Covid-19 roundup: Abi­vax pulls the plug on its an­ti-in­flam­ma­to­ry treat­ment; J&J says it could fall short on Q2 vac­cine sup­ply for EU — re­port

An­oth­er Covid-19 treat­ment is bit­ing the dust af­ter an in­de­pen­dent Da­ta Safe­ty and Mon­i­tor­ing Board flagged it for lack of ef­fi­ca­cy.

Paris-based Abi­vax shared last week that it’s slam­ming the brakes on its Phase IIb/III clin­i­cal tri­al for ABX464 in high-risk Covid pa­tients. The study, dubbed miR-AGE, had al­ready re­cruit­ed 500 pa­tients of the planned 1,034.

Re­searchers were test­ing the an­ti-in­flam­ma­to­ry to see if it could pre­vent se­vere dis­ease. But a planned in­ter­im analy­sis of da­ta from 306 pa­tients showed no dif­fer­ence be­tween the drug and a place­bo. ABX464 was well-tol­er­at­ed and safe, Abi­vax not­ed.

The re­sults came as a shock to some re­searchers, in­clud­ing Jorge Kalil, a pro­fes­sor at the Uni­ver­si­ty Hos­pi­tal Cen­ter in São Paulo and na­tion­al co­or­di­na­tor of the miR-AGE study in Brazil.

“As an im­mu­nol­o­gist, I am puz­zled by the out­come of the in­ter­im analy­sis, as ABX464 ad­dress­es both the vi­ral and in­flam­ma­to­ry as­pects of the dis­ease,” Kalil said in a state­ment. “How­ev­er, we rec­og­nize that Covid-19 is a nov­el, hy­per-acute and com­plex dis­ease that in­volves var­i­ous vi­ral and in­flam­ma­to­ry path­ways, plus the co­ag­u­la­tion sys­tem, which are still not ful­ly un­der­stood.”

While Abi­vax CEO Hart­mut Ehrlich called the find­ings “dis­ap­point­ing,” he em­pha­sized that ABX464 has shown pos­i­tive da­ta in ul­cer­a­tive col­i­tis, where it was al­ready be­ing test­ed be­fore en­ter­ing the Covid study.

ABX464 isn’t the on­ly po­ten­tial Covid-19 treat­ment can­di­date to come up short. Just last week, the UK’s RE­COV­ERY tri­al halt­ed en­roll­ment in its colchicine study af­ter a da­ta mon­i­tor­ing com­mit­tee saw “no con­vinc­ing ev­i­dence that fur­ther re­cruit­ment would pro­vide con­clu­sive proof of worth­while mor­tal­i­ty ben­e­fit ei­ther over­all or in any pre-spec­i­fied sub­group.”

J&J says it could fall short on Q2 vac­cine sup­ply for EU re­port

The EU could soon be fac­ing more vac­cine dis­tri­b­u­tion woes, as John­son and John­son wor­ries it won’t be able to meet its Q2 quo­ta.

J&J told the EU that it was “un­der stress” to meet its goal of 55 mil­lion dos­es by the end of June, an un­named EU of­fi­cial told Reuters. The com­pa­ny cit­ed is­sues with the sup­ply of in­gre­di­ents and equip­ment, ac­cord­ing to the of­fi­cial.

The sin­gle-dose vac­cine has al­ready been au­tho­rized by the FDA, and is ex­pect­ed to get the OK for use in the EU on March 11. J&J is on the hook for 200 mil­lion dos­es to the bloc this year, and de­liv­er­ies are ex­pect­ed to start as ear­ly as April, Reuters re­port­ed.

Fail­ing to meet the Q2 goal could spell out a headache for the EU, which has al­ready been deal­ing with dis­tri­b­u­tion lags. Italy threat­ened to take le­gal ac­tion back in Jan­u­ary, al­leg­ing that de­liv­er­ies of the Pfiz­er/BioN­Tech vac­cine were un­ex­pect­ed­ly cut. Ger­many’s Ham­burg al­so re­port­ed re­ceiv­ing a small­er ship­ment. And last week, Italy and the EU blocked a 250,000-dose ship­ment of As­traZeneca’s vac­cine to Aus­tralia to pro­tect its own sup­ply.

Ten­sions rise be­tween EMA and Russ­ian vac­cine de­vel­op­er

Af­ter the head of the EMA’s man­age­ment board ad­vised EU coun­tries to hold off on au­tho­riz­ing Rus­sia’s Sput­nik V vac­cine, the shot’s de­vel­op­ers want an apol­o­gy.

