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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

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 has vowed not to let politics overrule 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 the FDA and other health agencies under his purview of their rule making 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.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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J&J re­leas­es PhI­II safe­ty blue­print for Covid-19 vac­cine tri­al. How does it stack up to Mod­er­na, Pfiz­er and As­traZeneca?

Along with the initiation of its Phase III Covid-19 vaccine study announced Wednesday morning, Johnson & Johnson also released its trial protocol, giving an inside look at how the company is conducting its late-stage research.

The move comes after the other three companies conducting Phase III’s in the US — Moderna, Pfizer and AstraZeneca — each disclosed their own trial blueprints within the last week. Though the release of such protocols is typically done after trials have been completed, drug developers had come under intense pressure after a brief safety scare in an AstraZeneca trial and amid growing concern of a politically motivated vaccine authorization.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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