Kite catch­es the in­side track on the last leg of a race to the fin­ish line with No­var­tis on a CAR-T first

David Chang, Kite

The race be­tween No­var­tis $NVS and Kite $KITE to win the first FDA ap­proval of a CAR-T for can­cer is now in the fi­nal stretch, and Kite just short­ened its dis­tance to the fin­ish line.

The biotech an­nounced this morn­ing that the FDA is pro­vid­ing a pri­or­i­ty re­view for their drug KTE-C19 (axi­cab­ta­gene ciloleu­cel), which will cut the time it takes for reg­u­la­tors to com­plete their ex­am­i­na­tion from 10 months down to 6. The FDA’s PDU­FA date is No­vem­ber 29.

Kite’s big ri­val No­var­tis won a pri­or­i­ty re­view two months ago, which should pro­vide a com­fort­able lead for the first de­ci­sion on its land­mark drug. Both rep­re­sent the cut­ting edge of a new class of drug that ex­tracts cells from pa­tients and then reengi­neers them in­to an at­tack weapon tar­get­ing can­cer cells.

Both KTE-C19 and No­var­tis’ CTL019 are tapped as two of the top block­busters in the in­dus­try pipeline. They’re go­ing af­ter dif­fer­ent in­di­ca­tions on the first round, with Kite ini­tial­ly tak­ing on drug-re­sis­tant non-Hodgkin lym­phoma. But No­var­tis — tak­ing its first shot at chil­dren with acute lym­phoblas­tic leukemia — will switch fo­cus to its JULI­ET study for some head-to-head com­par­isons on dif­fuse large B-cell lym­phoma that will at­tract plen­ty of in­tense at­ten­tion, as well as spec­u­la­tion over the im­pact it will have on Kite’s stock price.

That new da­ta — which al­ready earned a spe­cial break­through ti­tle at the FDA — should ar­rive next month.

In the mean­time, reg­u­la­tors will be fol­low­ing through on re­views for two des­ig­nat­ed ‘break­through’ drugs, mak­ing it at least pos­si­ble for the two drugs to reach an ex­pert pan­el at about the same time.

Kite had man­aged to get through its reg­is­tra­tion pro­gram with­out any ex­cep­tion­al safe­ty is­sues — right un­til it was hit a few weeks ago with the death of a pa­tient due to cere­bral ede­ma. The biotech went to some pains to note just how sick this pa­tient was when he died, but its stock slid as in­vestors con­sid­ered the im­pli­ca­tions. Juno’s lead CAR-T was knocked out of the race when 5 pa­tients died of cere­bral ede­mas, or brain swelling, in­clud­ing 2 who died af­ter the FDA de­cid­ed to lift a clin­i­cal hold on the pro­gram af­ter just a few days.

Those deaths and all the safe­ty is­sues fac­ing CAR-T ther­a­pies will now get care­ful scruti­ny at the FDA.

“Pa­tients with re­frac­to­ry ag­gres­sive NHL face a dire prog­no­sis with on­ly a 50 per­cent chance of sur­viv­ing six months. This un­der­scores the ur­gent med­ical need for these pa­tients and why every day mat­ters, from de­vel­op­ment to man­u­fac­tur­ing to clin­i­cal ex­pe­ri­ence,” said David Chang, ex­ec­u­tive vice pres­i­dent of re­search and de­vel­op­ment and CMO of Kite. “We firm­ly be­lieve in the po­ten­tial for axi­cab­ta­gene ciloleu­cel to ad­dress this need and forge a new path for the fu­ture of cell ther­a­py.”

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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