Karen Fallen, Touchlight CEO

Pfiz­er lines up ac­cess to 'dog­gy­bone DNA' in man­u­fac­tur­ing of mR­NA vac­cines, gene ther­a­pies and more

As Pfiz­er builds a whole fran­chise of ge­net­ic prod­ucts on the cor­ner­stone of its mR­NA Covid-19 vac­cine, it’s test­ing out a new way to man­u­fac­ture them.

Touch­light, which has been net­ting deals in the ever-ex­pand­ing and com­pet­i­tive DNA man­u­fac­tur­ing space, has inked a non-ex­clu­sive patent li­cense agree­ment with Pfiz­er. The deal gives Pfiz­er rights to Touch­light’s en­zy­mat­ic DNA, called dog­gy­bone DNA, or dbD­NA, to man­u­fac­ture and com­mer­cial­ize mR­NA-based vac­cines and ther­a­peu­tics as well as DNA vac­cines and gene ther­a­pies.

Touch­light will re­ceive an up­front pay­ment, as well as clin­i­cal and com­mer­cial mile­stone pay­ments and roy­al­ties up­on com­mer­cial­iza­tion. How­ev­er, no hard fig­ures or oth­er fi­nan­cial de­tails were dis­closed to End­points News.

CEO Karen Fall­en said in an in­ter­view with End­points that the deal with Pfiz­er is in re­sponse to the rise in pop­u­lar­i­ty of RNA vac­cines dur­ing the pan­dem­ic. Touch­light has been in con­tact with play­ers in the RNA field in­clud­ing Pfiz­er but can­not dis­close when ne­go­ti­a­tions ex­act­ly kicked off.

Where­as plas­mid DNA is typ­i­cal­ly man­u­fac­tured in bac­te­r­i­al cells, Touch­light said its dbD­NA plat­form is dif­fer­ent from the rest of the mar­ket in that it us­es en­zymes to am­pli­fy a cir­cu­lar DNA tem­plate, al­low­ing the com­pa­ny to quick­ly — and in a small foot­print — man­u­fac­ture a large quan­ti­ty of GMP dbD­NA vec­tors com­pa­ra­ble to the stan­dard plas­mid DNA. In the mak­ing of mR­NA vac­cines, the dbD­NA would serve as start­ing ma­te­r­i­al.

“It’s great to have our tech­nol­o­gy used by some of the Big Phar­mas, so it’s a re­al­ly nice deal for Touch­light,” Fall­en said.

Pfiz­er will even­tu­al­ly man­u­fac­ture dog­gy­bone DNA in their fa­cil­i­ties for their use but where, when and how it will be ap­plied has al­so not been dis­closed.

Touch­light, which cur­rent­ly has GMP man­u­fac­tur­ing suites up and run­ning at its fa­cil­i­ty in Lon­don, will ex­pand its fa­cil­i­ty and put an ex­tra 11 man­u­fac­tur­ing fa­cil­i­ties in place, which should be live in Q4 of this year, but no fur­ther de­tails were pro­vid­ed.

Tom­my Dun­can

For Touch­light, the com­pa­ny has been on the move over the past year. In 2021, the com­pa­ny re­ceived an ex­ten­sion of a $60 mil­lion fund­ing round which brought their to­tal fundrais­ing round to a to­tal of $125 mil­lion.

Tom­my Dun­can, Touch­light’s chief busi­ness of­fi­cer, said that this fi­nanc­ing was a mas­sive dri­ve for­ward for the com­pa­ny. The com­pa­ny was able to ex­pand across the mR­NA mar­ket, as well as sev­er­al emerg­ing mar­kets, in­clud­ing gene edit­ing, DNA vac­cines and non-vi­ral gene ther­a­py.

The com­pa­ny was al­so able to se­cure a con­tract with Ver­sameb to pro­vide its dbD­NA for the com­pa­ny’s pipeline.

With the fi­nanc­ing squared away, Dun­can said the com­pa­ny has no im­me­di­ate fi­nanc­ing plans or no IPO at the mo­ment and will fo­cus on the broad­er ge­net­ic med­i­cine space.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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