Con­tin­u­ing rapid ex­pan­sion, Ther­mo Fish­er says it will add on plas­mid DNA man­u­fac­tur­ing site in Cal­i­for­nia

It’s been a whirl­wind week for Ther­mo Fish­er.

Over the course of five days pri­or to Wednes­day, the Mass­a­chu­setts CD­MO had an­nounced two ma­jor ex­pan­sion projects across the globe, both of which will in­crease the com­pa­ny’s foot­print in the vac­cine mar­ket­place. And now, Ther­mo has un­veiled a third ma­jor ex­pan­sion project — this time, a new cGMP fa­cil­i­ty spe­cial­iz­ing in the pro­duc­tion of plas­mid DNA at its Carls­bad, Cal­i­for­nia site.

The 67,000-square-foot fa­cil­i­ty, ex­pect­ed to be com­plet­ed in the first half of 2021, will al­low the man­u­fac­tur­ing gi­ant to ex­pand its clin­i­cal and com­mer­cial ca­pa­bil­i­ties for ther­a­peu­tics in­volv­ing in­de­pen­dent­ly-repli­cat­ing DNA mol­e­cules. The fa­cil­i­ty will add 150 jobs over the next year, Ther­mo Fish­er said in a press re­lease.

Study­ing plas­mid DNA as a crit­i­cal raw ma­te­r­i­al could prompt dis­cov­er­ies of life-sav­ing can­cer treat­ments and aid in mR­NA vac­cine pro­duc­tion.

Mike Shafer

The lat­ter is es­pe­cial­ly rel­e­vant now, as both the Pfiz­er-BioN­Tech and Mod­er­na Covid-19 vac­cines are based around mR­NA tech­nol­o­gy. The Carls­bad site will al­so have the ca­pac­i­ty to pro­duce large-scale plas­mid DNA as a pri­ma­ry drug sub­stance for DNA ther­a­pies. Such ca­pac­i­ty is es­sen­tial, Ther­mo se­nior VP Mike Shafer said in the press re­lease, as the glob­al plas­mids mar­ket is grow­ing so rapid­ly that sup­ply cur­rent­ly can’t meet the pro­ject­ed de­mand.

“Our new state-of-the art site will not on­ly tack­le the sup­ply bot­tle­neck for our cus­tomers, but al­so unique­ly po­si­tions us to de­liv­er ro­bust, end-to-end cell and gene ther­a­py ca­pa­bil­i­ties,” Shafer said. “Our cus­tomers can lever­age our deep in­dus­try knowl­edge and ex­per­tise in the com­plex­i­ties of cell and gene ther­a­py at all points along the path­way to com­mer­cial­iza­tion — from re­search and pre­clin­i­cal de­vel­op­ment to clin­i­cal and now ex­pand­ed com­mer­cial and sup­ply chain ser­vices.”

In ad­di­tion to the Carls­bad fa­cil­i­ty, Ther­mo Fish­er al­so has new fa­cil­i­ties in Rhe­in­felden and Weil am Rhein, Ger­many, go­ing on­line this month and next, re­spec­tive­ly. Those fa­cil­i­ties will fo­cus on clin­i­cal sup­ply chain con­ti­nu­ity, name­ly in spe­cial­ized cold-chain and cryo­genic ex­per­tise.

Ther­mo Fish­er al­so re­cent­ly an­nounced ex­pan­sion projects at fa­cil­i­ties in Greenville, NC; Fer­enti­no and Mon­za, Italy; and Swin­don, Eng­land, to widen the range of op­tions avail­able to cus­tomers, es­pe­cial­ly in the vac­cine are­na.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC Forbion is hopping on the ever-lengthening SPAC train.

To be led by Jasper Bos, who joined Forbion Growth as a general partner back in May just after the fund closed at $428 million, Forbion European Acquisition will target late-stage opportunities in the life sciences industry in Europe to merge with and bring onto Nasdaq.

Cyril Lesser, senior controller at Forbion, will be the CFO while Bos serves as CEO.

Jeff Albers, Blueprint Medicines CEO

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite a swarm of other biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly $500 million on a candidate it thinks will stand out.

Blueprint is putting down $250 million in cash and another $215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it hasn’t been tested in humans, Blueprint says the candidate was “highly brain-penetrant” in preclinical trials, and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.

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