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.

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.

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.

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’ 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) 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.