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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

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Opin­ion: CMS needs to do FDA’s job and lim­it the use of Bio­gen’s pricey new Alzheimer’s drug

Now that the FDA has approved Biogen’s expensive new Alzheimer’s drug with little clinical benefit potential, but plenty of potential to speed the bankruptcy of the government’s health care program for seniors, it’ll be up to the Centers for Medicare and Medicaid Services to limit payment for it and drive the conversation on access.

While such access decisions are normally reserved for the FDA, the agency abdicated its responsibility because of the wide label and because it’s allowing Biogen to take almost a decade to figure out if aducanumab actually works.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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