Moderna CEO Stéphane Bancel (AP Images)

The lead­ers in the race to de­vel­op a Covid-19 vac­cine say they could have piv­otal da­ta in Oc­to­ber — but Trump claims FDA is slow­ing re­cruit­ment

Late Fri­day night Mod­er­na tweet­ed that their Phase III study had come close to the halfway mark in re­cruit­ing the 30,000 or so sub­jects need­ed for the piv­otal test of their Covid-19 vac­cine mR­NA-1273.

Bioreg­num Opin­ion Col­umn by John Car­roll

So I thought it was a good time to catch up with CEO Stéphane Ban­cel on the tim­ing of the read­out, which is of in­tense in­ter­est around the world — and par­tic­u­lar­ly in Wash­ing­ton DC, where the top reg­u­la­tors and sci­en­tists in­volved re­peat­ed­ly in­sist they won’t tol­er­ate any po­lit­i­cal in­ter­fer­ence in push­ing a pre­ma­ture an­nounce­ment of a win ahead of the elec­tion No­vem­ber 3rd.

In re­sponse to my email query, Ban­cel ob­served:

We have said we should be done in Sep­tem­ber with en­roll­ment.

Event dri­ven read out.

So the 2 key dri­vers of when we will know is

In­fec­tion rate

Ef­fi­ca­cy (a high ef­fi­ca­cy vac­cine will read out soon­er than a low ef­fi­ca­cy vac­cine)

Base case sce­nario is No­vem­ber read out

Best is Oc­to­ber

This is in line with what Pfiz­er and BioN­Tech ex­ecs have been say­ing about their mR­NA can­di­date. On Thurs­day night Pfiz­er put out a state­ment say­ing that they had re­cruit­ed more than 11,000 sub­jects for their piv­otal and the in­ves­ti­ga­tors were in line for a read out as ear­ly as Oc­to­ber.

The faster they re­cruit, the quick­er they can get the sec­ond shot in, and as­sess ef­fi­ca­cy. For Mod­er­na $MR­NA the sec­ond shot comes on day 29, and for Pfiz­er/BioN­Tech it’s day 21. And that leaves the lead­ing play­ers neck-and-neck.

It’s worth not­ing here that it typ­i­cal­ly takes years, not months, to get a vac­cine through de­vel­op­ment and on­to the mar­ket. Here’s our rank­ing of the 28 vac­cines in or near the clin­ic.

Pe­ter Marks, FDA

At this point just about every promi­nent gov­ern­ment of­fi­cial con­nect­ed to this has com­plete­ly re­ject­ed the idea that po­lit­i­cal in­flu­ence from the Trump White House would be al­lowed to push a pos­i­tive de­c­la­ra­tion ahead of the elec­tion. That was capped by Pe­ter Marks, the CBER chief who flat out vowed to re­sign if he saw any med­dling in the time­line.

But Pres­i­dent Trump isn’t mak­ing it easy for the FDA. On Sat­ur­day morn­ing Trump de­clared that the FDA was pur­pose­ful­ly slow­ing down re­cruit­ment for vac­cine and drug tri­als. And he sug­gest­ed the “deep state” in­side the agency could be pulling strings to trip up in­ves­ti­ga­tors, urg­ing com­mis­sion­er Stephen Hahn to speed things up in his re­marks.

There’s no ev­i­dence at all of any “deep state” an­ti-Trump group op­er­at­ing at the FDA.

Trump fol­lowed up with a tweet crit­i­ciz­ing the FDA — again — for yank­ing the emer­gency use au­tho­riza­tion for his fa­vorite Covid-19 drug hy­droxy, which has been wide­ly panned af­ter mul­ti­ple tri­al fail­ures. But so far, Hahn hasn’t budged on that. And any move now would in­stant­ly reignite charges of po­lit­i­cal in­flu­ence.

Trump’s tweet earned a quick re­tort from House Speak­er Nan­cy Pelosi, who called it a “dan­ger­ous at­tempt to in­ject him­self in­to the sci­en­tif­ic de­ci­sions” of the the FDA.

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.