Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikun­gun­ya virus met its match in Val­ne­va’s vac­cine can­di­date, VLA1553, ac­cord­ing to da­ta from an an­ti­body per­sis­tence tri­al re­leased to­day.

The tri­al found that 99% of 363 par­tic­i­pants re­tained neu­tral­iz­ing an­ti­bod­ies 12 months af­ter a sin­gle dose of vac­cine in the com­pa­ny’s ear­li­er, larg­er Phase III tri­al, called VLA1553-301. The par­tic­i­pants from the long-term study will con­tin­ue to be mon­i­tored for at least five years.

Val­ne­va plans to fi­nal­ize its BLA sub­mis­sion with the FDA by the end of this year. The pro­gram re­ceived FDA fast track and break­through ther­a­py des­ig­na­tions in 2018 and 2021. The larg­er Phase III study, VLA1553-301, in March showed that the vac­cine gen­er­at­ed a serore­sponse rate of 96% six months af­ter vac­ci­na­tion.

If the vac­cine is ap­proved, the com­pa­ny will be first in­to a glob­al mar­ket for vac­cines against chikun­gun­ya that could ex­ceed $500 mil­lion an­nu­al­ly by 2032, ac­cord­ing to an es­ti­mate cit­ed by Val­ne­va from VacZine An­a­lyt­ics, a mar­ket re­search firm.

Val­ne­va has al­ready signed with the In­sti­tu­to Bu­tan­tan in Brazil for the de­vel­op­ment, man­u­fac­tur­ing and mar­ket­ing of VLA1553 to make it more ac­ces­si­ble for low- and mid­dle-in­come coun­tries. And in No­vem­ber, the com­pa­ny hired GSK vet­er­an Di­pal Pa­tel to be its chief com­mer­cial of­fi­cer and help with a po­ten­tial launch.

Val­ne­va is the first com­pa­ny to bring a chikun­gun­ya vac­cine in­to Phase III de­spite decades of ef­forts fo­cus­ing on the trop­i­cal dis­ease. Chikun­gun­ya, car­ried by mos­qui­toes, is a vi­ral dis­ease caused by the virus of the same name. It can cause fever, joint and mus­cle pain, headache, nau­sea, rash and chron­ic arthral­gia. It of­ten caus­es sud­den large out­breaks, es­pe­cial­ly in the Amer­i­c­as. As of Sep­tem­ber 2020, there were more than three mil­lion re­port­ed cas­es in the Amer­i­c­as and it has spread to over 100 coun­tries.

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

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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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