Anthony Fauci, NIAID director (AP Images)

Covid-19 roundup: Fau­ci says multi­bil­lion-dol­lar pro­gram could curb fu­ture pan­demics; Japan­ese drug­mak­er spices up coro­n­avirus pill race

When the Covid-19 pan­dem­ic swept in, drug­mak­ers were able to spin years worth of re­search in­to the fastest turn­around time for vac­cine de­vel­op­ment the world has ever seen. In an­tic­i­pa­tion of the next po­ten­tial glob­al health threat, NI­AID di­rec­tor An­tho­ny Fau­ci has been pro­mot­ing a multi­bil­lion-dol­lar plan that could cre­ate “pro­to­type vac­cines” in prepa­ra­tion of what comes next.

And if the US can find fund­ing, Fau­ci thinks that the re­search can start as ear­ly as next year.

An am­bi­tious plan that the New York Times re­ports could cost a few bil­lion dol­lars a year for at least five years would re­search and un­cov­er the mol­e­c­u­lar struc­ture of virus­es, learn where the an­ti­body must en­ter and dis­cov­er how to make the an­ti­bod­ies.

The NI­AID would be re­spon­si­ble for much of the fund­ing, the Times re­port­ed. But some of the scope would re­quire mon­ey al­lo­cat­ed by Con­gress.

In a New York­er pro­file from 2016, Fau­ci said the coun­try will have to be flex­i­ble in the fu­ture to pre­vent and fight against fu­ture pan­demics.

“I have been say­ing for eight, 10 years that we should make a list of mi­crobes and try to de­vel­op a ba­sic plat­form vac­cine,” he said. “We keep try­ing to de­vel­op a vac­cine for one thing—usu­al­ly the last one—and it’s a waste of time. Every time we get hit, it is al­ways some­thing we didn’t ex­pect. So, in­stead of pre­de­ter­min­ing what it is you’re go­ing to pre­pare for, make uni­ver­sal plat­forms.”

In the­o­ry, Fau­ci said, you could in­sert the gene of the pro­tein you want to ex­press in­to a pre-made chas­sis, cre­ate dos­es — he told Spec­tor rough­ly “a gazil­lion” — and send it to tri­als. But all this would take a new sys­tem to man­u­fac­ture vac­cines be­fore the next pan­dem­ic ar­rives. Be­cause of the hefty, mul­ti-bil­lion dol­lar price tag, politi­cians and com­pa­nies have been hes­i­tant to get the ball rolling.

Japan­ese drug­mak­er spices up race for Covid-19 pill

A once-a-day pill de­signed to pro­vide more con­ve­nient dos­ing for Covid-19 pa­tients is now be­ing test­ed in hu­man tri­als.

Sh­iono­gi, a Japan­ese com­pa­ny known for its cho­les­terol drug Crestor, said it start­ed tri­als this month, which will con­tin­ue un­til 2022. It’s an an­nounce­ment that’s added a spark to the race that al­so fea­tures Pfiz­er and Mer­ck.

Pfiz­er and Mer­ck are months ahead of Sh­iono­gi, The Wall Street Jour­nal re­port­ed. Pfiz­er said its twice-dai­ly pill could be ready to go to mar­ket this year, and will en­roll 2,000 pa­tients in a tri­al that com­bines a boost­er drug and the pill against a place­bo.

Fau­ci warns that US is head­ed in wrong di­rec­tion, rec­om­mends boost­er

A com­bi­na­tion of un­vac­ci­nat­ed Amer­i­cans and the Delta vari­ant has led a frus­trat­ed An­tho­ny Fau­ci to say the US is head­ed in the wrong di­rec­tion, he said on CNN’s show “State of the Union.”

Boost­er shots may be re­quired for those with sup­pressed im­mune sys­tems and pub­lic health of­fi­cials are con­sid­er­ing a mask rec­om­men­da­tion for those who are al­ready vac­ci­nat­ed, the As­so­ci­at­ed Press re­port­ed. More than 163 mil­lion peo­ple are vac­ci­nat­ed, but that num­ber is less than half of the US pop­u­la­tion. And 57% of those who are el­i­gi­ble for the vac­cine have been in­oc­u­lat­ed.

