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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Several months after emerging from what CEO Raju Mohan called “quiet mode” with a mammoth $114 million raise, Ventyx Biosciences is now making its plans for the clinic loud and clear.

The California-based immune modulation player kicked the week off with a $51 million Series B, while also naming some key hires ahead of its big clinical push.

The CMO slot is going to Jörn Drappa, former CMO at Viela Bio before it was bought out by Horizon Therapeutics earlier this year. The AstraZeneca vet stayed on at Horizon for a while as executive VP of R&D before making the jump to Ventyx.