Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day af­ter Mod­er­na and the NIH pub­lished much-an­tic­i­pat­ed da­ta from their Phase I Covid-19 vac­cine tri­al, at­ten­tion is turn­ing to As­traZeneca which, ac­cord­ing to a UK re­port, is ex­pect­ed to pub­lish its own ear­ly da­ta to­mor­row.

ITV’s Robert Pe­ston re­port­ed that As­traZeneca will pub­lish the Phase I da­ta in The Lancet. 

As­traZeneca and Mod­er­na rep­re­sent the two most am­bi­tious Covid-19 vac­cine ef­forts, hav­ing set the quick­est time­lines for ap­proval (though they were re­cent­ly joined in that re­gard by the Pfiz­er-BioN­Tech part­ner­ship) and some of the lofti­est goals in to­tal dos­es. Yet there is even less known about As­traZeneca’s vac­cine’s ef­fect on hu­mans than there was about Mod­er­na’s be­fore yes­ter­day. Al­though, in a con­tro­ver­sial move, Mod­er­na re­leased some sta­tis­tics from its Phase I in May, As­traZeneca has yet to say any­thing about what it saw in its Phase I tri­al — a move con­sis­tent with the sci­en­tif­ic con­ven­tion to with­hold da­ta un­til it can be pub­lished in a peer-re­viewed jour­nal.

In­stead, so far what the world knows about the ef­fects of a vac­cine that the US, EU, UK and a sig­nif­i­cant por­tion of the de­vel­op­ing world have signed agree­ments for — bil­lions of dol­lars for bil­lions of dos­es — can be re­duced to a pri­ma­ry study and the com­ments so far from sci­en­tists at Ox­ford Uni­ver­si­ty, where the vac­cine was first de­vel­oped, and com­pa­ny ex­ec­u­tives.

Those sci­en­tists and ex­ec­u­tives have been lay­ing the case, most re­cent­ly in a lengthy Bloomberg fea­ture re­leased to­day, that when it comes to their vac­cine, peo­ple should fo­cus on the T cell re­sponse rather than an­ti­bod­ies. Al­though vac­cines work both by elic­it­ing both a T cell re­sponse and neu­tral­iz­ing an­ti­bod­ies from B cells, in­ves­ti­ga­tors gen­er­al­ly fo­cus on an­ti­bod­ies, in part be­cause they are eas­i­er to mea­sure. Mod­er­na called its Phase I a suc­cess in part be­cause tri­al sub­jects made more neu­tral­iz­ing an­ti­bod­ies than pa­tients who had been in­fect­ed with the virus.

Re­cent com­ments from As­traZeneca ap­pear de­signed to low­er any ex­pec­ta­tions that they would show sim­i­lar re­sults. “Neu­tral­iz­ing an­ti­bod­ies is one of the things you’ll look at,” As­traZeneca R&D chief Mene Pan­ga­los told Bloomberg, “but the T-cell re­sponse is go­ing to be im­por­tant.”

Pe­ston cit­ed an un­named source who told him, “Every­body is fo­cused on an­ti­bod­ies but there is a grow­ing body of ev­i­dence sug­gest­ing that the T cells’ re­sponse is im­por­tant in the de­fence against coro­n­avirus.”

Adri­an Hill

Talk of As­traZeneca and an­ti­bod­ies be­gan af­ter ear­ly crit­ics point­ed out that the an­i­mal da­ta sup­port­ing As­traZeneca’s Phase I didn’t find high lev­els of an­ti­bod­ies. In that pri­mate study, con­duct­ed at NI­AID’s Rocky Moun­tain Lab­o­ra­to­ries in Mon­tana, in­ves­ti­ga­tors in­oc­u­lat­ed six rhe­sus mon­keys with the ex­per­i­men­tal vac­cine and ex­posed them to high dos­es of SARS-CoV-2 28 days lat­er. The mon­keys showed no signs of pneu­mo­nia or dis­ease, a re­sult that Adri­an Hill, one of the two sci­en­tists who de­vel­oped the vac­cine, told Bloomberg “wasn’t promis­ing — it was fan­tas­tic.”

William Hasel­tine, a for­mer pro­fes­sor at Har­vard Med­ical School and HIV re­searcher, wrote in Forbes that the vac­cine like­ly wouldn’t be pro­tec­tive be­cause the mon­keys didn’t pro­duce high lev­els of an­ti­bod­ies. He raised the specter of peo­ple who were pro­tect­ed from de­vel­op­ing the dis­ease but still ca­pa­ble of spread­ing the in­fec­tion to oth­ers. As­traZeneca and Ox­ford sci­en­tists coun­tered that the vac­cine didn’t need to pro­duce high lev­els of an­ti­bod­ies if it pro­duced a T cell re­sponse, and that it wasn’t fair to com­pare mon­keys ex­posed to mas­sive dos­es of the virus to re­al world sce­nar­ios any­way.

Sarah Gilbert

“No one knows how strong the im­mune re­sponse needs to be to achieve pro­tec­tion in peo­ple of any age,” Sarah Gilbert, the prin­ci­pal Ox­ford sci­en­tist be­hind the vac­cine, told Bloomberg. “If we get a strong T-cell re­sponse, we don’t need such a high neu­tral­iz­ing an­ti­body titre to achieve pro­tec­tion.”

These ques­tions of just how pro­tec­tive vac­cines are, if they might in­oc­u­late some­one from dis­ease but still al­low them to spread the virus, and how long im­mu­ni­ty might last, will like­ly be de­bat­ed for months. But a much bet­ter test for the da­ta is com­ing. As­traZeneca has al­ready be­gun one Phase III tri­al in Brazil and will soon be­gin an­oth­er in the US. Mod­er­na will launch its Phase III on Ju­ly 27th. These stud­ies, con­duct­ed on tens of thou­sands of peo­ple, will ex­am­ine T cell re­sponse and an­ti­bod­ies but the more im­por­tant ques­tion will be sim­pler: Do peo­ple in­oc­u­lat­ed with the vac­cine be­come sick, or not?

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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