UP­DAT­ED: As­traZeneca says mon­o­clon­al an­ti­body com­bo is 77% ef­fec­tive at pre­vent­ing Covid-19

Af­ter hit­ting just about every pot­hole with its Covid-19 vac­cine roll­out, As­traZeneca has some good news to share for an­oth­er pan­dem­ic-re­lat­ed pro­gram: Its mon­o­clon­al an­ti­body com­bo, AZD7442, proved ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 in a Phase III study.

AZD7442 re­duced the risk of symp­to­matic Covid-19 by 77%, based on a pre­lim­i­nary group of cas­es in a large, glob­al Phase III tri­al, ac­cord­ing to the British phar­ma. The study, dubbed PROVENT, en­rolled near­ly 5,200 vol­un­teers across the US, UK, Spain, France and Bel­gium, 75% of whom had co­mor­bidi­ties or con­di­tions that would cause a re­duced im­mune re­sponse to vac­ci­na­tion.

“We in­ten­tion­al­ly re­cruit­ed peo­ple at high risk or an in­creased risk for an in­ad­e­quate re­sponse to vac­ci­na­tion, or hav­ing a se­vere SARS-CoV-2 in­fec­tion,” Mark Ess­er, VP of mi­cro­bial sci­ences and bio­phar­ma­ceu­ti­cals R&D, told re­porters in a press con­fer­ence on Fri­day morn­ing.

Of 25 re­port­ed Covid-19 cas­es at the pre­lim­i­nary read­out, there were no se­vere cas­es or deaths in the treat­ment arm, and three se­vere cas­es and two deaths in the place­bo arm.

That’s all the ef­fi­ca­cy da­ta As­traZeneca is shar­ing for now, though the com­pa­ny says it’s run­ning the re­sults to reg­u­la­tors in pur­suit of an emer­gency use au­tho­riza­tion or con­di­tion­al ap­proval for the pre­ven­tion of Covid-19.

“We don’t nor­mal­ly talk about sub­mis­sion time­lines. The team is be­ing pushed very hard to try and get a sub­mis­sion in with­in, you know, I would say a few weeks,” EVP of bio­phar­ma­ceu­ti­cals R&D Mene Pan­ga­los said dur­ing the call. “I think it’s not un­re­al­is­tic to hope that we might get an ap­proval be­fore the end of the year,” he added.

While the read­out looks at da­ta col­lect­ed be­fore the Delta vari­ant gained promi­nence across the globe, As­traZeneca says it has pre­lim­i­nary in vit­ro da­ta sug­gest­ing the AZD7442 neu­tral­izes emerg­ing vari­ants, in­clud­ing Delta. Ad­verse events were bal­anced be­tween the place­bo and treat­ment groups, ac­cord­ing to Pan­ga­los.

“There’s noth­ing that’s stand­ing out in terms of ad­verse events,” he said.

The phar­ma is eval­u­at­ing AZD7442 in a va­ri­ety of set­tings. The can­di­date — dis­cov­ered by the Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter and li­censed to As­traZeneca last June — is a com­bi­na­tion of the an­ti­bod­ies tix­agevimab and cil­gav­imab, de­rived from B cells do­nat­ed by re­cov­ered Covid-19 pa­tients.

In ad­di­tion to the PROVENT, AZD7442 is al­so in the on­go­ing TACK­LE COVID-19 pro­gram, which looks at the an­ti­bod­ies’ abil­i­ty to treat and pre­vent Covid across more than 9,000 par­tic­i­pants in the out­pa­tient set­ting. And while vol­un­teers got the can­di­date in­ject­ed in­to the mus­cle in PROVENT, it’s al­so be­ing as­sessed as an IV drug.

Back in June, AZD7442 missed the mark in a study as­sess­ing its abil­i­ty to pre­vent symp­toms in adults who had a con­firmed ex­po­sure to Covid-19. As­traZeneca says the an­ti­body com­bo per­formed bet­ter in a pre-planned analy­sis of PCR-neg­a­tive vol­un­teers.

Pro­phy­lac­tic treat­ments like AZD7442 could prove use­ful for those with weak­er im­mune sys­tems, or those who don’t re­spond well to a vac­cine. That in­cludes pa­tients who are on chemother­a­py, have blood can­cers, or are tak­ing im­muno­sup­pres­sants, among oth­ers. And as the rise of con­cern­ing vari­ants ren­ders pre­vi­ous­ly au­tho­rized treat­ments in­ef­fec­tive, the US is look­ing for any­thing it can get to stave off se­vere cas­es.

Mene Pan­ga­los

The fed­er­al gov­ern­ment struck a deal with As­traZeneca back in March for an ex­tra half-mil­lion dos­es of AZD7442, build­ing on its ex­ist­ing 100,000-dose or­der from Oc­to­ber. The com­pa­ny al­so has a sep­a­rate agree­ment with the De­part­ment of De­fense for 100,000 dos­es, bring­ing its to­tal com­mit­ment to the US up to 700,000 dos­es in 2021.

While no vol­un­teers in PROVENT had been vac­ci­nat­ed be­fore join­ing the study, As­traZeneca says it sees AZD7442 as a sup­ple­ment to the cur­rent­ly ap­proved vac­cines. While it can be tak­en alone, the re­al­i­ty is a ma­jor­i­ty of peo­ple will like­ly use it in ad­di­tion to a vac­cine, Pan­ga­los said. Over the course of the study, more than 400 peo­ple in the treat­ment arm de­cid­ed to opt out and get vac­ci­nat­ed, and re­searchers have seen “no is­sues there,” ac­cord­ing to Ess­er.

“We’ve done pre­clin­i­cal stud­ies in non-hu­man pri­mates or mon­keys to show that the an­ti­body doesn’t in­ter­fere with vac­ci­na­tion, and we hope to pub­lish that short­ly,” he added.

The com­pa­ny de­clined to com­ment on how much the treat­ment might cost, if even­tu­al­ly au­tho­rized by reg­u­la­tors.

The news comes a cou­ple months af­ter the US paused the use of Eli Lil­ly’s an­ti­body com­bo, urg­ing care­givers to opt for Re­gen­eron’s cock­tail as an al­ter­na­tive be­cause it’s more ef­fec­tive against the vari­ants.

As­traZeneca’s cel­e­brat­ing the good news af­ter a rocky vac­cine roll­out, in­clud­ing a le­gal bat­tle over ship­ment de­lays in the EU and re­ports of rare blood clots in those who re­ceived the vac­cine.

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

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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