Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The sum­mer be­fore Celli­no CEO and co-founder Nabi­ha Sak­layen start­ed at Har­vard, she lost her grand­moth­er fol­low­ing com­pli­ca­tions to di­a­betes. Be­fore then, she hadn’t tak­en a bi­ol­o­gy class since ninth or tenth grade — the mark of a clas­sic physi­cist — but it was then she de­cid­ed she want­ed the rest to sit at the in­ter­sec­tion of the two for the rest of her ca­reer

Com­bine that with be­ing across the way from the Uni­ver­si­ty’s stem cell in­sti­tute in Cam­bridge, and you get the birth of Celli­no, an au­tonomous cell ther­a­py man­u­fac­tur­ing com­pa­ny that just an­nounced the clos­ing of its Se­ries A.

“I think of my grand­moth­er very fond­ly,” Sak­layen said in a call with End­points News. “That’s def­i­nite­ly been a strong un­der­ly­ing mo­ti­va­tion.”

Celli­no land­ed $80 mil­lion in a Se­ries A led by Leaps by Bay­er, the big phar­ma’s in­vest­ment arm, 8VC and the Hum­boldt Fund. Fe­li­cis Ven­tures and ex­ist­ing in­vestors The En­gine and Khosla Ven­tures al­so con­tributed. So far, the com­pa­ny has raised $96 mil­lion to date.

The com­pa­ny wants to make stem cell-based re­gen­er­a­tive med­i­cines avail­able on a wider scale for el­i­gi­ble pa­tients. Its man­u­fac­tur­ing plat­form tries to com­bine ar­ti­fi­cial in­tel­li­gence and laser tech­nol­o­gy to cut back on ex­pens­es and over­come the lim­i­ta­tions that arise when try­ing to scale.

Through im­age-based ma­chine learn­ing, it trains al­go­rithms to look at im­ages and find in­fo in a con­sis­tent man­ner, some­thing that Sak­layen says ma­chines can do bet­ter than hu­mans. From there, the com­pa­ny us­es the da­ta to fig­ure out what is good, and what is not in the man­u­fac­tur­ing process.

Jür­gen Eck­hardt

Leaps has a port­fo­lio of 50 com­pa­nies and is fo­cused on po­ten­tial­ly break­through tech­nolo­gies that have spe­cif­ic tar­gets. Jür­gen Eck­hardt, the head of Leaps, said in an in­ter­view with End­points that Celli­no was an ob­vi­ous in­vest­ment for this rea­son.

“Cell ther­a­py to­day is a pret­ty la­bor-in­ten­sive process, pret­ty ex­pen­sive, and will not be avail­able for the broad mass­es as of to­day, but we want to sort of de­moc­ra­tize that process of man­u­fac­tur­ing,” Eck­hardt said. “Their vi­sion is to be a cell man­u­fac­tur­ing foundry, where you can pro­duce tar­get­ed cells at a frac­tion of the cost.”

Celli­no is even­tu­al­ly work­ing to­ward “GMP-in-a-box” — a closed sys­tem that can be dropped off at hos­pi­tals that need them to man­u­fac­ture ther­a­pies.

For now, that is an as­pi­ra­tional idea, not yet com­plete. Sak­layen says that the team is some­where in the mid­dle of the de­vel­op­ment, though there is plen­ty more to be learned be­fore tri­als.

It’s a con­cept that sev­er­al oth­er com­pa­nies — like Fabi­an Ger­ling­haus-led Cel­lares and Ger­many’s Cure­Vac — have been work­ing to­ward as well. But it’s be­come even more per­son­al for Sak­layen. Not on­ly did she lose her grand­moth­er be­fore start­ing at Har­vard, but two years ago, her great aunt was di­ag­nosed with Parkin­son’s dis­ease.

“It’s hard to see that there’s no med­ical treat­ments avail­able to her,” she said. “All of the treat­ments are deal­ing with symp­toms, not the dis­ease.”

With that mon­ey, the com­pa­ny is go­ing to boost its soft­ware, ma­chine learn­ing and hard­ware ca­pa­bil­i­ties for the end-to-end man­u­fac­tur­ing of stem cell ther­a­pies, both au­tol­o­gous and al­lo­genic.

So it will look to boost its soft­ware and ma­chine learn­ing teams with the next hir­ing wave. In the age of work-from-home flex­i­bil­i­ty and flu­id in-of­fice re­quire­ments, it could be dif­fi­cult to re­cruit work­ers to the team, es­pe­cial­ly in a re­gion as com­pet­i­tive as greater Boston. But be­cause of the work it’s do­ing, Sak­layen says that the com­pa­ny is com­mit­ted to the re­gion.

It’s lo­cat­ed in the heart of Cam­bridge, MA, on Mass­a­chu­setts Av­enue, across the street from a leg­endary con­cert venue called The Mid­dle East that held con­certs for any­one from Gary Nu­man to Vanil­la Ice, and above a restau­rant found­ed by 8-time James Beard award-win­ning chef Ken Oringer.

“As a com­pa­ny, Boston and Cam­bridge is our heart­beat,” Sak­layen said.

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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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.”

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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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.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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