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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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