Covid-19 roundup: The pan­dem­ic bear — You think a vac­cine and herd im­mu­ni­ty are just months away? Dream on, says biotech an­a­lyst; plus more

You’ve all heard the rosiest sce­nar­ios by now.

Vac­cines are rac­ing through clin­i­cal de­vel­op­ment at un­heard-of speed, helped along by reg­u­la­tors work­ing round the clock to beat Covid-19. And man­u­fac­tur­ers have been lay­ing the ground­work for mass pro­duc­tion ahead of Phase I re­sults.

The first wave of jabs and meds could break in a mat­ter of months. With the NIH en­dors­ing such re­marks as “We’ll have a vac­cine by Sep­tem­ber,” every­one from law­mak­ers to in­vestors and the gen­er­al pub­lic have been will­ing to buy in­to the no­tion that sal­va­tion lies right around the cor­ner.

Then along comes a promi­nent an­a­lyst to pour a buck­et of cold wa­ter on your hope of turn­ing the tide by Christ­mas.

SVB Leerink’s Ge­of­frey Porges took stock of the promise of glob­al pan­dem­ic re­lief and of­fered to burst that lit­tle bub­ble for free.

For Porges, the on­ly thing that lies around the cor­ner is … an­oth­er cor­ner. And then more cor­ners. The path to a vac­cine is long and hard, he notes. And the re­al­i­ty of that should be fac­tored in as we size up the fu­ture.

In our ex­pe­ri­ence it is very un­like­ly that we will have a gen­er­al use vac­cine in the 6-18 month ac­cel­er­at­ed time­frame that is be­ing dis­cussed. We be­lieve that a 2-3 year time­line is the most op­ti­mistic for see­ing a gen­er­al use vac­cine in­tro­duced, and as im­por­tant­ly, in the re­mote pos­si­bil­i­ty that an ap­proved, ef­fec­tive, safe gen­er­al use vac­cine was avail­able a year from now, it would still take sev­er­al years to con­fer suf­fi­cient “herd im­mu­ni­ty” to pre­vent en­dem­ic spread of COVID19. We be­lieve that achiev­ing herd im­mu­ni­ty suf­fi­cient to pre­vent epi­dem­ic spread is like­ly to oc­cur in 2023 or 2024, giv­en a high­ly ac­cel­er­at­ed time­line for vac­cine de­vel­op­ment in­clud­ing demon­stra­tion of safe­ty and ef­fi­ca­cy in hu­mans, and then de­sign, de­vel­op­ment and im­ple­men­ta­tion of a mass im­mu­niza­tion pro­gram suf­fi­cient to get to a 70-80% im­mune thresh­old.

And that, he adds, is his “op­ti­mistic” pro­jec­tion. It could be much, much worse.

Sure, there are more than 70 vac­cine pro­grams go­ing on now. But for Porges, if you add it all up, it’s like hand­ing some­one a dart and giv­ing them 1 chance to hit a bulls eye at 24 feet — 3 times the reg­u­la­tion dis­tance. He’s al­so not en­thu­si­as­tic that the clos­est vac­cines to re­al­i­ty — like the mR­NA vac­cines — can pass muster quick­ly, as they are com­plete­ly un­proven.

Add to that a new virus we don’t com­plete­ly un­der­stand and you get a bet­ter idea of where Porges is com­ing from.

We do have the lux­u­ry of many dif­fer­ent shots on goal with 70+ pro­grams un­der­way (to mix our sport­ing metaphors), but each one of these on­ly has the same low prob­a­bil­i­ty and most of them can’t de­liv­er on the op­ti­mistic time­lines now dom­i­nat­ing pol­i­cy mak­er’s and in­vestor’s out­looks.

The on­ly re­al shot at get­ting a vac­cine in­to fast use is by re­quir­ing peo­ple to take a shot of some­thing that no one knows the full sto­ry on — with safe­ty and ef­fi­ca­cy iffy at best, notes the an­a­lyst. And that in­cludes im­mu­niz­ing low-risk peo­ple for the sake of the old­er gen­er­a­tion.

So give it 2-3 years for an ef­fec­tive vac­cine, then 1-3 years for herd im­mu­ni­ty. — John Car­roll

Alex­ion plots quick PhI­II to eval­u­ate whether Ul­tomiris can boost sur­vival rates

Al­most a month af­ter in­di­cat­ing it’s look­ing in­to test­ing its star C5 in­hibitor Soliris for hos­pi­tal­ized pa­tients with Covid-19, Alex­ion is go­ing straight in­to Phase III with its fol­low-up drug, Ul­tomiris. The study will in­volve around 270 pa­tients suf­fer­ing from se­vere pneu­mo­nia, acute lung in­jury or acute res­pi­ra­to­ry dis­tress syn­drome and in­ves­ti­gate whether Ul­tomiris can help them sur­vive past 29 days.

The de­ci­sion was based on “ear­ly anec­do­tal in­for­ma­tion avail­able from com­pas­sion­ate use cas­es in mul­ti­ple coun­tries” as well as pre­clin­i­cal da­ta sug­gest­ing that in­hi­bi­tion of ter­mi­nal com­ple­ment can low­er cy­tokine and chemokine lev­els, there­by re­duc­ing lung in­flam­ma­tion.