“We de­mand a pub­lic apol­o­gy from EMA’s Christa Wirthumer-Hoche for her neg­a­tive com­ments on EU states di­rect­ly ap­prov­ing Sput­nik V,” a post from the of­fi­cial Sput­nik V Twit­ter ac­count reads. “Her com­ments raise se­ri­ous ques­tions about pos­si­ble po­lit­i­cal in­ter­fer­ence in the on­go­ing EMA re­view.”

Wirthumer-Hoche said dur­ing a talk show on Sun­day that the EU should wait to au­tho­rize the vac­cine while the EMA re­views its safe­ty and ef­fi­ca­cy, ac­cord­ing to a Reuters re­port.

While the vac­cine has been met with much skep­ti­cism, a Lancet study pub­lished last month sug­gests Sput­nik V has an ef­fi­ca­cy rate of 91.6%. The re­sults came from a 20,000-per­son Phase III tri­al, and ef­fi­ca­cy rate was based on the num­ber of Covid-19 cas­es tracked 21 days af­ter the first dose was ad­min­is­tered. Sput­nik V’s pro­tec­tion ap­plied to all age groups, in­clud­ing those old­er than 60, the Lancet re­sults said. No se­ri­ous ad­verse events re­lat­ed to the vac­cine were not­ed, though 45 pa­tients in the vac­cine group ex­pe­ri­enced se­ri­ous side ef­fects un­re­lat­ed to the vac­cine, ac­cord­ing to the Gama­leya Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy.

Rus­sia reg­is­tered the vac­cine back in Au­gust — and Pres­i­dent Vladimir Putin says his daugh­ter took it — well be­fore Phase III stud­ies were com­plet­ed. The move spurred much back­lash, in­clud­ing from the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions, which wrote a let­ter urg­ing Russ­ian health min­is­ter Mikhail Murashko not to give out an un­proven vac­cine.

“EMA did not al­low such state­ments about any oth­er vac­cine. Such com­ments are in­ap­pro­pri­ate and un­der­mine cred­i­bil­i­ty of EMA and its re­view process,” the Sput­nik V ac­count tweet­ed. “Vac­cines and EMA should be above and be­yond pol­i­tics.”

Pfiz­er/BioN­Tech vac­cine neu­tral­izes vari­ant spread­ing in Brazil — study

In a test to see how Pfiz­er and BioN­Tech’s vac­cine fares against new vari­ants emerg­ing around the world, the jab was able to neu­tral­ize the P.1 vari­ant, which was first de­tect­ed in Brazil, ac­cord­ing to a let­ter to the ed­i­tor of the New Eng­land Jour­nal of Med­i­cine. 

The jab al­so neu­tral­ized vari­ants first de­tect­ed in the UK (B.1.1.7-spike) and South Africa (B.1.351-spike), and two sub­sets of mu­ta­tions de­rived from B.1.351 lin­eage. But com­pared to an ear­ly iso­late of the virus, neu­tral­iza­tion of the South Africa vari­ant was weak­er by about two-thirds.

From the let­ter:

Our da­ta are al­so con­sis­tent with poor­er neu­tral­iza­tion of the virus with the full set of B.1.351- spike mu­ta­tions than virus with ei­ther sub­set of mu­ta­tions and sug­gest­ed that virus with mu­tant residues in the re­cep­tor-bind­ing site (K417N, E484K, and N501Y) is more poor­ly neu­tral­ized than virus with Δ242-244, which is lo­cat­ed in the N-ter­mi­nal do­main of the spike pro­tein.

Geo­met­ric mean neu­tral­iz­ing titers against the UK and Brazil vari­ants were “rough­ly equiv­a­lent” to those pro­duced against the ear­ly iso­late, while titers against the South African vari­ant were “ro­bust but low­er,” the au­thors from the Uni­ver­si­ty of Texas Med­ical Branch wrote.

Pri­or stud­ies have sug­gest­ed that Pfiz­er and BioN­Tech’s vac­cine can pro­tect against vari­ants spread­ing in the UK and South Africa, though may be less po­tent against the South Africa vari­ant. The com­pa­nies are test­ing boost­er op­tions, in­clud­ing a third dose of the cur­rent vac­cine and a new for­mu­la­tion that specif­i­cal­ly tar­gets the vari­ant.

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

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.