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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more

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UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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As­traZeneca, Dai­ichi Sankyo un­cork new TNBC da­ta for 2nd part­nered ADC — and it's adding more heat un­der Gilead­'s Trodelvy

After the approval of their partnered anti-HER2 antibody-drug conjugate earlier this year, AstraZeneca and Daiichi Sankyo are riding high on the promise of their blooming partnership. Now a second ADC is showing promise in hard-to-treat breast cancer, and the companies have their eyes set on their only approved competitor in the space.

AstraZeneca and Daiichi Sankyo’s next-gen ADC datopotamab deruxtecan posted a 43% response rate and five confirmed complete or partial responses among 21 patients with triple-negative breast cancer, according to cohort data from the TROPION-PanTumor01 Phase I study presented Saturday at the virtual ESMO Breast annual meeting.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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