Anthony Fauci (Greg Nash/Pool via AP Images)

Fau­ci calls for de­vel­op­ment of pan-coro­n­avirus and in­tranasal vac­cines in fight against Covid vari­ants

Even as vac­cine man­u­fac­tur­ers plow a path to mar­ket for Omi­cron-spe­cif­ic boost­er shots this fall, NI­AID di­rec­tor An­tho­ny Fau­ci’s mes­sage is clear: “Our job is not done.”

Fau­ci, who al­so serves as chief med­ical ad­vi­sor to Pres­i­dent Joe Biden, took the White House podi­um on Tues­day to of­fer a glimpse at where next-gen­er­a­tion vac­cines are head­ed — specif­i­cal­ly high­light­ing the need for pan-coro­n­avirus can­di­dates and mu­cos­al op­tions that can be ad­min­is­tered in­tranasal­ly.

“In­no­v­a­tive ap­proach­es are clear­ly need­ed to in­duce broad and durable pro­tec­tion against coro­n­avirus­es known and un­known,” he said.

At the end of last month, the FDA rec­om­mend­ed that vac­cine man­u­fac­tur­ers like Pfiz­er and Mod­er­na move for­ward with Omi­cron-spe­cif­ic for­mu­la­tions, which may be avail­able in ear­ly- to mid-fall.

Thanks to cur­rent vac­cines, we’ve avert­ed well over two mil­lion deaths and about a tril­lion dol­lars in health­care costs, Fau­ci said. How­ev­er, vac­cine de­vel­op­ment is be­com­ing in­creas­ing­ly com­pli­cat­ed, as we’re now see­ing “sub­lin­eages of sub­lin­eages” of Covid vari­ants.

“These in­jectable vac­cines do a great job at pre­vent­ing se­vere dis­ease, but they do lit­tle to pre­vent in­fec­tion and trans­mis­sion, and trans­mis­sion is the en­gine of vari­ant evo­lu­tion,” said Mar­tin Moore, CSO and co­founder of Meis­sa Vac­cines.

Down the road, Fau­ci ad­vo­cat­ed for pan-coro­n­avirus vac­cines, or mu­cos­al op­tions that could po­ten­tial­ly stop trans­mis­sion in its tracks.

“When you have a mu­cos­al, and in this case, in­tranasal, what you do is you stim­u­late at the lo­cal lev­el,” Fau­ci said dur­ing the sum­mit, which was broad­cast live on Zoom. “The goal of that is not on­ly to pro­tect against dis­ease, but to pro­tect against ac­qui­si­tion and by ac­qui­si­tion, trans­mis­sion. And that’s re­al­ly the holy grail.”

Akiko Iwasa­ki

Cur­rent vac­cines in­duce ro­bust sys­temic im­mune re­spons­es, but do not in­duce a mu­cos­al re­sponse, ac­cord­ing to Akiko Iwasa­ki, an im­munol­o­gy pro­fes­sor at Yale Uni­ver­si­ty. She’s al­so the co-founder of Xanadu Bio, a Yale spin­out look­ing to bring an in­tranasal Covid can­di­date in­to the clin­ic. Mu­cos­al vac­cines are de­signed to pre­vent a virus from ever get­ting to a host cell, like putting a guard out­side your house to pro­tect from in­vaders, Iwasa­ki said.

Iwasa­ki re­cent­ly co-au­thored a pa­per in Sci­ence Im­munol­o­gy along­side Scripps Re­search Trans­la­tion­al In­sti­tute founder Er­ic Topol that ad­vo­cates for an ac­cel­er­at­ed ini­tia­tive for in­tranasal Covid-19 vac­cines, sim­i­lar to Op­er­a­tion Warp Speed.

“We know from 200 years of vac­ci­nol­o­gy … that vac­cines that mim­ic nat­ur­al in­fec­tion tend to work best,” Moore said. “No one here to­day can tell you that mu­cos­al COVID vac­cines work, we’re not there yet. We need clin­i­cal ef­fi­ca­cy da­ta to an­swer that ques­tion, and that’s why we’re here.”

Paul Bur­ton

Man­u­fac­tur­ing is al­so “a key part of the fu­ture,” Mod­er­na’s CMO Paul Bur­ton said at the sum­mit, adding that the com­pa­ny has re­cent­ly struck deals to build new plants and R&D sites in Aus­tralia, the Unit­ed King­dom, Cana­da and Kenya.

“We have to con­tin­ue these dis­cus­sions, con­tin­ue these col­lab­o­ra­tions to in­still con­fi­dence,” Bur­ton said. “Get­ting that con­fi­dence and then the abil­i­ty to get these shots made in coun­tries and in­to peo­ple’s arms I think is how we’re go­ing to con­tin­ue to get out of the pan­dem­ic.”

Pfiz­er bio­phar­ma group pres­i­dent An­gela Hwang added that the de­vel­op­ers con­tin­ue to im­ple­ment lessons learned from the pan­dem­ic to make the process more ef­fi­cient.

“Prob­a­bly two and a half bil­lion peo­ple have re­ceived the Pfiz­er vac­cine,” she said. “That’s an in­cred­i­ble wealth of re­al world ev­i­dence that we’re sit­ting on. And so I think that we have a great op­por­tu­ni­ty, hav­ing that strong depth and breadth of da­ta, to use that to al­so help us to un­der­stand, how can we de­sign new ther­a­pies?”

*A cor­rec­tion has been made to the at­tri­bu­tion of two quotes by Mar­tin Moore.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.