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.

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.