Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Mon­cef Slaoui hasn’t start­ed mak­ing plans for his sum­mer va­ca­tion next year. But he of­fers high odds that all Amer­i­cans will be able to do that in the not too dis­tant fu­ture.

In an in­ter­view with a pair of sym­pa­thet­ic pod­cast­ers at the con­ser­v­a­tive Amer­i­can En­ter­prise In­sti­tute, Slaoui pro­vides an ed­u­ca­tion to lis­ten­ers on how any drug or vac­cine can be sped through tri­als. And he leaves the door wide open to the no­tion that the lead­ing vac­cine de­vel­op­ers can demon­strate ef­fi­ca­cy and safe­ty in a com­pelling fash­ion as ear­ly as Oc­to­ber — or as late as the end of this year.

But Slaoui says he is quite con­fi­dent that based on what he knows now, there’s good rea­son to be hope­ful that vac­cines will be avail­able in suf­fi­cient quan­ti­ty to cov­er all the at-risk pop­u­la­tion in the US — up to 40 mil­lion peo­ple — by the end of Feb­ru­ary. And he’s look­ing for sev­er­al vac­cines to cross the fin­ish line, so that the ex­perts can choose which are the most like­ly to work based on de­mo­graph­ics and risk.

Slaoui’s po­si­tion on this will be close­ly fol­lowed. He end­ed a 30-year stint at GSK as chair­man of the vac­cines group, top­ping it off with the high­ly suc­cess­ful Shin­grix pro­gram. With his switch to OWS, Slaoui di­vest­ed his Mod­er­na shares — jump­ing from the board of one of the lead­ing vac­cine de­vel­op­ers to OWS — but kept his GSK stock, which trig­gered some crit­i­cism that he’s still clear­ly deeply re­sent­ful about.

For crit­ics, it’s all fod­der for dis­cus­sion as every­one fo­cus­es in on the high­ly po­tent top­ic of whether Pres­i­dent Trump will force through a vac­cine an­nounce­ment — herald­ing a suc­cess­ful piv­otal tri­al — in time to in­flu­ence the elec­tion. And like every ex­pert in the gov­ern­ment, from FDA com­mis­sion­er Stephen Hahn to NI­AID di­rec­tor An­tho­ny Fau­ci, Slaoui says the sci­ence will be all that mat­ters.

Draw­ing from a tran­script of the call, here’s Slaoui de­scrib­ing in de­tail how vac­cine de­vel­op­ment is done:

We’re run­ning very large tri­als be­cause they al­low us to reach ef­fi­ca­cy faster, not be­cause there’s an elec­tion, be­cause there’s thou­sands of peo­ple dy­ing every day. And the da­ta will be de­fined by the num­ber of cas­es. There is no date. It’s im­pos­si­ble to give you a date. I have been asked about dates, and I didn’t feel any pres­sure what­so­ev­er to say da­ta will de­fine the date. When we have the num­ber of cas­es re­quired and then we have an in­de­pen­dent da­ta safe­ty mon­i­tor­ing board in­de­pen­dent­ly look in­to the da­ta and says we need to con­tin­ue, we need to stop be­cause this is not work­ing, or we need to stop be­cause this is work­ing too well, it’s un­eth­i­cal to con­tin­ue, we now need to start to give the vac­cine to the place­bo arm in the tri­al and to oth­er peo­ple to con­sid­er, then that will be the end. So the end of the tri­als is com­plete­ly in­de­pen­dent of the op­er­a­tion or any­body in­volved in the op­er­a­tion. It’s ac­tu­al­ly great aca­d­e­m­ic ex­perts, whose names are un­known to the pub­lic who are look­ing in­to that da­ta. And this is how all clin­i­cal tri­als are al­ways done. That is how clin­i­cal tri­als are done.

So when will we know?

So the da­ta will dic­tate, the facts will dic­tate. We may have the end point in Oc­to­ber. We may have it in No­vem­ber 4th, who knows? We may have it in De­cem­ber 15th. That’s the an­swer, and to be hon­est, on a per­son­al ba­sis, I would re­sign in­stant­ly if I was forced to do some­thing that I thought would be in­ap­pro­pri­ate.

From the pod­cast­ers: What’s your time­line? Or what’s your thought on that?

I hope we will have enough dos­es of vac­cines in the first two months of 2021 to im­mu­nize the at risk pop­u­la­tions in the US, vac­cines that could have shown ef­fi­ca­cy and ap­proved in­de­pen­dent­ly by the FDA. And I’m talk­ing about maybe the 30 to 40 mil­lion most sus­cep­ti­ble peo­ple in the US across maybe De­cem­ber, Jan­u­ary, Feb­ru­ary.

And then and I think that should de­crease dra­mat­i­cal­ly the bur­den of this dis­ease on so­ci­ety in gen­er­al. Be­cause, as you know, most of the bur­den of the dis­ease is on a high risk pop­u­la­tion. Plus the sec­ondary ef­fect of over­whelm­ing the hos­pi­tal sys­tems, et cetera, which has an im­pact on oth­er pop­u­la­tions for oth­er rea­sons. And I think, from there on, it’s go­ing to be a grad­ual process that will be a bal­ance be­tween the ben­e­fits/risks that the vac­cines will have shown and the risk of par­tic­u­lar sub­pop­u­la­tion.

For in­stance, frankly, im­mu­niz­ing the pe­di­atric pop­u­la­tion, tod­dlers, et cetera, will be some­thing that should be re­al­ly far be­cause they have 70 or 80 years to live. And we need prob­a­bly there to use plat­form tech­nolo­gies that are well un­der­stood in the long range, such as pro­tein based vac­cines, et cetera. We are for­tu­nate that most­ly in that pop­u­la­tion the dis­ease bur­den is very, very low. And so, I think there will be a gra­di­ent of views. But prob­a­bly be­tween the first quar­ter and the sec­ond quar­ter of 2021, the most at risk pop­u­la­tions will have been, I hope, im­mu­nized. And life, I would ex­pect… I hope next sum­mer I can have a va­ca­tion, nor­mal va­ca­tion.

What­ev­er hap­pens to his va­ca­tion plans, one thing seems cer­tain. Mil­lions of peo­ple will be ar­gu­ing over the de­vel­op­ment time­line right un­til the elec­tion is de­cid­ed.

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

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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 earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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