.

— John Car­roll

En­sure hy­drox­y­chloro­quine ac­cess for lu­pus pa­tients, ad­vo­cates ap­peal to Azar, Hahn and Fau­ci

No soon­er had the FDA grant­ed emer­gency au­tho­riza­tion of hy­drox­y­chloro­quine and chloro­quine than it be­gan to note that the two drugs — com­mon­ly used to treat malar­ia and a range of au­toim­mune dis­eases — were in short­age. And now a group of con­cerned lu­pus re­searchers are urg­ing the gov­ern­ment to pro­tect sup­ply of their much need­ed med­ica­tions.

In con­trast to its un­proven util­i­ty against Covid-19, hy­drox­y­chloro­quine “has been proven to mit­i­gate SLE dis­ease ac­tiv­i­ty and to pre­vent flares,” a group of ex­perts con­vened by the Lu­pus Re­search Al­liance not­ed in an open let­ter. “It re­duces joint pain, rash­es, and throm­bot­ic events, and pro­longs sur­vival.”

Led by Gary Ko­ret­zky, chair of the Lu­pus Re­search Al­liance, they urged FDA com­mis­sion­er Stephen Hahn, HHS sec­re­tary Alex Azar and NI­AID di­rec­tor An­tho­ny Fau­ci to en­act mea­sures to en­sure that lu­pus pa­tients would con­tin­ue to have ac­cess to this drug — even as piv­otal tri­als are un­der­way to test whether it can fight coro­n­avirus in­fec­tions. Hy­drox­y­chloro­quine is the most com­mon­ly pre­scribed med for sys­temic lu­pus ery­the­mato­sus.

They added:

If the drug proves to be ef­fi­ca­cious in both con­di­tions, every ef­fort should be made to en­sure that hy­drox­y­chloro­quine is avail­able to every­one whose health re­quires it. Per­haps, now is the time to be­gin plan­ning for that pos­si­bil­i­ty. — Am­ber Tong

‘(T)hey were com­plete­ly obliv­i­ous to the biggest thing that was about to shat­ter their world.’

The Bio­gen out­break has be­come no­to­ri­ous on so­cial me­dia as le­gions of on­line crit­ics point to their an­nu­al strat­e­gy ses­sion at the Mar­riott Long Wharf for pro­mot­ing the spread of coro­n­avirus in the US. Now the New York Times weighs in with its own as­sess­ment of the big biotech’s role in the out­break.

We know that 2 se­nior com­pa­ny ex­ecs were in­fect­ed at the meet­ing, which drew in staffers from Eu­rope, but the com­pa­ny re­mains grim­ly de­ter­mined not to iden­ti­fy who spread the virus at the Cowen con­fer­ence days lat­er. That in­cludes CEO Michel Vounatsos, who won’t even say if he’s been test­ed for Covid-19.

I had a chance to weigh in on the ar­ti­cle, say­ing:

“The smartest peo­ple in health care and drug de­vel­op­ment — and they were com­plete­ly obliv­i­ous to the biggest thing that was about to shat­ter their world.”

As I al­so not­ed to the writ­ers, it’s one thing for Bio­gen to have been blind­sided by the burst of in­fec­tions at their meet­ing, as the pan­dem­ic was brew­ing. But by the time of the Cowen meet­ing just days lat­er, while Ver­tex and Seat­tle Ge­net­ics were pulling out, se­nior ex­ecs can be fair­ly crit­i­cized for not be­ing more cau­tious as it be­came ap­par­ent that the out­break was head­ed here.

One day top ex­ecs may be more trans­par­ent about the dan­ger they posed to their staff, and the coun­try. — John Car­roll

Cell­tri­on plunges in­to Covid-19 work in search of a “su­per an­ti­body” and cock­tail ther­a­py

Work­ing with the Ko­re­an CDC, Cell­tri­on says it has iden­ti­fied hun­dreds of an­ti­bod­ies with po­ten­tial in treat­ing Covid-19 and now plans to be­gin an­i­mal test­ing in search of a “su­per”an­ti­body or a cock­tail that could be used to fight se­ri­ous in­fec­tions.

Re­searchers around the globe have been work­ing on dis­cov­er­ing an­ti­bod­ies that are par­tic­u­lar­ly suit­ed to the pan­dem­ic fight. For now, Gilead leads that race with its re­pur­posed remde­sivir, but the de­bate over its full po­ten­tial won’t be de­cid­ed un­til the com­pa­ny reads out piv­otal da­ta in the com­ing weeks and months.

