Lalo Flores (Century)

As al­lo­gene­ic cell ther­a­py ap­proach­es flour­ish, Cen­tu­ry loads up $160M to scale iP­SC plat­form for CAR-T, CAR-NK

La­lo Flo­res is con­fi­dent he’s found the way for­ward in cell ther­a­py.

The feel­ing, to be sure, is not ex­clu­sive. Thanks to splashy com­pa­nies like Al­lo­gene and Arti­va, bio­phar­ma is well aware of the promis­es of al­lo­gene­ic ther­a­pies as next-gen­er­a­tion al­ter­na­tives to the au­tol­o­gous CAR-Ts that have al­ready made it to the mar­ket. But few­er are talk­ing about a fin­er dis­tinc­tion with­in that al­lo­gene­ic group: Where do you find the cells to en­gi­neer and turn in­to a fi­nal off-the-shelf prod­uct?

While most have opt­ed for donor cells, Cen­tu­ry Ther­a­peu­tics — where Flo­res is CEO — is bank­ing on in­duced pluripo­tent stem cells.

Al­most two years af­ter launch­ing with $250 mil­lion in cash and three em­ploy­ees, it’s col­lect­ed $160 mil­lion to fu­el the now 100-per­son team’s dash to the clin­ic.

In par­al­lel with all the ad­vances in cell en­gi­neer­ing over the years, there’s been a sim­i­lar evo­lu­tion in the sci­ence of re­pro­gram­ming skin or blood cells in­to an em­bry­on­ic-like state and coax­ing them in­to T or NK cells. Fate Ther­a­peu­tics, a J&J-part­nered pi­o­neer now in the clin­ic, has done much to ed­u­cate the field about it, and more re­cent­ly we’ve seen star­tups like Notch emerge; Cen­tu­ry wants to join them in the lead­ing spot, Flo­res said.

The room for im­prove­ment, af­ter all, is sig­nif­i­cant. Even in the few lym­phoma in­di­ca­tions where Kym­ri­ah and Yescar­ta have been ap­proved, not all pa­tients achieve a com­plete re­sponse and many who do would re­lapse.

“So clear­ly what that means is that there was not enough pres­sure on the tu­mor, there were enough cells that sur­vived that treat­ment […] and that’s the rea­son pa­tients re­lapse,” Flo­res said. “Our goal at Cen­tu­ry is to in­crease the dura­bil­i­ty of the re­spons­es.”

Cen­tu­ry is “plat­form ag­nos­tic” and there­fore de­vel­op­ing both CAR-T and CAR-NKs cre­at­ed with its iP­SCs. The lead pro­gram is a CD19 CAR-T that they hope to steer in­to a hu­man tri­al by 2022.

In ad­di­tion to the anti­gen tar­gets, the biotech has de­vised a com­bi­na­tion of three ge­net­ic ed­its to pre­vent im­mune re­jec­tion of the ther­a­peu­tic cells — open­ing up the pos­si­bil­i­ty to dose sev­er­al times un­til the pa­tient re­sponds.

With each new pro­gram, once they fi­nal­ize all the mod­i­fi­ca­tions Cen­tu­ry would iso­late a sin­gle clone to start what they call a mas­ter cell bank.

“It may take you a cou­ple of years to get to that point,” Flo­res said. “But once you have a mas­ter cell bank, that is the be­gin­ning of your man­u­fac­tur­ing process. And from there it on­ly takes you 30 days to make a man­u­fac­tur­ing run that will sup­ply thou­sands of dos­es.”

Ul­ti­mate­ly, he en­vi­sions Cen­tu­ry’s ther­a­pies to be stored as a frozen prod­uct in hos­pi­tals. The pre­clin­i­cal pipeline goes af­ter a slate of hema­to­log­i­cal ma­lig­nan­cies as well as sol­id tu­mors like glioblas­toma, where they would de­ploy a bis­pe­cif­ic CAR. The sub­stan­tial back­ing from Ver­sant and Bay­er in its Se­ries B has helped Flo­res re­cruit a ex­perts in pro­tein en­gi­neer­ing, gene edit­ing and man­u­fac­tur­ing, with him man­ag­ing the head­quar­ters in Philadel­phia, R&D chief Hyam Lev­it­sky lead­ing a team in Seat­tle and the group that was for­mer­ly Em­pir­i­ca Ther­a­peu­tics set­ting up a third of­fice in Cana­da af­ter Cen­tu­ry ac­quired the com­pa­ny.

More re­cent­ly, it’s leased the space for an man­u­fac­tur­ing fa­cil­i­ty in New Jer­sey, just 45 min­utes from the HQ, adding in-house ca­pac­i­ty to com­ple­ment the ex­ist­ing pro­duc­tion un­der a part­ner­ship with Fu­ji­film Cel­lu­lar Dy­nam­ics.

“Each time you de­vel­op a prod­uct, you be­gin the whole process of learn­ing how to scale up man­u­fac­tur­ing,” he said. “Go­ing to this jour­ney, there’s many learn­ings and it’s re­al­ly im­por­tant to cap­ture all those learn­ings with­in your own em­ploy­ees, your own sci­en­tists, or with­in your close part­ner as we have in FC­DI.”

They could be tak­ing those learn­ings to Nas­daq soon. Though Flo­res notes Cen­tu­ry now has two to three years of run­way, the Se­ries C syn­di­cate — Fi­deli­ty, the Fed­er­at­ed Her­mes Kauff­man Funds, RA Cap­i­tal, Lo­gos Cap­i­tal, Or­biMed, Mar­shall Wace, Qatar In­vest­ment Au­thor­i­ty, Avid­i­ty Part­ners, and Oc­ta­gon Cap­i­tal — fea­tures well-known crossover play­ers with whom he will be ex­plor­ing an IPO.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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