Fabian Gerlinghaus (Cellares)

A cou­ple months af­ter land­ing $100 mil­lion in fund­ing, Cel­lares grabs part­ner for its Cell Shut­tle

The team at Cel­lares hopes that its Cell Shut­tle is the fu­ture of end-to-end cell ther­a­py man­u­fac­tur­ing. On Wednes­day, the com­pa­ny an­nounced that one more com­pa­ny has signed up to work along­side it.

Po­sei­da has signed on to pro­vide ther­a­pies for the Cell Shut­tle, a portable fac­to­ry Cel­lares hopes will dis­rupt the ex­pen­sive and lo­gis­ti­cal­ly com­pli­cat­ed cell ther­a­py man­u­fac­tur­ing process. The com­pa­ny is the third to ink a deal with Cel­lares, which is based out of South San Fran­cis­co, CA. Cel­lares has al­ready has been col­lab­o­rat­ing with PACT Phar­ma and the Fred Hutchin­son Can­cer Re­search Cen­ter.

“We were very sys­tem­at­ic about how we se­lect po­ten­tial part­ners, and re­al­ly, amongst oth­er things what we were look­ing for were phar­ma com­pa­nies that have a very deep pipeline, so not a one-trick pony but ide­al­ly many dif­fer­ent as­sets, al­ready clin­i­cal stage, dif­fer­ent cell ther­a­py modal­i­ties,” CEO Fabi­an Ger­ling­haus said in an in­ter­view with End­points News. “In Po­sei­da’s case, they meet all of those cri­te­ria.”

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. The in­no­va­tion could be an an­swer to the pro­duc­tion bot­tle­neck that has im­pact­ed the world of cell ther­a­py.

The shut­tle would al­low 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. Cel­lares land­ed a Se­ries B round of fundrais­ing in May, bring­ing its to­tal fund­ing to $100 mil­lion so far.

Po­sei­da has two pa­tient-de­rived CAR-T prod­uct can­di­dates in the clin­ic right now, in­clud­ing P-BC­MA-101 for pa­tients with re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma and P-PS­MA-101 for metasta­t­ic cas­trate-re­sis­tant prostate can­cer. Po­sei­da will eval­u­ate the shut­tle pro­to­types, and give back da­ta and feed­back to im­prove per­for­mance and help get the tech ready for the mar­ket.

The com­pa­ny has off-the-shelf ver­sions of both P-BC­MA-101 and P-PS­MA-101, and is ex­plor­ing TCR-T, an an­ti-c-kit CAR-T, nat­ur­al killer cells and ge­net­i­cal­ly mod­i­fied hematopoi­et­ic stem cells. The con­nec­tion came through Carl June, an on­col­o­gist and pro­fes­sor at the Uni­ver­si­ty of Penn­syl­va­nia who is an ad­vi­sor to Cel­lares and a mem­ber of the Po­sei­da ad­vi­so­ry board.

“We’re al­so look­ing for part­ners that re­al­ly get it and are ex­cit­ed to be work­ing with us and are the first adopters and cham­pi­ons,” Ger­ling­haus said. “(Part­ners) who say ‘look, we have some imag­i­na­tion, we see this as the fu­ture of cell ther­a­py man­u­fac­tur­ing and we want to be a part of that, we’re in.’ We found that in Po­sei­da, and they’ve been very proac­tive.”

Cel­lares is in the process of or­ga­niz­ing user stud­ies right now, and gath­er­ing in­for­ma­tion about how the Cell Shut­tle in­ter­acts with a com­pa­ny’s can­di­dates helps Cel­lares inch clos­er to the end goal. So far, Ger­ling­haus says that the com­pa­ny has made two small tweaks and one “not-so small” change to the shut­tle as a re­sult of its work with ex­ist­ing part­ners.

“Hap­py to re­port that the ear­ly part­ner­ship pro­gram is work­ing as de­signed, it’s ac­tu­al­ly de­liv­er­ing on its pur­pose, and you can quote me on that,” he said Mon­day.

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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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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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.