$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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.