Boom­ing Mod­er­na is rais­ing $600M while ramp­ing up man­u­fac­tur­ing and clin­i­cal stud­ies

Ever since Flag­ship launched Mod­er­na back in 2012 with a $40 mil­lion round, the biotech has been a per­pet­u­al mon­ey-rais­ing ma­chine, gar­ner­ing well over a bil­lion dol­lars from an avid group of in­vestors and part­ners look­ing to par­tic­i­pate in its promised drug R&D rev­o­lu­tion. And now in a fil­ing with the SEC, the com­pa­ny has out­lined its lat­est big ef­fort to add $600 mil­lion to its cof­fers, with most of the cash al­ready in hand.

Stephane Ban­cel, Mod­er­na CEO

Ac­cord­ing to the fil­ing, Mod­er­na has raised $451,369,079, with $148,630,019 to go. The Form D was filed last week. The mon­ey marks a new record for Mod­er­na, which raised a $500 mil­lion round (in­clud­ing a sec­ond close) in ear­ly 2015. And As­traZeneca’s Pas­cal So­ri­ot helped get that all start­ed with a whop­ping $240 mil­lion up­front in its 2013 deal, which was tied to $180 mil­lion in mile­stones.

The com­pa­ny de­clined com­ment Mon­day morn­ing.

Mod­er­na CEO Stephane Ban­cel has been build­ing this mes­sen­ger RNA com­pa­ny with a rad­i­cal­ly dif­fer­ent ap­proach to the norm in biotech. In­stead of grab­bing one or two new drugs and set­ting out to gath­er proof-of-con­cept da­ta to help es­tab­lish its sci­en­tif­ic cred­i­bil­i­ty, the com­pa­ny has har­vest­ed a huge wind­fall of cash and built a large or­ga­ni­za­tion be­fore even en­ter­ing the clin­ic. And it did that with­out turn­ing to an IPO.

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.

Ban­cel told me ear­li­er in the month that Mod­er­na had raised $1.5 bil­lion, and pre­sum­ably that in­cludes mon­ey cit­ed in this reg­u­la­to­ry fil­ing. As­traZeneca added $140 mil­lion back at the end of Ju­ly, up­ping its stake in the com­pa­ny to 9%  af­ter the part­ners filed a Eu­ro­pean ap­pli­ca­tion to start a Phase I study of AZD8601, an in­ves­ti­ga­tion­al mR­NA-based ther­a­py that en­codes for vas­cu­lar en­dothe­lial growth fac­tor-A (VEGF-A). As­traZeneca orig­i­nal­ly signed on as a part­ner back in 2013, when new CEO Pas­cal So­ri­ot used it to demon­strate the phar­ma gi­ant’s zeal for big, risky and po­ten­tial­ly rev­o­lu­tion­ary sci­ence projects.

The deal with As­traZeneca cov­ers new drugs for car­dio­vas­cu­lar, meta­bol­ic and re­nal dis­eases as well as can­cer.

Mod­er­na on­ly re­cent­ly pushed its first drugs in­to clin­i­cal de­vel­op­ment, and it’s been scout­ing the Boston area for a new man­u­fac­tur­ing site to pro­duce the hun­dreds of drugs it be­lieves it can make with its mR­NA plat­form.

Ban­cel en­joys noth­ing bet­ter than do­ing things in a big way. So it was no sur­prise that his pre­sen­ta­tion at JP Mor­gan in Jan­u­ary at­tract­ed a stand­ing-room-on­ly crowd of on­look­ers. The Mod­er­na CEO spelled out plans to get the first 6 new drugs in the clin­ic by the end of 2016. The first hu­man study was arranged for the in­fec­tious dis­ease drug mR­NA 1440, which be­gan an ear­ly stage study in 2015.

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.”