Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

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.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

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.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

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.”

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

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.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

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.