(From left to right) Cellino co-founders Marinna Madrid, Nabiha Saklayen, and Matthias Wagner

Khosla Ven­tures helps seed a next-gen re­gen­er­a­tive med­i­cines start­up boast­ing AI-based stem cell cul­tur­ing tech­nol­o­gy

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.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.