Ki-Sung Kwon, Head of R&D at Cell­tri­on, said:

“We are bring­ing our full re­sources and ex­per­tise to over­come this glob­al health cri­sis and are glad to have iden­ti­fied these an­ti­bod­ies soon­er than pre­vi­ous­ly ex­pect­ed. These an­ti­bod­ies can recog­nise mul­ti­ple epi­topes, thus in­creas­ing the prob­a­bil­i­ty of non­spe­cif­ic anti­gen bind­ing. Giv­en the ex­pe­dit­ed de­vel­op­ment process of our an­tivi­ral an­ti­body treat­ment, we an­tic­i­pate mov­ing to first-in-hu­man clin­i­cal tri­als in Ju­ly. We are al­so on track with the de­vel­op­ment of a ‘su­per an­ti­body’ or ‘an an­ti­body cock­tail’ and the launch of a rapid self-test­ing di­ag­nos­tic kit in the sum­mer of this year.” — John Car­roll

Sin­ga­pore re­stric­tions force Aslan to pause en­roll­ment, pon­der a switch to Aus­tralia

You can add Aslan $ASLN to the long, long list of biotechs en­dur­ing tri­al de­lays due to the out­break.

Af­ter re­peat­ed set­backs in the clin­ic, the Sin­ga­pore-based biotech says that it is paus­ing re­cruit­ment for a study of ASLAN004 in mod­er­ate to se­vere atopic der­mati­tis. The com­pa­ny said lo­cal re­stric­tions forced them to halt en­rolling more pa­tients, adding that they’re look­ing at switch­ing their tri­al fo­cus to Aus­tralia — where re­searchers and CROs have long held close ties to Asian de­vel­op­ers. — John Car­roll

NIH adds Eli Lil­ly’s Olu­mi­ant to the mas­ter pro­to­col for Covid-19

As Big Phar­mas race to de­ploy their ap­proved an­ti-in­flam­ma­to­ry drugs in the treat­ment of pa­tients with se­ri­ous Covid-19, Eli Lil­ly is throw­ing Olu­mi­ant (baric­i­tinib) in­to the mix.

The NIH has added the rheuma­toid arthri­tis drug to its mas­ter pro­to­col dubbed Adap­tive COVID-19 Treat­ment Tri­al (ACTT), the first since they be­gan the tri­al with Gilead’s remde­sivir. Lil­ly said re­sults are ex­pect­ed in two months.

“Lil­ly is mov­ing at top speed and us­ing all avail­able re­sources to help fight this pan­dem­ic,” said Daniel Skovron­sky, chief sci­en­tif­ic of­fi­cer and pres­i­dent of Lil­ly Re­search Lab­o­ra­to­ries.

In ad­di­tion to test­ing Olu­mi­ant as part of an NIH-led tri­al, the com­pa­ny al­so plans to move LY3127804 in­to Phase II. The in­ves­ti­ga­tion­al mon­o­clon­al an­ti­body blocks an­giopoi­etin 2 (Ang2), a growth fac­tor they say is el­e­vat­ed in pa­tients with acute res­pi­ra­to­ry dis­tress syn­drome. As with a num­ber of ex­per­i­men­tal agents in the mod­er­ate to se­vere set­ting, the goal is to re­duce the pro­gres­sion to ARDS or the need for me­chan­i­cal ven­ti­la­tion.

A month ago Lil­ly kicked off a col­lab­o­ra­tion with Cana­di­an biotech Ab­Cellera to dis­cov­er an­ti­bod­ies that can fight the vi­ral in­fec­tion, eye­ing first-in-hu­man test­ing by late Ju­ly. — Am­ber Tong

Gilead posts ear­ly remde­sivir da­ta, draw­ing a cheer

Re­sults from a small, sin­gle-arm study in­volv­ing 53 com­pas­sion­ate use cas­es of se­vere­ly af­flict­ed Covid-19 pa­tients sug­gest Gilead’s hot­ly an­tic­i­pat­ed an­tivi­ral, remde­sivir, might be in­duc­ing clin­i­cal im­prove­ment. Al­though the ben­e­fits have to be borne out in on­go­ing Phase III stud­ies, SVB Leerink an­a­lyst Ge­of­frey Porges be­lieves the drug should be avail­able for lim­it­ed use by mid-May. (End­points link)

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.