A start­up in the bustling Boston-area biotech hub hopes its new tech­nol­o­gy has solved a time-con­sum­ing as­pect of de­vel­op­ing drugs that re­ly on cell ther­a­py: hav­ing to re­move stem cells by hand, in­di­vid­u­al­ly, dur­ing the man­u­fac­tur­ing process.

Celli­no, a re­gen­er­a­tive med­i­cine com­pa­ny, an­nounced Mon­day that it con­clud­ed a $16 mil­lion seed fi­nanc­ing round that will fur­ther ad­vance tech­nol­o­gy that us­es ar­ti­fi­cial in­tel­li­gence and a per­son­al­ized tis­sue and cell plat­form and ul­ti­mate­ly seeks to gen­er­ate au­tol­o­gous in­duced pluripo­tent stem cells at scale.

CEO Nabi­ha Sak­layen found­ed Celli­no in 2017 while still in her mid-20s (she’s since gone on to be named to Forbes’ 30 Un­der 30 list and MIT Tech Re­view’s 35 In­no­va­tors Un­der 35 list), and told End­points News in a state­ment that the tech­nol­o­gy has the po­ten­tial to elim­i­nate “a ma­jor bot­tle­neck” in the stem cell in­dus­try.

“The com­pa­ny was found­ed to fill a crit­i­cal gap in the stem cell in­dus­try by en­gi­neer­ing per­son­al­ized stem cells with laser-pre­ci­sion in an au­to­mat­ed, soft­ware-dri­ven, and closed man­ner. Cur­rent au­tol­o­gous process­es for gen­er­at­ing in­duced pluripo­tent stem cells are not scal­able due to ex­ten­sive man­u­al han­dling, high vari­abil­i­ty, and low yield,” she said. “By pro­gress­ing to­wards the ul­ti­mate goal of scal­able stem cell man­u­fac­tur­ing, on­ly then will we ful­fill the promise of per­son­al­ized cell ther­a­pies, by en­abling ac­cess to all pa­tients.”

The tech­nol­o­gy it­self func­tions by au­tomat­ing stem cell pro­duc­tion us­ing im­age-guid­ed ma­chine learn­ing, sin­gle-cell laser pro­cess­ing, and ro­bot­ics. Celli­no said in a press re­lease that the stan­dard­iza­tion of man­u­fac­tur­ing in a closed for­mat al­lows it to eas­i­ly scale stem cell pro­duc­tion from the pre­clin­i­cal process all the way to com­mer­cial man­u­fac­tur­ing.

The ap­pli­ca­tions, they say, can span every­thing from neu­rode­gen­er­a­tive dis­eases, reti­nal dis­or­ders to skin con­di­tions — all of which they are ex­plor­ing for the in-house pipeline.

In­vest­ment in the $16 mil­lion fund­ing round was spear­head­ed by The En­gine and Khosla Ven­tures, with par­tic­i­pa­tion from Hum­boldt Fund and 8VC. In a state­ment, Alex Mor­gan, a part­ner at Khosla Ven­tures, was down­right bull­ish on Celli­no’s fu­ture and how its tech­nol­o­gy could al­ter the stem cell ther­a­peu­tics in­dus­try.

“Com­pa­nies that dis­rupt en­tire in­dus­tries and process­es don’t nor­mal­ly orig­i­nate from a sin­gle dis­ci­pline,” he said. “By us­ing sin­gle-cell laser pro­cess­ing and AI-guid­ed au­toma­tion to en­gi­neer cells at scale, Celli­no is well-po­si­tioned to lead the next-gen­er­a­tion of per­son­al­ized re­gen­er­a­tive med­i­cines.”

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.