Syn­thet­ic DNA play­er Touch­light scores $60M round to more than triple man­u­fac­tur­ing ca­pac­i­ty as mR­NA gets hot

With the twin au­tho­riza­tions of Pfiz­er/BioN­Tech’s and Mod­er­na’s mR­NA vac­cines for Covid-19 late last year, the mar­ket for start­ing ma­te­ri­als for that type of shot has seen a big boost. One UK play­er with a new way to man­u­fac­ture DNA, a key pre­cur­sor to pro­duc­ing mR­NA, is cash­ing a siz­able check to scale up in a big way.

Touch­light has wran­gled $60 mil­lion in fi­nanc­ing to add 11 pro­duc­tion suites to its Lon­don site spe­cial­iz­ing in pro­duc­ing syn­thet­ic DNA it says can be pro­duced much faster than nor­mal plas­mid DNA, the com­pa­ny said Wednes­day.

The ex­pan­sion will en­able Touch­light to triple pro­duc­tion of its pro­pri­etary vec­tor, dbD­NA or what it calls “dog­gy­bone” DNA, by Q1 2022. The vec­tor can be used in ap­pli­ca­tions as wide as mR­NA vac­cines and gene ther­a­pies, and Touch­light said its es­ti­mat­ed ca­pac­i­ty could be enough to sup­ply up to 1 bil­lion Covid-19 shot dos­es per month.

Adding that ca­pac­i­ty will take Touch­light’s foot­print at its Lon­don head­quar­ters to more than 7,500 square feet and will re­quire hir­ing at least 60 new em­ploy­ees by the time the ex­pan­sion is op­er­a­tional. The com­pa­ny’s to­tal pro­duc­tion suites will num­ber 15 af­ter the in­vest­ment. The round was led by Brid­ford In­vest­ments Lim­it­ed.

Some of Touch­light’s move is ob­vi­ous­ly meant to ad­dress the man­u­fac­tur­ing crunch for Covid-19 vac­cines, but the firm doesn’t see a ma­jor slow­down in de­mand once the pan­dem­ic comes to a close.

“The ge­net­ic med­i­cine in­dus­try is boom­ing, and we don’t ex­pect any slow­ing down of de­mand,” said Karen Fall­en, CEO of Touch­light DNA Ser­vices, in a state­ment. “Avail­abil­i­ty of plas­mid DNA has be­come a bot­tle­neck which we are ide­al­ly po­si­tioned to ad­dress.”

Fall­en, a for­mer bi­o­log­ics man­u­fac­tur­ing head at Lon­za, came on board in Oc­to­ber as the firm was look­ing to rapid­ly scale up giv­en an in­crease in de­mand. At Lon­za, Fall­en served as pres­i­dent of mam­malian and mi­cro­bial de­vel­op­ment and man­u­fac­tur­ing and guid­ed 4,500 work­ers at 10 sites spread over three con­ti­nents.

In Feb­ru­ary, Fall­en told End­points News she chose to jump to the rel­a­tive un­known Touch­light af­ter de­cid­ing she want­ed a chance to try some­thing new.

“It was my time, I think, just to think about what do I want to do in the last 10 to 15 years of my ca­reer,” she said. “And I de­cid­ed ac­tu­al­ly that I just want­ed to do some­thing dif­fer­ent. I learned every­thing that I know at Lon­za, and had a fan­tas­tic time (there). It’s a bril­liant com­pa­ny — but I just thought I want­ed to do some­thing dif­fer­ent.”

The com­pa­ny’s al­ter­na­tive to plas­mid DNA has re­ceived re­newed in­ter­est giv­en the ap­provals of mR­NA vac­cines for Covid-19 from Pfiz­er/BioN­Tech and Mod­er­na. To make mR­NA vac­cines, man­u­fac­tur­ers first need to pro­duce bulk amounts of DNA, which they then mix with ar­ti­fi­cial en­zymes that trans­late the code in­to mR­NA.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.