Biotech uni­corn Mod­er­na gam­bles $110M on a ground­break­ing mR­NA man­u­fac­tur­ing fa­cil­i­ty, blue­prints plant #2

Start­ing in a few weeks, Mod­er­na will be­gin work on the biggest biotech man­u­fac­tur­ing fa­cil­i­ty in the world ded­i­cat­ed to ear­ly stage R&D, pro­duc­ing its mes­sen­ger RNA drugs for every­thing from tox work through Phase II stud­ies. And with the first crit­i­cal round of clin­i­cal da­ta due to ar­rive in H1 2017, Mod­er­na CEO Stephane Ban­cel says the biotech is al­ready blue­print­ing an­oth­er fa­cil­i­ty that may well dwarf the first $110 mil­lion man­u­fac­tur­ing project.

Ban­cel and his ex­ec­u­tive crew have land­ed a site for their first 200,000-square-foot fa­cil­i­ty in Nor­wood, MA, not far from the biotech’s head­quar­ters in Cam­bridge. And char­ac­ter­is­ti­cal­ly, they’re mov­ing as fast as they can to get the dirt fly­ing.

Mod­er­na is think­ing big about every as­pect of drug de­vel­op­ment. That starts with rais­ing cash: Now close to $2 bil­lion. Staff: 460 and grow­ing fast. And pipeline projects: 11. There are al­so four spin­out ven­tures work­ing on per­son­al­ized can­cer vac­cines and on­col­o­gy, in­fec­tious dis­eases and rare ail­ments.

The score on hu­man tri­al out­comes? Ze­ro so far, but that will soon change.

This new fa­cil­i­ty will even­tu­al­ly be able to make up to 100 mR­NA lots an­nu­al­ly, a num­ber that won’t mean much to any­one not schooled in biotech man­u­fac­tur­ing. But the ex­pla­na­tion pro­vides some in­sights in­to what Mod­er­na has set out to achieve.

In the first dozen pro­grams to make it to the clin­ic, ex­plains Ban­cel, in­ves­ti­ga­tors can mix mR­NA in a sin­gle vial, or lot. But in the very near fu­ture, they’ll need sev­er­al dif­fer­ent anti­gens in the same vial, or sev­er­al lots. For one up­com­ing vac­cine study for a par­tic­u­lar­ly tough virus that Mod­er­na plans to tack­le, it will take sev­en.

And af­ter Phase II, what then?

Ban­cel says he is al­ready look­ing on build­ing out the man­u­fac­tur­ing Mod­er­na will need for Phase III and com­mer­cial quan­ti­ties, a project that could con­sume any­where from $200 mil­lion to $400 mil­lion. Once the first clin­i­cal da­ta starts to come in, he says, some fast-mov­ing projects could move in­to Phase III in less than a year. And that will spur more ex­pan­sion.

Mod­er­na has been work­ing with a va­ri­ety of groups, in­clud­ing a team from GE, to ramp up new tech­nol­o­gy to make the man­u­fac­tur­ing work more ef­fi­cient, with­out get­ting tripped up by de­con­t­a­m­i­na­tion pit­falls.

“We try to use a lot of equip­ment that can be reused,” says the CEO, “so that you can go much faster.”

These man­u­fac­tur­ing projects in the Boston area have be­come a plum catch in the eco­nom­ic de­vel­op­ment field. And for one ob­vi­ous rea­son: More jobs. The plan at Mod­er­na now is to shift 100 of their work­ers to the new site once it be­comes op­er­a­tional in ear­ly 2018. And they’ll add 100-plus em­ploy­ees once it’s in full swing.

The gam­ble, and it’s as big as Mod­er­na’s goals, is that they can build a glob­al op­er­a­tion from scratch, with a full suite of tech­nolo­gies and fa­cil­i­ties that can keep pace with its am­bi­tions — and, they hope, with­out any com­pa­ny-end­ing blowups along the way.

Mod­er­na’s been able to stay on track to that goal, gain­ing big in­vestors like As­traZeneca along the way who have bought in to the vi­sion. And un­like vir­tu­al­ly every oth­er biotech in ex­is­tence, they built up their ex­ten­sive in­fra­struc­ture with­out a sin­gle shred of hu­man clin­i­cal da­ta to prove that their drugs ac­tu­al­ly work in peo­ple by spurring pa­tients’ cells to pro­duce drugs.

The da­ta, though, are com­ing. And Mod­er­na be­lieves it can quick­ly start to rack up a wide range of tri­al re­sults, lay­ing out a smor­gas­bord of da­ta rather than plug along on 2-3 lead proof-of-con­cept pro­grams.

Mod­er­na is al­so work­ing to stay out front of mR­NA com­peti­tors like BioN­Tech, which co­in­ci­den­tal­ly just struck a ma­jor col­lab­o­ra­tion pact with Genen­tech. What start­ed out as a biotech race has quick­ly swelled in­to a show­down that in­cludes some of the world’s biggest drug de­vel­op­ers. Wa­gers rarely get this big, this ear­ly.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.