Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Mon­ey is fly­ing for com­pa­nies promis­ing to rev­o­lu­tion­ize the way clin­i­cal tri­als are con­duct­ed. Leaps by Bay­er is the lat­est to get be­hind one of these play­ers, lead­ing a $200 mil­lion ven­ture round for Hu­ma Ther­a­peu­tics and its dig­i­tal “hos­pi­tal at home” tech.

Lon­don-based Hu­ma un­veiled a $130 mil­lion Se­ries C on Wednes­day, which it will use to ex­pand its dig­i­tal plat­form in the US, Asia and the Mid­dle East. As part of the round, the com­pa­ny can ex­er­cise an­oth­er $70 mil­lion com­mit­ment lat­er on.

“We’re al­ready demon­strat­ing how ‘hos­pi­tal at home’ can trans­form health­care, and how de­cen­tral­ized clin­i­cal tri­als can ad­vance re­search in ways that weren’t imag­in­able even one year ago,” CEO Dan Vah­dat said in a state­ment. “Now we want to ac­cel­er­ate the pace of change and con­tin­ue to in­no­vate for bet­ter care and re­search world­wide.”

Hu­ma boasts wear­able tech­nol­o­gy and a pa­tient app that helps re­searchers pre­screen par­tic­i­pants, con­duct re­mote vis­its via tele­health, track med­ica­tion and col­lect re­al-life da­ta. The com­pa­ny says its plat­form can dou­ble clin­i­cal ca­pac­i­ty and re­duce hos­pi­tal read­mis­sions by over a third, with pa­tient ad­her­ence lev­els of over 90%.

Hi­tachi Ven­tures led the round along with Leaps by Bay­er, and new share­hold­ers in­clude Sam­sung Next, Sony In­no­va­tion Fund by IGV, Unilever Ven­tures, HAT Tech­nol­o­gy & In­no­va­tion Fund, Nikesh Aro­ra (for­mer pres­i­dent of Soft­Bank) and Michael Diek­mann (chair­man of Al­lianz).

Hu­ma isn’t the on­ly tech de­vel­op­er at­tract­ing in­vestors with its de­cen­tral­ized tri­al ap­proach. Last week, Sci­ence 37 land­ed uni­corn sta­tus when it agreed to a SPAC merg­er with LifeSci Ac­qui­si­tion II Corp. Ac­cord­ing to a re­port Sci­ence 37 con­duct­ed it­self, CEO David Co­man said more than 80% of bio­phar­ma com­pa­nies plan on con­duct­ing a clin­i­cal tri­al us­ing at least some de­cen­tral­ized el­e­ments this year, though near­ly 60% don’t have the in­ter­nal ca­pa­bil­i­ties to do it.

Back in Feb­ru­ary, Dublin-based CRO Icon struck a deal to ac­quire PRA Health Sci­ences for $12 bil­lion to fo­cus on de­cen­tral­ized tri­als — a move which would com­bine the 5th- and 6th-largest CROs by 2020 rev­enue. Last month, Ther­mo Fish­er an­nounced plans to ac­quire PPD — a CRO that boasts de­cen­tral­ized tri­al ca­pa­bil­i­ties — for $17.4 bil­lion. And back in No­vem­ber, soft­ware provider Med­able bagged a $91 mil­lion Se­ries C to build out its vir­tu­al tri­al plat­form.

“The pan­dem­ic has ex­posed weak­ness­es across health sys­tems around the world but through col­lab­o­ra­tion, in­no­va­tion, and com­pas­sion­ate lead­er­ship Hu­ma can sup­port faster and safer care for pa­tients through dig­i­tal tech­nolo­gies and rapid ac­cess to treat­ments by ac­cel­er­at­ing clin­i­cal re­search,” Hu­ma’s board di­rec­tor Clau­dia Suess­muth Dy­ck­er­hoff said in a state­ment.

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.

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another week, another horde of biotechs is doing the Nasdaq dance.

This week saw four companies file their SEC paperwork ahead of expected debuts, another hit Nasdaq on Friday and a sixth formally withdrew its bid to go public. Aerovate Therapeutics, Ocean Biomedical and Acumen Pharmaceuticals all penciled in initial raises of $100 million, while Dermata Therapeutics is estimating a modest $18 million raise.

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Keiichi Fukuda, Heartseed CEO

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ap­proach to treat­ing heart fail­ure

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

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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