Fabian Gerlinghaus (Cellares)

Fo­cused on the cell ther­a­py man­u­fac­tur­ing bot­tle­neck, Cel­lares tur­bocharges plans for 'shut­tle' tech

When Cel­lares CEO and co-founder Fabi­an Ger­ling­haus tore his ACL a few years ago, he was brought out­side of a Bay Area hos­pi­tal to the park­ing lot where he re­ceived an MRI in­side a truck. He and his col­leagues hope that the same can be done for cell ther­a­py — one day — and they just re­ceived $82 mil­lion in fund­ing to help do so.

Omar Kur­di

Cel­lares on Wednes­day bagged a Se­ries B round, bring­ing its to­tal fund­ing to $100 mil­lion so far. Those funds will be used to de­vel­op the Cell Shut­tle, a portable fac­to­ry that Cel­lares hopes will dis­rupt the ex­pen­sive and lo­gis­ti­cal­ly com­pli­cat­ed cell ther­a­py man­u­fac­tur­ing process.

The Cell Shut­tle is an end-to-end plant in a box, de­signed to cre­ate an au­to­mat­ed cell ther­a­py plat­form that takes in a pa­tient’s cells at the start and turns out a fin­ished cell ther­a­py prod­uct ready to be in­ject­ed back in­to a pa­tient at the end. Ger­ling­haus and his co-founders, Alex Pesch and Omar Kur­di, see the tech as an an­swer to the the cell ther­a­py’s loom­ing pro­duc­tion bot­tle­neck. They want to en­able phar­ma­ceu­ti­cal com­pa­nies to ef­fec­tive­ly scale and de­ploy the tech wher­ev­er it works best, be it a hos­pi­tal or a clean room in a man­u­fac­tur­ing fa­cil­i­ty.

“How do we man­u­fac­ture cell ther­a­pies at scale and at com­mer­cial scale, where all of a sud­den we’re not talk­ing about a few dozen pa­tients in a clin­i­cal tri­al but tens of thou­sands and hun­dreds of thou­sands of pa­tients per year per ther­a­peu­tic,” Ger­ling­haus said in an in­ter­view with End­points News. “That prob­lem is re­al­ly new … and it’s un­solved. And that’s an op­por­tu­ni­ty we saw as a found­ing team.”

Alex Pesch

Decheng Cap­i­tal, a new in­vestor, and ex­ist­ing in­vestor Eclipse Ven­tures led the fund­ing, with Skyviews Life Sci­ence and 8VC al­so par­tic­i­pat­ing. The com­pa­ny is on track for mar­ket en­try with a pro­duc­tion qual­i­ty sys­tem in 2023, and to main­tain that time­line the com­pa­ny will have to staff up sub­stan­tial­ly.

With cell and gene ther­a­py’s rel­a­tive­ly young age, the in­dus­try has been forced to think out­side the box. There are cur­rent­ly 450,000 pa­tients to­day who could ben­e­fit from CAR-T ther­a­pies alone, a num­ber that’s ex­pect­ed to grow over time. Right now, just 1% of pa­tients are able to ac­cess those ther­a­pies, due in large part to man­u­fac­tur­ing de­fi­cien­cies ac­cord­ing to Cel­lares. Ger­ling­haus says that ex­perts project be­tween 10 and 20 gene ther­a­pies ap­proved each year be­tween now and 2025, yet on­ly be­tween 5% and 10% of the man­u­fac­tur­ing ca­pa­bil­i­ties al­ready ex­ist. That’s cre­at­ing a bot­tle­neck; one that Cel­lares, among sev­er­al com­pa­nies, aims to take on.

That search has turned up in­ter­est­ing re­sults. Lentivi­ral play­er Avro­Bio, for in­stance, has re­tooled pro­duc­tion “pods” typ­i­cal­ly uti­lized for bone mar­row trans­plants for use in mod­i­fy­ing pa­tients’ stem cells. They’re housed in CMO clean rooms across the world, in­clud­ing at sites in Hous­ton, Mel­bourne, San Jose and Maas­tricht. The goal is much the same: Cut the foot­print and speed pro­duc­tion.

Cel­lares says the shut­tle can cut costs by 75% through au­toma­tion and the ac­cel­er­a­tion of time­lines. It’s al­so able to take the cells from 10 dif­fer­ent pa­tients, and man­u­fac­ture the ther­a­pies si­mul­ta­ne­ous­ly. Ide­al­ly, the shut­tle will elim­i­nate the two main sources of process er­ror: op­er­a­tor mis­takes and the risk of con­t­a­m­i­na­tion.

“Where sci­en­tists have to stop and use the bath­room or take a lunch…the ro­bot doesn’t sleep,” Ger­ling­haus said.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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