Passive vaccination? AstraZeneca spotlights six-month protection with Covid-19 antibody among vulnerable group

Mene Pangalos (AstraZeneca via YouTube)

New fol­low-up da­ta sug­gest that As­traZeneca’s long-act­ing an­ti­body can pro­tect high-risk pop­u­la­tions from con­tract­ing Covid-19 for as long as six months, beef­ing up the case for it as a form of ‘pas­sive im­mu­niza­tion’ or ‘pas­sive vac­ci­na­tion.’

At a six-month cut­off for the Phase III PROVENT tri­al, in­ves­ti­ga­tors tracked an 83% re­duc­tion in risk of symp­to­matic Covid-19 af­ter one dose of the an­ti­body among 4,991 vol­un­teers. The com­pa­ny did not spell out case counts on ei­ther arm, not­ing on­ly that there were no se­vere dis­ease or Covid-re­lat­ed deaths in the AZD7442 arm and two ad­di­tion­al cas­es of se­vere Covid-19 in the place­bo arm (for a to­tal of five se­vere cas­es and two re­lat­ed deaths).

Com­ing al­most two months af­ter the ini­tial read­out, the up­date was re­leased along­side a new analy­sis of the TACK­LE tri­al, which test­ed AZD7442 as a treat­ment and showed that, when giv­en with­in three days of symp­tom on­set, it can cut the risk of se­vere dis­ease or death by 88% — a sig­nif­i­cant leap from the pre­vi­ous­ly re­port­ed 50% num­ber when treat­ment was giv­en with­in sev­en days.

To­geth­er, As­traZeneca said, they paint a fuller pic­ture of AZD7442, which it had first li­censed from Van­der­bilt, as an im­por­tant ad­di­tion to the ar­se­nal.

‘AZD7442 is the on­ly long-act­ing an­ti­body with Phase III da­ta to demon­strate ben­e­fit in both pre-ex­po­sure pro­phy­lax­is and treat­ment of COVID-19 with one dose,’ said Mene Pan­ga­los, EVP of bio­phar­ma R&D in a state­ment.

In a re­cent in­ter­view with End­points News, Pan­ga­los em­pha­sized how the drug’s long-act­ing prop­er­ty sets it apart from oth­er an­ti­bod­ies. Eli Lil­ly, Re­gen­eron and Vir/Glax­o­SmithK­line have all nabbed emer­gency use au­tho­riza­tions for their ther­a­pies, with an uptick in use amid new surges due to the Delta vari­ant and break­through cas­es.

‘Oth­ers are talk­ing about pro­phy­lax­is, but they’re talk­ing about month­ly ad­min­is­tra­tion,’ he said. ‘We’re talk­ing about, po­ten­tial­ly, at a max­i­mum twice a year, I’m hop­ing it’ll be once a year. And so al­most in a way be, you know, pas­sive im­mu­niza­tion or pas­sive vac­ci­na­tion.’

The FDA is cur­rent­ly re­view­ing an EUA fil­ing in the pro­phy­lac­tic set­ting.

It’s es­pe­cial­ly rel­e­vant when you con­sid­er that PROVENT sought to en­roll par­tic­i­pants who are im­muno­com­pro­mised — peo­ple with mul­ti­ple scle­ro­sis, say, or can­cer. These peo­ple, es­ti­mat­ed to make up about 2 to 3% of the pop­u­la­tion, are thought to be less pro­tect­ed by vac­ci­na­tion.

‘Im­por­tant­ly, six months of pro­tec­tion was main­tained de­spite the surge of the Delta vari­ant among these high-risk par­tic­i­pants who may not re­spond ad­e­quate­ly to vac­ci­na­tion,’ said Hugh Mont­gomery, prin­ci­pal in­ves­ti­ga­tor and pro­fes­sor of in­ten­sive care med­i­cine at Uni­ver­si­ty Col­lege Lon­don.

On the treat­ment side, TACK­LE sim­i­lar­ly tar­get­ed pa­tients at high risk of pro­gres­sion to se­vere Covid-19 for en­roll­ment — with 90% of par­tic­i­pants in that cat­e­go­ry. Again, there was no break­down on the num­ber of cas­es in each group.

The new, ex­plorato­ry analy­sis sug­gest­ed that when giv­en soon­er af­ter symp­tom on­set, a sin­gle dose of AZD7442 could bet­ter pre­vent those se­vere out­comes much bet­ter than place­bo among non-hos­pi­tal­ized pa­tients. ‘You could treat with an oral an­tivi­ral, that’s great,’ Pan­ga­los said. ‘Now, you could treat with an an­ti­body, or you could treat with ours down the road as well, and you won’t just be treat­ed for the two weeks that you’ve got the symp­toms. You’ll be treat­ed the next 12 months in terms of pre­ven­tion.’

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

For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.

Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)

Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.

This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.

Unlock this story instantly and join 123,500+ biopharma pros reading Endpoints daily — and it’s free.

Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.

The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.

Unlock this story instantly and join 123,500+ biopharma pros reading Endpoints daily — and it’s free.

Protein degradation is one of the hot drug classes of the future, but competitors are piling in with the likes of C4, Arvinas, Frontier Medicines and Vividion jostling for position. A new startup wants to apply the lessons learned from degradation outside the cell, and it now has the greenlight from RA Capital to steam ahead.

Avilar Therapeutics launched Thursday with $60 million from founding investor RA to chase a novel protein degradation drug class the startup is calling ATACs— short for ‘ASGPR Targeting Chimeras’ — that looks to trash unwanted proteins circulating outside the human cell.

Merck is making room for yet another use on its Keytruda label — this time, as the first adjuvant immunotherapy for certain renal cell carcinoma patients after they’ve had kidney surgery.

The FDA has approved Keytruda in the adjuvant setting three weeks before its goal date, marking the latest in a streak of label expansions and giving the PD-1 superstar a leg up on its checkpoint inhibitor rivals.

Generate co-founder Molly Gibson and CEO Mike Nally

As the future of machine learning and AI promises to make major breakthroughs in drug development, a suite of startups is looking to scale their own competing robot brain trusts. An ambitious startup out of Flagship Pioneering’s incubator uncloaked last year with its own spin in that arms race — and now it’s primed and ready for a major expansion in the coming years.

Generate Biomedicines has closed a giant $370 million Series B from founding investor Flagship as well as Alaska Permanent Fund, Altitude Life Science Ventures, ARCH Venture Partners, and funds and accounts advised by T. Rowe Price Associates, the company said.

Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO

A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.

Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.

Unlock this story instantly and join 123,500+ biopharma pros reading Endpoints daily — and it’s free.

A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.

CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.

Unlock this article along with other benefits by subscribing to one of our paid plans.

The US Securities and Exchange Commission has launched a probe into claims that Cassava Sciences, an Austin-based drug developer, manipulated data key to its case for its experimental Alzheimer’s drug simufilam, the Wall Street Journal reported Wednesday.

The report comes just two days after Cassava in an SEC filing revealed that ‘certain government agencies’ had asked the biotech for documentation. It wasn’t clear which agencies were inquiring or what information they sought, and Cassava went out of its way to say the requests weren’t accusations of wrongdoing.

Unlock this story instantly and join 123,500+ biopharma pros reading Endpoints daily — and it’s free.
https://endpts.com/passive-vaccination-astrazeneca-spotlights-six-month-protection-with-covid-19-antibody-among-vulnerable-group/