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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).