Ed Tourtellotte (CTO) and David Kelleher (CEO), 4G Clinical

Gold­man Sachs backs clin­i­cal tri­al ser­vices in the cloud with $230M eq­ui­ty play amid de­cen­tral­ized study craze

The fo­cus on de­cen­tral­ized clin­i­cal tri­als dur­ing the Covid-19 pan­dem­ic has shak­en up the con­tract re­search space and spurred some mas­sive val­u­a­tions and deals along the way. Now, a com­pa­ny work­ing in cloud-based tri­al ser­vices on the cut­ting edge of the field has snared a ma­jor in­vest­ment from a lead­ing Wall Street banker.

4G Clin­i­cal, a ser­vices firm that pro­vides cloud-based ran­dom­iza­tion and clin­i­cal tri­al ser­vices, has bagged a $230 mil­lion eq­ui­ty in­vest­ment from Gold­man Sachs as it looks to add jet fu­el to its glob­al ex­pan­sion plans, the com­pa­ny said in a re­lease.

4G’s been around for six years and has so far run tri­al ser­vices for around 100 clin­i­cal stud­ies for bio­phar­ma com­pa­nies, the firm said. The com­pa­ny’s plat­form can cut the time for first pa­tient en­roll­ment by 50%, it said, and is de­signed for in­creas­ing­ly com­plex tri­al de­sign, in­clud­ing de­cen­tral­ized stud­ies.

“As life sci­ences com­pa­nies strive for cre­ativ­i­ty and in­no­va­tion in tri­al de­signs, they can­not af­ford to be lim­it­ed by tech­nol­o­gy,” said 4G CTO Ed Tourtel­lotte said in a state­ment.

Gold­man Sachs’ in­vest­ment comes amid a spike in in­ter­est in com­pa­nies and ser­vices work­ing in de­cen­tral­ized clin­i­cal tri­als, a field that has seen rapid growth amid Covid-19.

In May, vir­tu­al tri­al soft­ware com­pa­ny Sci­ence 37 went pub­lic as part of a re­verse merg­er with LifeSci Ac­qui­si­tion II Corp that val­ued the com­pa­ny at $1.05 bil­lion. Sci­ence 37 got its start back in 2014 and struck a part­ner­ship with No­var­tis four years lat­er to launch 10 vir­tu­al clin­i­cal tri­als in which pa­tients could par­tic­i­pate via cell phone. The sys­tem can cap­ture and gen­er­ate da­ta from things like elec­tron­ic clin­i­cal out­comes as­sess­ments, eCon­sent and re­al-world ev­i­dence.

Mean­while, com­pa­nies like Lon­don-based Hu­ma are us­ing wear­able tech­nol­o­gy and a pa­tient app to help 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%. In May, the firm un­veiled a $130 mil­lion Se­ries C with back­ing from Leaps by Bay­er.

Mean­while, the rush in­to de­cen­tral­ized tri­als has al­so spurred a wave of M&A among the ma­jor con­tract re­search out­fits. In April, Ther­mo Fish­er ac­quired PPD for $17.4 bil­lion, ex­plic­it­ly paint­ing the deal as a boost to its tri­al ser­vices wing.

Two months ear­li­er, Dublin-based Icon bagged PRA Health Sci­ences for $12 bil­lion, a merg­er that cre­at­ed the sec­ond-largest glob­al CRO be­hind on­ly IQVIA in terms of 2020 rev­enue. PRA not­ed in its an­nounce­ment the growth in de­cen­tral­ized tri­als the pan­dem­ic has fu­eled.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

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

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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