Prepar­ing for new wave of treat­ments, Fu­ji­film drops $55 mil­lion for gene ther­a­py cen­ter

The prepa­ra­tions to serve bio­phar­ma’s ex­plo­sion of gene ther­a­py pipeline can­di­dates con­tin­ues.

Sev­en months ago Ther­mo Fish­er put down $1.7 bil­lion for a ris­ing gene ther­a­py con­tract man­u­fac­tur­er. Catal­ent quick­ly fol­lowed up with a $1.2 bil­lion deal for gene ther­a­py play of its own, ac­quir­ing the Mary­land-based Paragon Bioser­vices.  And now, Fu­ji­film is ex­pand­ing its own ca­pa­bil­i­ties in the field — with the Japan­ese con­glom­er­ate in­vest­ing $120 mil­lion in­to the field and build­ing a “Gene Ther­a­py In­no­va­tion Cen­ter” be­side its re­cent­ly com­plet­ed base in Col­lege Sta­tion, Texas.

The new fa­cil­i­ty will cost $55 mil­lion, em­ploy 100 peo­ple and triple the com­pa­ny’s gene ther­a­py man­u­fac­tur­ing ca­pac­i­ty, Fu­ji­film said. The com­pa­ny did not say how the oth­er $65 mil­lion of its gene ther­a­py in­vest­ment would be spent.

“We are very much aware of the in­cred­i­ble growth in such an im­por­tant ther­a­peu­tic space,” said Mar­tin Mee­son, Pres­i­dent and COO of Fu­ji­film Diosynth Biotech­nolo­gies, US, in a state­ment.  “We know that we need to in­vest now, in tech­nol­o­gy, as­sets and peo­ple in or­der to achieve a mar­ket lead­er­ship po­si­tion.”

Mar­tin Mee­son

Al­though the gene ther­a­py mar­ket is still in its in­fan­cy, the com­pa­ny pro­ject­ed the CD­MO side would be worth $1.7 bil­lion by 2025. Ther­mo Fish­er said the gene ther­a­py man­u­fac­tur­er it ac­quired, Bram­mer Bio, was on pace to take in $250 mil­lion in 2019. And when Catal­ent an­nounced the Paragon deal, they said the com­pa­ny was on tar­get to bring in over $200 mil­lion this year.

The in­vest­ment pales to Fu­ji­film’s high-priced ac­qui­si­tions for cell ther­a­py, a larg­er space cur­rent­ly, and oth­er bi­o­log­ics. In Au­gust, the com­pa­ny pur­chased Bio­gen’s cell-cul­ture-de­rived-bi­o­log­ics fac­to­ry in Den­mark for $890 mil­lion cash. Last year, they spent $800 mil­lion on two cell cul­ture me­dia com­pa­nies, Irvine Sci­en­tif­ic Sales Com­pa­ny and IS Japan, from a Japan­ese oil gi­ant.

The new cen­ter will be 60,000 square feet and op­er­a­tional by 2021, the com­pa­ny said.

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.