Stanley Erck, Novavax CEO (Lee Jin-wook/Yonhap via AP Images)

No­vavax says its vac­cine is 80% ef­fec­tive in teens, but man­u­fac­tur­ing ques­tions con­tin­ue to cloud fu­ture

No­vavax fi­nal­ly sub­mit­ted an ap­pli­ca­tion for emer­gency use au­tho­riza­tion for its Covid-19 vac­cine late last month. Now a sec­ond ap­pli­ca­tion may al­ready be in the off­ing.

The oft-de­layed but nev­er-bor­ing Mary­land-based vac­cine com­pa­ny an­nounced pos­i­tive re­sults from its ado­les­cent tri­al on Thurs­day. The biotech’s vac­cine, known as Nu­vax­ovid, was 80% ef­fec­tive at pre­vent­ing symp­to­matic dis­ease in pa­tients 12 to 17 years old.

The 2,247-per­son tri­al was con­duct­ed while the Delta vari­ant — sig­nif­i­cant­ly more in­fec­tious and slight­ly eva­sive to im­mune re­spons­es against the orig­i­nal virus — was dom­i­nant in the US. The com­pa­ny said it se­quenced 11 out of 20 con­firmed Covid-19 cas­es in the tri­al; all were Delta.

The vol­un­teers al­so showed about 50% more neu­tral­iz­ing an­ti­bod­ies as adults had in pre­vi­ous tri­als, meet­ing an FDA re­quire­ment for non-in­fe­ri­or­i­ty.

The new da­ta raise the prospect that a third vac­cine could be­come avail­able for teenagers in the US and oth­er parts of the world, join­ing the mR­NA shots from Pfiz­er and Mod­er­na. Al­though those dos­es have been avail­able for months in the US, vac­ci­na­tion rates for teenagers re­main low rel­a­tive to adults: Just 57% of Amer­i­cans be­tween 12 and 17 have re­ceived at least 2 dos­es, ac­cord­ing to the New York Times track­er, com­pared with 71% of 18 to 65 year-olds and 89% of those over 65.

No­vavax has long ar­gued its pro­tein-based shot could be more at­trac­tive for some peo­ple, par­tic­u­lar­ly the vac­cine-hes­i­tant, than mR­NA shots: Its tech­nol­o­gy is old­er and used in oth­er shots, they note, and it has a low­er side ef­fect pro­file.

Sil­via Tay­lor

Those same fac­tors, they ar­gued, could make Nu­vax­ovid an at­trac­tive op­tion in help­ing vac­ci­nate teens, al­though it’s not clear whether the shot is suf­fi­cient­ly less re­ac­to­genic than mR­NA to boost up­take.

Around half of the vac­ci­nat­ed vol­un­teers each re­port­ed mus­cle pain, fa­tigue and headache. In Mod­er­na’s ado­les­cent tri­al, by con­trast, those symp­toms each ap­peared in about 70% of vac­ci­nat­ed par­tic­i­pants. (No­vavax did not re­lease pre­cise break­downs, opt­ing for a graph in­stead.)

”We be­lieve that our ef­fi­ca­cy and safe­ty pro­file will make us a de­sir­able op­tion in the pe­di­atric pop­u­la­tion,” Sil­via Tay­lor, No­vavax’s VP of cor­po­rate af­fairs, told re­porters Thurs­day.

No­vavax safe­ty da­ta

Click on the im­age to see the full-sized ver­sion

No­vavax has al­so made large com­mit­ments to dis­trib­ut­ing its vac­cine around the world at a time when vac­cine ac­cess is still in­equitable.

But the com­pa­ny’s plans for kids will face the same hur­dles as the com­pa­ny’s plans have faced in adults.

For one, the Omi­cron vari­ant has made its shot sig­nif­i­cant­ly less ef­fec­tive, al­though like its mR­NA ri­vals, the com­pa­ny has shown that a boost­er shot at least tem­porar­i­ly re­coups much of the lost ac­tiv­i­ty. And the com­pa­ny showed da­ta Thurs­day that an­ti­bod­ies teenagers de­vel­oped from the shot were able to neu­tral­ize Omi­cron, al­beit at re­duced po­ten­cies.

And then there’s man­u­fac­tur­ing: The com­pa­ny strug­gled for near­ly a year and a half to re­li­ably pro­duce its shot at scale, al­though there are signs those is­sues are fi­nal­ly abat­ing. The vac­cine is now au­tho­rized by the WHO and Eu­ro­pean reg­u­la­tors and is al­so en­ter­ing use in the UK, In­done­sia, In­dia and oth­er parts of the globe.

Al­though the FDA has yet to is­sue a de­ci­sion on No­vavax’s shot, the com­pa­ny’s choice to sub­mit an EUA sug­gests it be­lieves that the man­u­fac­tur­ing is­sues that re­peat­ed­ly de­layed au­tho­riza­tion have been re­solved.

Nev­er­the­less, Reuters re­port­ed this week that No­vavax has de­layed ship­ments to Eu­rope and oth­er parts of the globe. The Philip­pines, for ex­am­ple, said it has not re­ceived a sin­gle one of the 30 mil­lion shots it or­dered and was now con­sid­er­ing rene­go­ti­at­ing its con­tract.

Asked about the de­lays, Tay­lor on­ly ad­dressed the sit­u­a­tion in Eu­rope — where she said EU ship­ments have to un­der­go lo­cal test­ing in the Nether­lands be­fore be­ing dis­trib­uted to lo­cal coun­tries — but didn’t ad­dress de­lays else­where. She al­so re­it­er­at­ed the com­pa­ny will have the ca­pac­i­ty to pro­duce 2 bil­lion dos­es an­nu­al­ly, a goal No­vavax has been promis­ing since 2020. As re­cent­ly as last April, they said they would reach the ca­pac­i­ty by Q3 2021.

Tay­lor, though, de­clined to say how many dos­es the com­pa­ny is pro­duc­ing at the mo­ment — on­ly that they would meet their promis­es.

“We have com­mit­ments in place for 2 bil­lion dos­es,” she said. “That is a good match, we can make as much as we need to sup­ply our dose com­mit­ments.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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