Karen Fallen, Touchlight CEO

Months af­ter big fi­nanc­ing round, Touch­light signs sup­ply agree­ment for Ver­same­b's pipeline

A UK-based CD­MO has land­ed a sup­ply agree­ment with Ver­sameb to pro­vide its dog­gy­bone DNA for the com­pa­ny’s pipeline, in­clud­ing for its lead can­di­date to treat stress uri­nary in­con­ti­nence.

Touch­light will sup­ply Ver­sameb with its en­zy­mat­ic DNA as the biotech pre­pares to en­ter VMB-100 in­to Phase I clin­i­cal tri­als in the sec­ond half of this year. The deal will al­low Ver­sameb to uti­lize Touch­light’s dbD­NA, al­so called dog­gy­bone DNA, for all fu­ture pipeline prod­ucts.

dbD­NA is a lin­ear, dou­ble-strand­ed co­va­lent­ly closed DNA vec­tor, that is adapt­able for a num­ber of ge­net­ic med­i­cines, mak­ing it high­ly scal­able. It elim­i­nates bac­te­r­i­al se­quences and can be pro­duced quick­er than oth­er types of DNA. dbD­NA of­fers a syn­thet­ic al­ter­na­tive to plas­mid RNA, a key part of mR­NA vac­cines and ther­a­pies. It can take just five days to pro­duce ver­sus more typ­i­cal man­u­fac­tur­ing months, and has a small­er man­u­fac­tur­ing foot­print. That means it can be quick­ly scaled up and is high­ly trans­portable.

Touch­light sup­plies DNA as a start­ing ma­te­r­i­al as well as an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent. Be­cause its DNA is syn­thet­ic, CEO Karen Fall­en said that it’s vi­tal to the mar­ket, be­cause the en­zy­mat­ic man­u­fac­tur­ing process can be com­plet­ed in just five days, a huge shift from mi­cro­bial and E. coli man­u­fac­tur­ing.

“What you put in, you get out. It faith­ful­ly repli­cates what you get in, so we don’t have the same sta­bil­i­ty is­sues that you can have with E. coli,” she said in an in­ter­view with End­points News. “They de­cid­ed to use us for not just their lead can­di­date, but all of the mol­e­cules in their pipeline, so very ex­cit­ing for us.”

She added that Touch­light sees the move as sol­id val­i­da­tion of its tech­nol­o­gy.

In Sep­tem­ber, the com­pa­ny an­nounced that it would near­ly dou­ble its work­force both in the UK and North Amer­i­ca from around 65 em­ploy­ees to 125 by the end of the year. That news fol­lowed its $125 mil­lion fi­nanc­ing round in March, which led the com­pa­ny to build the ca­pac­i­ty to triple the pro­duc­tion of dbD­NA. That will, the com­pa­ny hopes, set it­self up to be­come the largest syn­thet­ic DNA man­u­fac­tur­er in the world.

Klaas Zuide­veld

“We are ex­cit­ed to be dri­ving the nec­es­sary ac­tiv­i­ties to take our lead as­set to the clin­ic in the short­est pos­si­ble time­frame,” Ver­sameb CEO Klaas Zuide­veld said in a state­ment. “Work­ing with a com­pa­ny such as Touch­light and to uti­lize dbD­NA as a start­ing ma­te­r­i­al for the pro­duc­tion of our mR­NA ther­a­peu­tics as­sures a pro­duc­tion process which is in­no­v­a­tive and gives a com­pet­i­tive ad­van­tage. The high sta­bil­i­ty, qual­i­ty and speed of­fered by syn­thet­ic repli­ca­tion of DNA, the start­ing ma­te­r­i­al for mR­NA, plays a key role in the pro­duc­tion of Ver­sameb’s pro­pri­etary bi­o­log­i­cal­ly op­ti­mized VER­Sag­ile mR­NA pipeline.”

Tough­light is al­so work­ing with Van­der­bilt Uni­ver­si­ty and the De­fense Ad­vanced Re­search Pro­jects Agency — al­so known as DARPA — on DNA vac­cine de­vel­op­ment for head and neck can­cer and Covid-19, as well as syn­thet­ic DNA-based an­ti­body re­search.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.