Zhi Hong, Brii Biosciences CEO

An­oth­er Covid-19 an­ti­body cock­tail on the menu? Brii Bio touts ear­ly win in NIH study for a com­bo al­ready used in Chi­na

Months af­ter flop­ping in an NIH-spon­sored study, Brii Bio­sciences’ Covid-19 an­ti­body com­bo has re­deemed it­self in a sec­ond tri­al.

The biotech says its an­ti­bod­ies — which had hailed from Bei­jing’s Ts­inghua Uni­ver­si­ty and Shen­zhen Third Peo­ple’s Hos­pi­tal — dra­mat­i­cal­ly im­proved pa­tients’ odds of get­ting hos­pi­tal­ized or dy­ing over place­bo, notch­ing a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 78%. That trans­lates to a risk ra­tio of 0.22 (95% con­fi­dence in­ter­val: 0.05, 0.86; p<.00001).

Specif­i­cal­ly, when in­ves­ti­ga­tors did a par­tial fol­lowup on the 837 non-hos­pi­tal­ized pa­tients en­rolled in this arm of AC­TIV-2 tri­al at an in­ter­im analy­sis, they found:

[A] re­duc­tion in both hos­pi­tal­iza­tions 12 (ac­tive) vs 45 (place­bo) and deaths 1 (ac­tive) vs 9 (place­bo), was ob­served. Ad­di­tion­al sub­group analy­sis may fur­ther de­lin­eate the clin­i­cal ben­e­fits of ear­ly (≤5 days) ver­sus late (6-10 days) treat­ment with BRII-196/BRII-198 fol­low­ing symp­tom on­set, pro­vid­ing unique in­sight to in­form re­al-world treat­ment de­ci­sions.

The find­ings fit right with da­ta on oth­er an­ti­body cock­tails di­rect­ed against Covid-19. From Eli Lil­ly and Re­gen­eron to Glax­o­SmithK­line/Vir, an­ti­bod­ies have ap­peared much more ef­fec­tive when they’re de­ployed ear­ly. Once pa­tients are hos­pi­tal­ized, the an­ti­bod­ies tend not to help — with Re­gen­eron be­ing the on­ly ex­cep­tion, show­ing that its cock­tail could re­duce death for a sub­group of par­tic­u­lar­ly vul­ner­a­ble hos­pi­tal­ized pa­tients.

So it was lit­tle sur­prise when Brii, too, failed to show a trend to­ward clin­i­cal ben­e­fit among hos­pi­tal­ized pa­tients in the NIH’s AC­TIV-3 tri­al. As such, the NIH shut down the study sub­group eval­u­at­ing the pro­gram and halt­ed en­roll­ment ear­ly.

In AC­TIV-2, the op­po­site hap­pened: The da­ta safe­ty mon­i­tor­ing board sanc­tioned re­leas­ing the re­sults ear­ly af­ter re­view­ing around 69% of tri­al par­tic­i­pants on the com­bined pri­ma­ry end­point of hos­pi­tal­iza­tions and death.

On the safe­ty front, Brii not­ed that the BRII196/BRII-198 arm ac­tu­al­ly saw few­er Grade 3 or high­er ad­verse events than the place­bo co­hort in the 28 days fol­low­ing treat­ment (3.8% ver­sus 13.4%). No drug-re­lat­ed se­ri­ous side ef­fects, in­fu­sion re­ac­tions or deaths were ob­served in ei­ther arm.

Pa­tients from the US, Brazil, South Africa, Mex­i­co, Ar­genti­na and the Philip­pines were en­rolled in the tri­al be­tween Jan­u­ary and Ju­ly of 2021.

“In re­sponse to the re­cent emer­gence of COVID-19 cas­es in Chi­na, in­clud­ing cas­es caused by the Delta vari­ant, Brii Bio­sciences has co­op­er­at­ed with gov­ern­men­tal agen­cies and hos­pi­tals in Chi­na to sup­ply BRII-196/BRII-198 for emer­gency clin­i­cal use in Guangzhou, Shen­zhen, Ruili, Kun­ming, Nan­jing, Yangzhou, Zhangji­a­jie and Zhengzhou,” the com­pa­ny, which re­cent­ly got list­ed on the Hong Kong stock ex­change fol­low­ing a $320 mil­lion IPO raise, added in a state­ment.

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.

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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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.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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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.