$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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Jeff Baxter, VBI Vaccines CEO (ChromaDex)

VBI Vac­cines ex­ecs tout ap­proval of new triple-anti­gen he­pati­tis B shot. Can they sell it?

VBI Vaccines celebrated a new approval Wednesday morning, announcing the FDA has greenlighted its hepatitis B vaccine for adults. But questions remain on how well the new shot will sell.

The biotech intends to hit the market in the first quarter of next year, joining three other adult hepatitis B vaccines from Merck, Dynavax and GlaxoSmithKline. CEO Jeff Baxter said in an analyst call Wednesday the price of VBI’s shot, branded as PreHevbrio, won’t be revealed until commercialization, but claimed it would be “highly competitive.”