Al­most ex­act­ly two years af­ter its de­but at the 2020 JP Mor­gan con­fab — and on the heels of a new part­ner­ship with the gene edit­ing ex­perts at In­tel­lia — a Gilead-backed, au­toim­mune dis­ease-fo­cused start­up has re­turned to the well with a clear­er out­line of just what it plans to do with its CAR-T plat­form.

Kyver­na brought in $85 mil­lion in its over­sub­scribed Se­ries B, the com­pa­ny an­nounced Wednes­day. North­pond Ven­tures led the round, and West­lake Vil­lage BioPart­ners, Vi­da Ven­tures, Gilead and In­tel­lia all con­tributed as well.

The mon­ey will go to­ward ad­vanc­ing lead can­di­date KYV-101, an au­tol­o­gous an­ti-CD19 CAR-T ther­a­py tar­get­ing au­toim­mune dis­eases such as lu­pus nephri­tis, sys­temic scle­ro­sis and in­flam­ma­to­ry my­opathies. The ther­a­py is head­ed to clin­i­cal de­vel­op­ment, if all goes ac­cord­ing to plan, in the first half of this year.

Hav­ing li­censed the CD19 con­struct from the NIH, the biotech holds the rights to use it al­so in al­lo­gene­ic can­di­dates.

Kyn­er­va is de­vel­op­ing CAR-T cell ther­a­pies from both au­tol­o­gous and al­lo­gene­ic sources, as well as a syn­thet­ic ver­sion of Tregs. The com­pa­ny raised $25 mil­lion in a Se­ries A round back in 2020. Gilead was a key backer in that round, and inked a li­cense agree­ment to de­vel­op en­gi­neered T cell ther­a­pies based on its Treg plat­form and syn­Notch tech­nol­o­gy from Kite, the Gilead sub­sidiary. Un­der that deal, Kyver­na took on the re­search and clin­i­cal du­ties through proof-of-con­cept.

The funds from the Se­ries B will al­so help fu­el the de­vel­op­ment of KYV-201, for which In­tel­lia and Kyver­na have an ex­clu­sive part­ner­ship. One of the lead­ing gene edit­ing com­pa­nies, In­tel­lia made noise in Sep­tem­ber when the FDA ac­cept­ed its IND ap­pli­ca­tion for the ex­per­i­men­tal acute myeloid leukemia treat­ment NT­LA-5001. The deal, an­nounced just a few weeks ago, gives Kyver­na ex­clu­sive rights to In­tel­lia’s al­lo­gene­ic cell en­gi­neer­ing plat­form to de­vel­op KYV-201. In ex­change, In­tel­lia gets an eq­ui­ty stake and cer­tain de­vel­op­men­tal and com­mer­cial mile­stones, as well as roy­al­ties on fu­ture sales.

In­tel­lia al­so has an op­tion to de­vel­op and com­mer­cial­ize KYV-201; in that case, it would fork over an opt-in fee and share half the de­vel­op­ment costs and fu­ture sales rev­enue.

“One thing that drew me to Kyver­na is the de­sire to be there from the very be­gin­ning, be in­volved in what can be a rev­o­lu­tion in the way we treat pa­tients with au­toim­mune dis­ease,” CEO Do­minic Borie said in an in­ter­view with End­points News. “Cell ther­a­py is go­ing to be trans­for­ma­tion­al for our pa­tients. I think it’s very ex­cit­ing to be lead­ing a com­pa­ny that is fo­cused 100% on that.”

Just a few months ago, Kyver­na land­ed for­mer Genen­tech CEO Ian Clark as its new chair of the board of di­rec­tors, and Karen Walk­er as chief tech­nol­o­gy of­fi­cer. As it goes for­ward in hir­ing more em­ploy­ees to keep up with the growth tak­ing shape, Borie said that a team will be built out un­der Walk­er.

“She will be in­stru­men­tal in de­vel­op­ing our man­u­fac­tur­ing ca­pa­bil­i­ties,” he said. “We’ll build un­der her a very strong team that will com­ple­ment our R&D op­er­a­tions.”

Borie said that in ad­di­tion to the part­ner­ships with Gilead and In­tel­lia, Kyver­na is work­ing to­ward adding even more “in both di­rec­tions,” he said.

As part of the fi­nanc­ing, North­pond di­rec­tor Shaan Gand­hi and RTW’s Chris Liu will join as Kyver­na’s board mem­bers and ob­servers, re­spec­tive­ly.

“When it comes to treat­ing au­toim­mune dis­eases, the in­dus­try has reached a sci­en­tif­ic tip­ping point,” Gand­hi said. “The cell ther­a­pies in Kyver­na’s pipeline hold sig­nif­i­cant promise for mod­u­lat­ing the im­mune sys­tem in such a way as to achieve op­ti­mal and long-last­ing dis­ease con­trol.”

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.