$1.9B in: Mod­er­na blue­prints $100M fa­cil­i­ty, plans to dou­ble the pipeline af­ter a $474M megaround

Stephane Ban­cel, Mod­er­na CEO

Mod­er­na has wrapped its lat­est megaround with $474 mil­lion to in­vest in a new man­u­fac­tur­ing fa­cil­i­ty and its fast-grow­ing staff as it looks to launch new stud­ies for im­muno-on­col­o­gy and dou­ble the num­ber of ther­a­pies in the pipeline as ear­ly as next sum­mer.

Mod­er­na tipped its hand on this fundrais­ing in a Form D a few days ago. But in an in­ter­view with End­points News, Mod­er­na CEO Stephane Ban­cel spelled out where the next big in­vest­ments will be made. At the top of that to-do list is build­ing a $100 mil­lion man­u­fac­tur­ing fa­cil­i­ty, which the Cam­bridge, MA-based biotech has been scout­ing a lo­ca­tion for.

“We are re­al­ly try­ing to in­vest in the plat­form,” says Ban­cel, “to be­come the best mR­NA com­pa­ny in the world…. We are play­ing a very long game.”

Mod­er­na dis­card­ed the clas­sic biotech mold the day it start­ed in busi­ness. Rather than stake their claim to new tech­nol­o­gy by prov­ing its worth in one or two drugs, the biotech im­me­di­ate­ly set out to raise the big bucks nec­es­sary to start work on a ma­jor pipeline that could even­tu­al­ly prove its worth for a whole range of dis­eases. Pro­grams rang­ing from vac­cines to rare dis­eases, on­col­o­gy, car­dio and more are in­clud­ed. This way, says Ban­cel, a sin­gle set­back shouldn’t cloud the com­pa­ny’s fu­ture.

Clin­i­cal pro­grams were a long time com­ing as Mod­er­na built up a range of big pre­clin­i­cal part­ner­ships. But Ban­cel says the num­ber of drugs in de­vel­op­ment has swelled to 11, with the first set of da­ta slat­ed to be re­leased in 2017. Mod­er­na al­so plans to add about 10 drugs to the clin­ic by next sum­mer, says the CEO, as the 450 staffers al­ready on board are joined by 100 more be­ing re­cruit­ed now for open po­si­tions. And the new man­u­fac­tur­ing fa­cil­i­ty need­ed to sup­port its de­vel­op­ment work will be ready by the end of 2017.

They don’t get much more rev­o­lu­tion­ary than Mod­er­na, a pri­vate com­pa­ny which be­lieves its mR­NA plat­form tech can de­liv­er the nec­es­sary pack­age to spur cells to pro­duce ther­a­peu­tics, es­sen­tial­ly turn­ing bod­ies in­to drug fac­to­ries.

To get here, Mod­er­na has now raised $1.9 bil­lion from in­vestors like As­traZeneca, with an­oth­er $230 mil­lion on the ta­ble from grants. In ad­di­tion to the fi­nanc­ing an­nounce­ment this morn­ing, Mod­er­na is al­so un­veil­ing a pact to de­vel­op a new Zi­ka vac­cine, with BAR­DA putting up $8 mil­lion to get the pro­gram start­ed while of­fer­ing an op­tion on $117 mil­lion more to get through a suc­cess­ful de­vel­op­ment pro­gram.

Al­to­geth­er, this new mon­ey comes close to the record $500 mil­lion that the com­pa­ny raised last year. Even­tu­al­ly, Ban­cel says the com­pa­ny should be ready for an IPO.

“We will take the com­pa­ny pub­lic,” he tells me. “There is no doubt about it.”

First, though, Mod­er­na will have to gath­er pos­i­tive mid-stage da­ta from sev­er­al lead­ing pro­grams, leav­ing no doubt that it can achieve its dreams.

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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