With eyes on a poly­mer em­pire prize, French medtech play­er seals $42M in fresh fund­ing

Sur­geons are lim­it­ed by su­tures, wires and sta­ples to re­con­nect tis­sue dur­ing surgery — dou­bly so in min­i­mal­ly in­va­sive pro­ce­dures. Sealants of­fer the promise of re­pair, es­pe­cial­ly for soft tis­sues, like the kind in the lungs or heart. But ex­ist­ing prod­ucts are nei­ther elas­tic nor ad­he­sive enough. En­ter Paris-based medtech play­er Tis­si­um, which claims it has just the fix with a poly­mer that promis­es to do its job on-de­mand, and maybe even de­liv­er drugs — us­ing tech­nol­o­gy orig­i­nal­ly de­vel­oped in the pro­lif­ic lab of MIT’s Bob Langer.

Tis­si­um, for­mer­ly called Gecko Bio­med­ical, has raised €38.75 mil­lion ($42.78 mil­lion) in a se­ries B round of fund­ing as it works on de­vel­op­ing the tech­nol­o­gy be­yond its EU-ap­proved sealant to a poly­mer they want to de­ploy in a num­ber of ways — like an­chor­ing de­vices with­in the body, as a plug, a ve­hi­cle for drug de­liv­ery, as well as an im­plantable de­vice cre­at­ed out­side of the body us­ing a 3D-print­er.

Maria Pereira

The pro­pri­etary tech, which was ini­tial­ly de­vel­oped as a glue to close wounds in ba­bies’ hearts, was cre­at­ed by Maria Pereira, the com­pa­ny’s chief in­no­va­tion of­fi­cer, dur­ing her PhD in bio­engi­neer­ing sys­tems. It is a flex­i­ble, bio­com­pat­i­ble and biore­sorbable ma­te­r­i­al, CEO Christophe Ban­cel said.

The sealant does not poly­mer­ize by it­self or when it comes in con­tact with blood, he claimed in an in­ter­view with End­points News. “The doc­tor will be able to trig­ger when the poly­mer goes from its liq­uid and vis­cous state in­to a sol­id yet fix­able state.”

The prod­uct, Se­talum, is a poly­mer CE-marked as a vas­cu­lar sealant. The ap­proval was based on a sin­gle-arm in pa­tients ne­ces­si­tat­ing a carotid en­darterec­to­my, a sur­gi­cal pro­ce­dure de­signed to re­move a build-up of fat­ty de­posits in the carotid artery. The per­for­mance of the sealant was eval­u­at­ed by the per­cent­age of im­me­di­ate he­mo­sta­sis fol­low­ing clamp re­moval, but en­roll­ment was stopped at 22 pa­tients af­ter im­me­di­ate he­mo­sta­sis was achieved in 85% of them.

When Tis­si­um se­cured its CE mark in 2017, Se­talum was ap­proved for use in a vial. The com­pa­ny is now work­ing on tweak­ing the prod­uct in­to a pre-filled sy­ringe — and hopes to ap­ply for the EU nod for that ver­sion by the end of the year. An ap­pli­ca­tion for an IND to test the prod­uct in the Unit­ed States is planned for ear­ly 2020.

The com­pa­ny has built up its own man­u­fac­tur­ing in­fra­struc­ture and says it can ef­fec­tive­ly syn­the­size dif­fer­ent ver­sions of the poly­mer with dif­fer­ent prop­er­ties, in­clud­ing chang­ing the speed of degra­da­tion and the strength of ad­he­sion.

The French com­pa­ny al­so has plans for a poly­mer em­pire — it wants to ex­pand the tech to de­vel­op a car­dio­vas­cu­lar sealant, a com­plete su­ture­less so­lu­tion for pe­riph­er­al nerve re­pair, a prod­uct for gas­troin­testi­nal surgery and as a drug de­liv­ery de­vice for ENT con­di­tions, Ban­cel said.

The se­ries B in­jec­tion comes from BNP Paribas Développe­ment, the Eu­ro­pean In­vest­ment Fund (EIF), M&L In­vest­ments, ValQuest Part­ners, in ad­di­tion to ex­ist­ing in­vestors BPI France, CM-CIC In­no­va­tion, Cap Dé­cisif Man­age­ment, Omnes Cap­i­tal and Sofinno­va Part­ners.

Found­ed in 2013, the com­pa­ny ini­tial­ly raised $10.8 mil­lion that year, and $25.5 mil­lion in 2016.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Aaron Kantoff (Medicxi)

A Medicxi-backed start­up looks to tack­le treat­ment-re­sis­tant blood can­cers, and it's go­ing af­ter AML first

In the hardest-to-treat blood cancers, resistance to therapy is an existential problem for drug developers looking to permanently stave off tumors. A small biotech is chasing an emerging pathway to stop tumors’ ability to resist treatment, and its work has caught the eye of a couple of big-name investors.

Kurome Therapeutics snared a $15 million Series A round it will use to identify and develop a lead program from its platform looking at dual inhibitors of the IRAK1/4 signaling pathway and FLT3 protein receptors on heme blasts to crack treatment-resistant tumors, the biotech said Thursday.