Mene Pangalos (AstraZeneca via YouTube)

Af­ter fil­ing for au­tho­riza­tion of its Covid-19 an­ti­body as a pro­phy­lac­tic, As­traZeneca pulls out new da­ta in the treat­ment set­ting

Less than a week af­ter As­traZeneca made its pitch to the FDA for emer­gency use of its mon­o­clon­al an­ti­body com­bo for Covid-19 pro­phy­lax­is, the British phar­ma is fol­low­ing up with da­ta that show the drug’s po­ten­tial as a treat­ment as well.

AZD7442 re­duced the risk of se­vere Covid-19 or death by 50% com­pared to place­bo in a group of 407 out­pa­tients who were giv­en the an­ti­body with­in sev­en days of de­vel­op­ing symp­toms, As­traZeneca re­vealed on Mon­day. That adds up to 18 events in the treat­ment arm, and 37 in the place­bo arm.

In a pre­spec­i­fied group of pa­tients who re­ceived the treat­ment with­in five days of symp­tom on­set, AZD7442 re­duced the risk of se­vere dis­ease of death by 67%, the phar­ma re­port­ed.

A to­tal of 903 pa­tients en­rolled in the Phase III TACK­LE study, span­ning Brazil, the Czech Re­pub­lic, Ger­many, Hun­gary, Italy, Japan, Mex­i­co, Poland, Rus­sia, Spain, Ukraine, the UK and the US. About 13% of par­tic­i­pants were 65 years or old­er, and 90% had co­mor­bidi­ties that put them at a high­er risk of se­vere Covid, in­clud­ing can­cer, di­a­betes, chron­ic lung dis­ease or asth­ma, obe­si­ty, car­dio­vas­cu­lar dis­ease or im­muno­sup­pres­sion.

“An ear­ly in­ter­ven­tion with our an­ti­body can give a sig­nif­i­cant re­duc­tion in pro­gres­sion to se­vere dis­ease, with con­tin­ued pro­tec­tion for more than six months,” ex­ec­u­tive VP of bio­phar­ma­ceu­ti­cals R&D Mene Pan­ga­los said in a state­ment.

As­traZeneca says it will dis­cuss the da­ta with health au­thor­i­ties, but didn’t of­fer up a time­line for an EUA sub­mis­sion in the treat­ment set­ting.

The phar­ma filed AZD7442 for au­tho­riza­tion as a pro­phy­lac­tic on Oct. 5, a month af­ter re­port­ing that the an­ti­body com­bo was 77% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 com­pared to place­bo. How­ev­er, it’s un­clear how the FDA may view the tri­al’s rel­a­tive­ly small sam­ple size. And de­spite the pos­i­tive ef­fi­ca­cy re­sults, VP and head of mi­cro­bial sci­ences and bio­phar­ma­ceu­ti­cals R&D Mark Ess­er stressed that AZD7442 is in­tend­ed for use on top of vac­ci­na­tion, not in lieu of it.

Mark Ess­er

AZD7442 was dis­cov­ered by the Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter, and li­censed to As­traZeneca last June. It’s a com­bi­na­tion of the an­ti­bod­ies tix­agevimab and cil­gav­imab, de­rived from B cells do­nat­ed by a hus­band and wife team who had re­cov­ered from Covid-19.

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

“With con­tin­ued cas­es of se­ri­ous COVID-19 in­fec­tions across the globe, there is a sig­nif­i­cant need for new ther­a­pies like AZD7442 that can be used to pro­tect vul­ner­a­ble pop­u­la­tions from get­ting COVID-19 and can al­so help pre­vent pro­gres­sion to se­vere dis­ease,” prin­ci­pal in­ves­ti­ga­tor Hugh Mont­gomery said in a state­ment on Mon­day.

It’s been over a month since fed­er­al of­fi­cials restart­ed dis­tri­b­u­tion of Eli Lil­ly’s an­ti­body com­bo  — bam­lanivimab and ete­se­vimab — which had been tak­en off the mar­ket due to a “sus­tained in­crease” of cer­tain coro­n­avirus vari­ants in the US.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.