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.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.