Fu­ji­film dou­bles down on Boston foothold, rent­ing some ma­jor legroom to chase cell and gene ther­a­pies

Fu­ji­film has fi­nal­ly crossed the t’s and dot­ted the i’s on a new pub­lic-pri­vate part­ner­ship for a cen­ter fo­cused on ge­net­i­cal­ly mod­i­fied cell ther­a­pies af­ter the idea first came to fruition in late 2019.

On Thurs­day, the Japan­ese con­glom­er­ate and the Mass­a­chu­setts Cen­ter for Ad­vanced Bi­o­log­i­cal In­no­va­tion and Man­u­fac­tur­ing an­nounced that they’d se­cured $76 mil­lion in fund­ing and signed a lease for a 40,000 square-foot site in the greater Boston area.

The cen­ter will be housed at The Ar­se­nal on the Charles in Wa­ter­town, which al­ready counts NASH play­er Enan­ta Phar­ma­ceu­ti­cals as one of its ten­ants.

The move pro­pels Fu­ji­film even fur­ther up the chain of play­ers in the biotech in­dus­try as its CD­MO arm Fu­ji­film Diosynth Biotech­nolo­gies has made ma­jor in­roads in re­cent months, gar­ner­ing in­ter­est in its vi­ral vec­tor ca­pa­bil­i­ties for Covid-19 vac­cines.

The new fa­cil­i­ty will pri­or­i­tize R&D in cell and gene ther­a­pies, gene edit­ing and im­munother­a­pies, Fu­ji­film said. Fu­ji­film Diosynth will of­fer GMP con­tract process de­vel­op­ment and var­i­ous man­u­fac­tur­ing ser­vices for its role in the sprawl­ing new in­no­va­tion cen­ter.

CABIM will host eight clean­rooms that will be con­fig­ured to pro­duce both cell and vi­ral vec­tor prod­ucts, in ad­di­tion to qual­i­ty con­trol, lab and of­fice space, and gen­er­al col­lab­o­ra­tive space for the nu­mer­ous stake­hold­ers in what’s be­come one of the world’s lead­ing life sci­ence hubs. The $76 mil­lion will cov­er con­struc­tion costs, 40 full-time em­ploy­ees, and the cen­ter’s dai­ly op­er­a­tions once it starts up in ear­ly 2022.

The fund­ing haul came to­geth­er as part of equal in­vest­ments from Fu­ji­film, Har­vard Uni­ver­si­ty, Mass­a­chu­setts In­sti­tute of Tech­nol­o­gy, Cy­ti­va and Alexan­dria Re­al Es­tate Eq­ui­ties.

“This col­lab­o­ra­tion sup­ports our larg­er health­care strat­e­gy to uti­lize the com­bined strength of the Fu­ji­film Group’s prod­ucts and ser­vices to of­fer per­son­al­ized life-al­ter­ing treat­ment op­tions to clin­i­cians and their pa­tients,” said Takatoshi Ishikawa, Fu­ji­film’s chief life sci­ence of­fi­cer.

Just 14 days in­to the new year, Fu­ji­film has been re­mark­ably busy. On Jan. 4, the com­pa­ny an­nounced a $40 mil­lion in­vest­ment in a new Boston-area head­quar­ters for Fu­ji­film Diosynth to in­crease its vi­ral vec­tor and ad­vanced ther­a­py ca­pac­i­ties (which it spec­i­fied Thurs­day is sep­a­rate from the CABIM fa­cil­i­ty), and three days lat­er an­nounced an eye-pop­ping $2 bil­lion in­vest­ment for a new large-scale cell cul­ture pro­duc­tion plant near one of its ex­ist­ing US fa­cil­i­ties.

The lo­ca­tion of the $2 bil­lion fa­cil­i­ty has not yet been de­ter­mined, but it’s ex­pect­ed to be op­er­a­tional by 2025 and help boost Fu­ji­film Diosynth Biotech­nolo­gies’ cu­mu­la­tive growth by 20% by March 2026.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.