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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Viswa Colluru, Enveda Biosciences

A Re­cur­sion vet­er­an is map­ping plant life to chart a course to new ther­a­pies — and in­vestors like what they see

One of the earliest employees at AI biotech Recursion Pharmaceuticals is leading a new company, and he’s just closed a hefty Series A to get things moving.

Enveda Biosciences pulled in $51 million in the raise, the company announced Tuesday morning, with the goal of pushing some of its preclinical programs further along. Led by CEO Viswa Colluru, Enveda aims to research how machine learning can utilize natural biology to create new therapies for Wilson’s Disease, NASH and Parkinson’s disease, among others.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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