Scot Roberts, Altimmune CSO

Why mu­cos­al im­mu­ni­ty may be re­quired to end the pan­dem­ic

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Fol­low­ing the re­cent emer­gency use au­tho­riza­tions of mul­ti­ple vac­cines for COVID-19, the first wave of peo­ple have al­ready be­gun the vac­ci­na­tion process — a tru­ly re­mark­able mile­stone. As some­one who has ded­i­cat­ed his ca­reer to drug de­vel­op­ment and dis­cov­ery fo­cused on vi­ral vec­tors and an­tivi­ral ther­a­pies, I can tell you that the sci­ence has moved fast, and we have every rea­son to cel­e­brate. The da­ta on these vac­cines are good. They are well stud­ied and their po­ten­tial for pub­lic health is promis­ing.

How­ev­er, I can al­so tell you that this is like­ly on­ly the be­gin­ning. I wor­ry that the roll­out of the cur­rent vac­cines will cre­ate a false sense of se­cu­ri­ty among a large pop­u­la­tion of peo­ple. There is a sce­nario that we need to be pre­pared for and one that could pos­si­bly de­rail our fight against this virus: These first-gen­er­a­tion vac­cines will be able to ef­fec­tive­ly block dis­ease, but not the trans­mis­sion of the SARS-CoV-2 virus.

Pfiz­er, Mod­er­na and near­ly every oth­er phar­ma­ceu­ti­cal com­pa­ny are pro­duc­ing in­jectable vac­cines. Their pro­tec­tive pow­er re­sults from sys­temic im­mu­ni­ty, mean­ing that they gen­er­ate an­ti­bod­ies that cir­cu­late in the blood to oth­er parts of the body. They were au­tho­rized based on their abil­i­ty to block the de­vel­op­ment of dis­ease, which is not the same as the abil­i­ty to in­hib­it vi­ral in­fec­tion or trans­mis­sion.

The best way to block both vi­ral in­fec­tion and trans­mis­sion is by in­duc­ing a spe­cial type of im­mune re­sponse called mu­cos­al im­mu­ni­ty. Mu­cos­al im­mu­ni­ty pro­tects the parts of the body that are in con­tact with the en­vi­ron­ment, and in the case of a res­pi­ra­to­ry pathogen, that means the nasal cav­i­ty and the lungs. Be­cause it is a lo­cal­ized type of re­sponse, a vac­cine needs to be de­liv­ered to the ap­pro­pri­ate com­part­ment if mu­cos­al im­mu­ni­ty is to be stim­u­lat­ed. In the case of a res­pi­ra­to­ry pathogen like SARS-CoV-2 that means in­tranasal vac­cine ad­min­is­tra­tion.

With­out mu­cos­al im­mu­ni­ty, the virus may con­tin­ue to thrive in a per­son’s nasal cav­i­ty al­low­ing for easy trans­mis­sion. This is why wear­ing a mask, even af­ter vac­ci­na­tion with an in­tra­mus­cu­lar vac­cine, will re­main crit­i­cal.

Thank­ful­ly, sci­en­tists, in­clud­ing our team, are work­ing on next gen­er­a­tion vac­cines that can elic­it mu­cos­al im­mu­ni­ty, in­clud­ing in­tranasal vac­cines that have the po­ten­tial to elic­it an im­mune re­sponse in the nose as well as sys­tem­i­cal­ly. This type of broad­er im­mune re­sponse could de­fend against in­fec­tion, dis­ease and trans­mis­sion. In fact, an in­tranasal vac­cine could al­so be used in com­bi­na­tion with an in­tra­mus­cu­lar vac­cine to elic­it mu­cos­al im­mu­ni­ty and serve as a boost­er for sys­temic im­mu­ni­ty.

We have a prece­dent. Flu­Mist is a live but weak­ened in­fluen­za vac­cine de­liv­ered by in­tranasal spray and this type of mu­cos­al vac­cine has been shown to de­crease the trans­mis­sion of in­fluen­za to close con­tacts.

Be­cause of their po­ten­tial to block trans­mis­sion, vac­cines that stim­u­late nasal mu­cos­al im­mu­ni­ty may be es­sen­tial to bring the pan­dem­ic to an end. How­ev­er, it will take a lit­tle more time to de­vel­op and test these new­er vac­cines as we can’t sac­ri­fice ef­fi­ca­cy and safe­ty for speed.

Un­til then, the pub­lic must take pre­cau­tions to keep this virus un­der con­trol. Even af­ter vac­ci­na­tion, our best weapon is so­cial dis­tanc­ing, test­ing and masks. They must re­main a core part of our pub­lic health strat­e­gy even as the first-gen­er­a­tion vac­cines roll out.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.