Brii Bio joins the NIH grave­yard along­side GSK, Lil­ly af­ter flop­ping an­ti­body study in hos­pi­tal­ized Covid-19 pa­tients

Just a day af­ter Glax­o­SmithK­line and Vir Biotech­nol­o­gy’s Covid-19 an­ti­body fell flat in an NIH-spon­sored tri­al for hos­pi­tal­ized pa­tients, re­searchers have eject­ed an­oth­er ther­a­py from the study. Is this the death knell for mon­o­clon­al an­ti­bod­ies for those pa­tients?

An an­ti­body cock­tail from Brii Bio­sciences failed to show a trend to­ward clin­i­cal ben­e­fit in the NIH’s AC­TIV-3 tri­al, and as a re­sult, did not meet cri­te­ria for fur­ther en­roll­ment. As such, the NIH shut down the study sub­group eval­u­at­ing the pro­gram Thurs­day, which con­tains the two Brii an­ti­bod­ies dubbed BRII-196 and BRII-198.

Re­searchers had re­cruit­ed 343 vol­un­teers out of a goal of 450 in­to the Brii sub­group of AC­TIV-3, and they will con­tin­ue to be fol­lowed for 18 months. Pa­tients were ran­dom­ized to re­ceive ei­ther a saline place­bo or Brii’s com­bo on top of the stan­dard of care — in this case, Gilead’s Vek­lury ther­a­py, al­so known as remde­sivir.

Af­ter five days, the NIH as­sessed the par­tic­i­pants’ con­di­tions us­ing two sev­en-point scales, which de­scribed their con­di­tions rang­ing from be­ing able to un­der­take usu­al ac­tiv­i­ties with min­i­mal or no symp­toms, to death. Thurs­day’s news came af­ter a pre-planned in­ter­im analy­sis look­ing at both safe­ty and ef­fi­ca­cy.

The NIH found no safe­ty is­sues with the Brii cock­tail, and more da­ta are ex­pect­ed to be re­leased once in­ves­ti­ga­tors fin­ish an­a­lyz­ing the re­sults. The ther­a­py will con­tin­ue to be eval­u­at­ed in the AC­TIV-2 tri­al, mea­sur­ing the ef­fec­tive­ness in mild to mod­er­ate Covid-19 cas­es for those who don’t need to be hos­pi­tal­ized.

It’s a set­back for the biotech based in Chi­na and North Car­oli­na, af­ter it had part­nered with re­searchers be­hind a pa­per re­leased ear­ly in the pan­dem­ic show­ing some of the first mon­o­clon­al an­ti­body ac­tiv­i­ty against SARS-CoV-2. CEO Zhi Hong had aimed to pair their wet lab ca­pa­bil­i­ties and ac­cess to pa­tients with his biotech’s de­vel­op­ment, an­ti­body op­ti­miza­tion and reg­u­la­to­ry ex­per­tise.

Zhi Hong

But now Brii has fol­lowed the same path as Eli Lil­ly and the GSK/Vir duo, with their an­ti­body ther­a­pies strik­ing out in hos­pi­tal­ized pa­tients. Lil­ly’s an­ti­body LY-CoV555 flopped in the AC­TIV-3 pro­to­col in hos­pi­tal­ized pa­tients back in Oc­to­ber, while GSK and Vir saw their sub­group shut down af­ter in­ves­ti­ga­tors raised con­cerns about a po­ten­tial ben­e­fit, the pair said Wednes­day.

Cur­rent­ly, the on­ly in­ves­ti­ga­tion­al ther­a­py still be­ing eval­u­at­ed in the AC­TIV-3 tri­al is As­traZeneca’s AZD7442 cock­tail, which for­mer Pres­i­dent Don­ald Trump’s HHS fund­ed last Oc­to­ber for $486 mil­lion. And Vek­lury re­mains the on­ly ther­a­py specif­i­cal­ly au­tho­rized to treat pa­tients hos­pi­tal­ized with Covid-19, with the steroid dex­am­etha­sone wide­ly used in more se­vere pa­tients.  Lil­ly and Re­gen­eron have both picked up EUAs for an­ti­body ther­a­pies in non-hos­pi­tal­ized set­tings.

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection:

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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