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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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