Linda Marbán, Capricor CEO

Ex­clu­sive: Johns Hop­kins pro­fes­sor and biotech col­leagues tout new tech to test Covid-19 vac­cine re­sponse

Vari­ants to the SARS-CoV-2 virus have emerged of late as yet an­oth­er threat to a pan­dem­ic that’s al­ready killed over 2.2 mil­lion peo­ple world­wide.

The Covid-19 vac­cines al­ready on the mar­ket have so far man­aged to re­tain at least some lev­el of ef­fi­ca­cy in treat­ing new, more in­fec­tious strains of the res­pi­ra­to­ry virus — but con­cern about oth­er mu­ta­tions re­mains pal­pa­ble as a slow, churn­ing vac­cine roll­out con­tin­ues across the globe.

A new tech­nol­o­gy out of Johns Hop­kins Uni­ver­si­ty, though, might help quick­ly and ef­fec­tive­ly test how any vac­cine — whether ap­proved for gen­er­al us­age or not — per­forms against SARS-CoV-2 or any pos­si­ble vari­ants.

Stephen Gould

Spear­head­ed by Johns Hop­kins bi­o­log­i­cal chem­istry pro­fes­sor Stephen Gould, the new tech­nol­o­gy us­es what’s called im­age-based serol­o­gy to ex­am­ine on a cel­lu­lar lev­el the spec­trum of pa­tient an­ti­bod­ies and oth­er pro­teins hu­mans make against pathogens, as well as the var­i­ous sig­nal strengths of those pro­teins.

In oth­er words, re­searchers could in the­o­ry see how the an­ti­bod­ies of some­one who’s re­ceived a Covid-19 vac­cine will re­act to cur­rent or fu­ture vari­ants of the virus, which will al­low for quick­er eval­u­a­tion of vac­cine ef­fi­ca­cy and clear­er knowl­edge of how to treat those vari­ants should a vac­cine not be ef­fec­tive.

Gould and Johns Hop­kins have grant­ed Capri­cor Ther­a­peu­tics, a Cal­i­for­nia-based biotech that spe­cial­izes in ex­o­some ther­a­pies, a non-ex­clu­sive li­cense to use the tech­nol­o­gy in two of its Covid-19 vac­cine can­di­dates. Gould is on Capri­cor’s pay­roll, but both he and Capri­cor CEO Lin­da Mar­bán were bull­ish on oth­er com­pa­nies join­ing in on the tech­nol­o­gy down the line.

In an ex­clu­sive in­ter­view with End­points News, Gould said that tech­nol­o­gy for eval­u­at­ing vac­cine ef­fi­ca­cy has been some­what lack­ing, as point-of-care as­says aren’t al­ways equipped to show the full set of an­ti­bod­ies pro­duced af­ter in­oc­u­la­tion.

“And so we’ve de­vel­oped a tech­nol­o­gy that’s de­signed to cap­ture the full ar­ray of an­ti­bod­ies,” Gould said. “And then can in­ter­ro­gate plas­mas from con­trol in­di­vid­u­als, in­fect­ed in­di­vid­u­als, and vac­ci­nat­ed in­di­vid­u­als to care­ful­ly quan­ti­fy and char­ac­ter­ize the im­mune re­spons­es, the an­ti­body re­spons­es in those pa­tients.”

The tech­nol­o­gy could play a key role go­ing for­ward, Gould ar­gued, al­low­ing re­searchers to see whether a vac­cine elic­its an­ti­bod­ies not on­ly against some forms of the spike pro­teins but against all forms.

Mar­bán said the Gould tech could be a “com­pan­ion di­ag­nos­tic” for the sec­ond-gen­er­a­tion vac­cine can­di­dates Capri­cor has de­vel­oped pre­clin­i­cal­ly, us­ing ex­o­somes to de­liv­er a mul­ti­va­lent mR­NA based Covid-19 vac­cine. The com­pa­ny hopes that the Johns Hop­kins tech­nol­o­gy will help them en­gi­neer vac­cines that pro­duce broad­er and longer-last­ing im­mu­ni­ty to any and all vari­a­tions of the virus.

“But now we al­so have this com­pan­ion di­ag­nos­tic to go along with it to pow­er the tech­nol­o­gy for­ward,” Mar­bán said. “So we’re ex­cit­ed for things to come, and look­ing for­ward to get­ting a han­dle on this pan­dem­ic and fu­ture pan­demics us­ing tests such as this.”

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

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A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

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The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

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Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

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Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

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As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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President Biden in the East Room of the White House (Evan Vucci/AP Images)

Opin­ion: How the con­fus­ing boost­er shot de­ba­cle aligns Biden with Trump's pan­dem­ic re­sponse

When President Joe Biden took office, many public health advocates heaved a sigh of relief, assuming the US was back to following the science during this once-in-a-lifetime pandemic, and gone were the days of an American president touting ineffective treatments to the world.

But this latest debacle around the Pfizer/BioNTech booster shot has now not only led to the retirements of two top FDA vaccine officials, both of whom would’ve been key resources as the US soon reviews Covid vaccines for children, but also to question marks around conflicting FDA and CDC opinions and lingering debates on who exactly should receive a boost first and who should be the one that makes that decision.