Amer­i­cans who are among the most vul­ner­a­ble pop­u­la­tion, such as or­gan trans­plant and can­cer pa­tients, will be most like­ly rec­om­mend­ed a boost­er.

“What I would re­al­ly like to see is more and more of the lead­ers in those ar­eas that are not vac­ci­nat­ing to get out and speak out and en­cour­age peo­ple to get vac­ci­nat­ed,” Fau­ci said.

As­traZeneca-Pfiz­er com­bo proves ef­fec­tive in South Ko­rea

A South Ko­re­an study in­volv­ing near­ly 500 med­ical work­ers showed a mixed vac­ci­na­tion of first As­traZeneca’s jab then a dose of the Pfiz­er-BioN­Tech shot boost­ed an­ti­body lev­els by at least six times, Reuters re­port­ed Mon­day.

The shots were up against a dou­ble dose of As­traZeneca in the study. Of the 499 med­ical work­ers, 100 re­ceived mixed dos­es and 200 re­ceived just the Pfiz­er-BioN­Tech jab. Last month, a study out of the UK showed sim­i­lar re­sults: An As­traZeneca shot fol­lowed by Pfiz­er showed the best T cell re­spons­es and a high­er an­ti­body re­sponse than Pfiz­er fol­lowed by As­traZeneca’s.

Vol­un­teers that re­ceived a mixed duo of dos­es showed neu­tral­iz­ing an­ti­bod­ies, which stop the virus from en­ter­ing cells. Some coun­tries are look­ing to switch to al­ter­na­tives af­ter re­ports of rare but fa­tal blood clots were linked to the As­traZeneca jab.

The study an­a­lyzed ac­tiv­i­ty against vari­ants, and saw that neu­tral­iza­tion was de­creased against the Be­ta, Gam­ma and Delta vari­ants. All three groups main­tained the same neu­tral­iz­ing ac­tiv­i­ty against the Al­pha vari­ant.

BioN­Tech CEO not call­ing for boost­er just yet

Those who re­ceived Pfiz­er and BioN­Tech’s vac­cine in Jan­u­ary are less pro­tect­ed from the Covid-19 Delta vari­ant, BioN­Tech CEO Ugur Sahin said to the Wall Street Jour­nal last week, but a boost­er shot is not called for just yet.

Ugur Sahin

Da­ta from Is­rael have emerged show­ing those who re­ceived the jab in Jan­u­ary are three times more like­ly to be­come in­fect­ed than those who were just in­oc­u­lat­ed in May. Gov­ern­ments now need to de­cide whether they want to of­fer boost­ers, or de­cide whether to let in­fec­tions go on know­ing that pa­tients will be pro­tect­ed from se­ri­ous in­jury and death, the Ger­man com­pa­ny’s CEO said.

Is­rael’s Health Min­istry pub­lished da­ta that said af­ter two shots, the vac­cine was 39% ef­fec­tive at low­er­ing risk of in­fec­tion and 40% ef­fec­tive at re­duc­ing symp­to­matic dis­ease when the Delta vari­ant made up the ma­jor­i­ty of cas­es, the WSJ said.

In April, Pfiz­er CEO Al­bert Bourla said in an in­ter­view with CN­BC that a third shot will be need­ed with­in 12 months of in­oc­u­la­tion. Sahin said that he won’t give pub­lic ad­vice on a third shot un­til da­ta from re­al-life stud­ies rolls in.

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

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

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

As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,500+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,500+ biopharma pros reading Endpoints daily — and it's free.

Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

At­tempt­ing to ride boost­er ad­comm coat­tails, Mod­er­na says its Covid-19 shot is bet­ter than Pfiz­er/BioN­Tech

As the FDA prepares to convene an adcomm to discuss Pfizer/BioNTech’s Covid-19 vaccine boosters later this week, the other major mRNA player is sticking its thumb out and trying to hitch a ride on the corporate media blitz.

Moderna put out a press release Wednesday afternoon pointing to two recently unveiled studies that, the biotech asserts, solidify the need for Covid-19 boosters, leaping into the ongoing debate for the shots. The release comes merely hours after briefing documents for the Pfizer/BioNTech adcomm went public, with Moderna putting forth an argument for why its vaccines are better suited to combat the Delta variant than Pfizer and BioNTech’s jab.