In the Phase III tri­al — which will in­clude a con­trol arm re­ceiv­ing best sup­port­ive treat­ment — in­ves­ti­ga­tors will al­so as­sess the need for me­chan­i­cal ven­ti­la­tion, oxy­gena­tion, du­ra­tion of ICU stay and hos­pi­tal­iza­tion, in ad­di­tion to safe­ty as sec­ondary end­points. Mean­while Alex­ion is still run­ning an ex­pand­ed ac­cess pro­gram in the US and France for Soliris. — Am­ber Tong

So­ci­ety needs to pitch in to shore up drug, vac­cine man­u­fac­tur­ing

Apart from de­vel­op­ing an ef­fi­ca­cious and safe vac­cine, a com­pa­ny’s abil­i­ty to man­u­fac­ture the vac­cine swift­ly is para­mount. Ex­perts, in­clud­ing NI­AID di­rec­tor An­tho­ny Fau­ci, have stressed that the best strat­e­gy is for mak­ers to shore up man­u­fac­tur­ing even be­fore they have con­crete ev­i­dence of ef­fi­ca­cy so that vac­cines can be de­ployed quick­ly and wide­ly if proven to be safe and po­tent.

Now, chiefs of phar­ma­ceu­ti­cal com­pa­nies are ask­ing gov­ern­ments to work to­geth­er and pro­vide sub­stan­tial fund­ing to as­sist with shoring up pro­duc­tion. “In­dus­try alone can’t pro­vide all the in­vest­ment need­ed now for bil­lions of dos­es,” Sanofi EVP David Loew said in an in­ter­view with the Fi­nan­cial Times.

Apart from vac­cines, there is a glob­al des­per­a­tion for raw ma­te­ri­als for ex­ist­ing treat­ments be­ing re­pur­posed and test­ing. Of par­tic­u­lar con­cern are de­vel­op­ing poor­er na­tions, whose ac­cess to med­ical sup­plies is lim­it­ed by scant­er re­sources. Ex­ec­u­tives al­so wor­ry that the Covid-19 sit­u­a­tion will echo what hap­pened in the af­ter­math of pre­vi­ous out­breaks, such as Ebo­la and the 2009 flu pan­dem­ic — as the dust be­gan to set­tle, com­pa­nies strug­gled to main­tain fund­ing to de­vel­op po­ten­tial drugs and vac­cines for fu­ture out­breaks af­ter gov­ern­ments cut them off.

“The in­vest­ment re­quired is too large for any com­pa­ny,” said Take­da chief Christophe We­ber to the FT. “So­ci­ety will have to fi­nance this huge in­vest­ment. My fear is the same as af­ter the flu pan­dem­ic, when every­body los­es in­ter­est.” — Na­tal­ie Grover

Trump ad­vi­sor Navar­ro as­serts Chi­na is with­hold­ing da­ta to win vac­cine race 

On Sun­day, White House ad­vi­sor Pe­ter Navar­ro took to Fox News to ac­cuse Chi­na of tak­ing a suite of ac­tions to wors­en the on­go­ing coro­n­avirus cri­sis.

“First of all, the virus was spawned in Chi­na. Sec­ond of all, they hid the virus be­hind the shield of the World Health Or­ga­ni­za­tion. The third thing they did was ba­si­cal­ly hoard per­son­al pro­tec­tive equip­ment and now they’re prof­i­teer­ing from it,” Navar­ro said on Fox News pro­gram Sun­day Morn­ing Fu­tures.

The out­spo­ken crit­ic of Chi­na, who has been tasked by Pres­i­dent Trump to work on sup­ply is­sues re­lat­ing to the  pan­dem­ic, on Mon­day sug­gest­ed on Fox News that the coun­try is with­hold­ing da­ta about ear­ly coro­n­avirus in­fec­tions in or­der to be the first to de­vel­op a vac­cine.

“One of the rea­sons that they may not have let us in and giv­en us the da­ta on this virus ear­ly, is they’re rac­ing to get a vac­cine and they think this is just a com­pet­i­tive busi­ness race, it’s a busi­ness propo­si­tion so that they can sell the vac­cines to the world,” he said.

The race to de­vel­op a vac­cine has heat­ed up, with Chi­na’s CanSi­no as one of a hand­ful of de­vel­op­ers with a vac­cine in hu­man test­ing. — Na­tal­ie Grover

Brazil hy­drox­y­chloro­quine tri­al sus­pend­ed due to eth­i­cal con­cerns 

A new study from Brazil, which sug­gest­ed the com­bi­na­tion of hy­drox­y­chloro­quine and azithromycin had a sig­nif­i­cant­ly pos­i­tive im­pact on ear­ly-stage sus­pect­ed Covid-19 cas­es, was post­ed as a pre­lim­i­nary man­u­script draft on Drop­box last week.

On Mon­day, the tri­al was sus­pend­ed by the Na­tion­al Com­mis­sion for Ethics in Re­search (Conep) af­ter the agency dis­cov­ered that test­ing was ini­ti­at­ed be­fore the com­pa­ny, a São Paulo-based hos­pi­tal chain, re­ceived the green­light to car­ry out the re­search. The re­searchers in charge were sum­moned for a hear­ing this Mon­day af­ter­noon with the agency to pro­vide clar­i­fi­ca­tion on sus­pect­ed ir­reg­u­lar­i­ties, ac­cord­ing to a re­port.

There were a num­ber of in­con­sis­ten­cies iden­ti­fied. For one, re­searchers had told Conep that pa­tients with a con­firmed di­ag­no­sis of Covid-19 would be in­clud­ed in the tri­al, but the man­u­script re­leased sug­gest­ed that par­tic­i­pants dis­play­ing flu-like symp­toms with­out con­firmed Covid-19 in­fec­tions were in­clud­ed in the tri­al. Ini­tial­ly, the re­searchers al­so in­di­cat­ed the tri­al would en­roll 200 par­tic­i­pants, but the man­u­script the num­ber was clos­er to 700, the re­port said. — Na­tal­ie Grover

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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