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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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