David Coman, Science 37

Amid vir­tu­al tri­al craze, Sci­ence 37 earns uni­corn sta­tus and a trip to Nas­daq on the back of SPAC deal

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As the Covid-19 pan­dem­ic made con­ven­tion­al tri­als im­pos­si­ble for some drug­mak­ers, more and more com­pa­nies moved to de­cen­tral­ize their clin­i­cal stud­ies, ac­cel­er­at­ing busi­ness for tech de­vel­op­ers like Sci­ence 37. Lever­ag­ing that boost, the com­pa­ny is on the verge of a SPAC merg­er, land­ing uni­corn sta­tus and its very own stock tick­er.

Sci­ence 37 is set to merge with LifeSci Ac­qui­si­tion II Corp., which raised just over $80 mil­lion in an IPO back in No­vem­ber, it an­nounced on Fri­day. The deal — ex­pect­ed to close in Q3 — will val­ue Sci­ence 37 at $1.05 bil­lion, and set it up for $200 mil­lion in PIPE fund­ing from a slate of in­vestors in­clud­ing Red­mile and Black­Rock.

“While near­ly all tra­di­tion­al sites are back open around the world, our first quar­ter was by far our com­pa­ny’s best, and we see that trend con­tin­u­ing in the fu­ture,” CEO David Co­man told End­points News in an email.

The com­pa­ny 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. It em­ploys the help of not on­ly de­vices, but al­so telemed­i­cine in­ves­ti­ga­tors, mo­bile nurs­es and re­mote co­or­di­na­tors.

Ac­cord­ing to a re­port Sci­ence 37 con­duct­ed it­self, Co­man says more than 80% of bio­phar­ma com­pa­nies plan on con­duct­ing a clin­i­cal tri­al us­ing at least some de­cen­tral­ized el­e­ments this year, and near­ly 60% don’t have the in­ter­nal ca­pa­bil­i­ties to do it.

“Our clin­i­cal tri­al Op­er­at­ing Sys­tem (OS) can en­able sig­nif­i­cant­ly faster en­roll­ment, re­tain pa­tients at a mean­ing­ful­ly high­er rate, and achieve high­er en­roll­ment among di­verse pa­tient pop­u­la­tions—all help­ing to ac­cel­er­ate the de­vel­op­ment of ther­a­pies that im­pact pa­tients’ lives,” he said.

In ad­di­tion to Red­mile and Black­Rock, the PIPE fund­ing al­so in­cludes Cas­din Cap­i­tal, dRx Cap­i­tal, LifeSci Ven­ture Part­ners, Lux Cap­i­tal, Mubadala Cap­i­tal, Per­cep­tive Ad­vi­sors, PPD, Pu­ra Vi­da In­vest­ments, RS In­vest­ments, RTW In­vest­ments, Sam­sara Bio­Cap­i­tal, and Sur­vey­or Cap­i­tal.

The deal al­so in­cludes an­oth­er $125 mil­lion in per­for­mance-based eq­ui­ty con­sid­er­a­tion. The com­pa­ny will list un­der the tick­er $SNCE.

De­cen­tral­ized tri­als have seen mas­sive growth in the last year. 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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

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A flurry of biotechs are expected to hit Nasdaq this week, with two companies, Ambrx Biopharma and Century Therapeutics, setting the terms for their public debuts, with expected raises at $126 million and $200 million, respectively. Alzamend Neuro is also joining in with a $12.5 million raise and two preclinical Alzheimer’s treatments in tow.

Alexander Vos, VectorY CEO

Start­ing fresh in man­u­fac­tur­ing, For­bion start­up re­fu­els to steer next-gen gene ther­a­py ap­proach for ALS, Alzheimer's in­to clin­ic

Forbion laid out its case for a next-generation gene therapy approach when it took the wraps off VectorY Therapeutics and its vectorized antibody tech in February. Now, the Dutch VC has tapped an experienced hand at cell and gene therapy manufacturing to steer the ship — and pulled a marquee syndicate for a €31 million ($37.6 million) seed round.

Alexander Vos, the new CEO, is a venture partner at BioGeneration Ventures and jumps immediately from VarmX, a BGV portfolio company developing an anticoagulant. But before that, he had led Dutch CDMO PharmaCell for eight years until it was bought out by Lonza.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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