Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Some­times, be­ing late can give you an ad­van­tage.

Thomas Tri­om­phe

That’s what Sanofi and GSK are try­ing to say as the Big Phar­ma part­ners re­port pos­i­tive re­sults from a late-stage tri­al of their next-gen bi­va­lent Covid-19 vac­cine, which was de­signed to pro­tect against both the orig­i­nal strain of the SARS-CoV-2 virus and the Be­ta vari­ant. Specif­i­cal­ly, against Omi­cron, they note, the vac­cine de­liv­ered 72% ef­fi­ca­cy in all adults and 93.2% in those pre­vi­ous­ly in­fect­ed.

“With the im­muno­genic­i­ty da­ta from our Be­ta-boost­er vac­cine, they sup­port our be­lief that, in a large­ly seropos­i­tive world, a next-gen­er­a­tion Be­ta boost­er vac­cine could pro­vide pro­tec­tion against vari­ants like Omi­cron,” said Thomas Tri­om­phe, Sanofi’s EVP of vac­cines, in a state­ment. “mR­NA has proven speed to mar­ket; we are demon­strat­ing here the ef­fi­ca­cy that our re­com­bi­nant pro­tein plat­form can pro­vide to the world.”

Roger Con­nor

The com­pa­nies are hop­ing to make this can­di­date avail­able by the end of the year, added Roger Con­nor, pres­i­dent of GSK Vac­cines.

Sep­a­rate­ly, Sanofi and GSK are wrap­ping up their reg­u­la­to­ry sub­mis­sions on a Be­ta-on­ly boost­er can­di­date and, armed with da­ta un­veiled re­cent­ly, say they will stand ready to roll out a boost­er cam­paign.

In Stage 2 of the Phase III VAT08 tri­al, which en­rolled 13,000 adult par­tic­i­pants, the bi­va­lent vac­cine can­di­date demon­strat­ed an ef­fi­ca­cy of 64.7% over­all against symp­to­matic Covid-19.

The 72% ef­fi­ca­cy in Omi­cron-con­firmed symp­to­matic cas­es was cal­cu­lat­ed based on se­quenc­ing per­formed for 71 cas­es out of 121 to­tal cas­es to date.

Fur­ther­more:

In pre­vi­ous­ly seropos­i­tive pop­u­la­tions, the Sanofi-GSK vac­cine can­di­date demon­strates an over­all ef­fi­ca­cy of 75.1% (95% con­fi­dence in­ter­val [CI, 56.3, 86.6]) against symp­to­matic in­fec­tion, and 93.2% (95% con­fi­dence in­ter­val [CI, 73.2, 99.2]) in Omi­cron-con­firmed symp­to­matic cas­es, ac­cord­ing to the se­quenc­ing analy­sis per­formed to date.

Sanofi and GSK had hoped ear­ly on that a com­bi­na­tion of their pro­tein-based vac­cine and ad­ju­vant tech­nolo­gies could bring a more tra­di­tion­al, even if slight­ly slow­er, op­tion to the ta­ble. But an ear­ly set­back de­layed their ef­forts, forc­ing them to shift strate­gies to fo­cus on a world that’s al­ready flood­ed with mR­NA and ade­n­ovirus-based shots.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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