Michelle Longmire, Medable CEO (Photo Credit: Jeff Rumans)

Med­able trots its way to uni­corn sta­tus amid vir­tu­al tri­al craze. Is a pub­lic de­but next?

As it be­comes ap­par­ent that de­cen­tral­ized clin­i­cal tri­als will like­ly be a part of drug­mak­ers’ strate­gies long af­ter the pan­dem­ic is over, a tech de­vel­op­er is gal­lop­ing its way to uni­corn sta­tus with a $304 mil­lion megaround.

Med­able un­veiled a hefty Se­ries D round on Tues­day — its fourth in the last year and a half — led by Black­stone Growth, Tiger Glob­al and GSR Ven­tures. The new cash brings the Pa­lo Al­to-based com­pa­ny’s to­tal raise to $521 mil­lion, with a whop­ping $2.1 bil­lion val­u­a­tion.

The team will use these funds to tack­le long­stand­ing “bar­ri­ers to drug de­vel­op­ment,” in­clud­ing a lack of di­ver­si­ty in clin­i­cal tri­als, the time it takes to con­duct a large study, and a lack of aware­ness for tri­als them­selves.

San­skri­ti Thakur

“We are not mak­ing med­i­cine for every­body,” chief growth of­fi­cer San­skri­ti Thakur told End­points News. “The re­al­i­ty is on­ly 2 to 3% of the pop­u­la­tion who are ap­pro­pri­ate for sci­en­tif­ic re­search ever get ac­cess to it.”

The num­bers are even more stark for com­mu­ni­ties of col­or. Of the 53 drugs ap­proved this past year, Black pa­tients rep­re­sent­ed about 8% of par­tic­i­pants in the tri­als reg­u­la­tors based their de­ci­sions on (and for which da­ta on race was col­lect­ed), de­spite rep­re­sent­ing about 13% of the US pop­u­la­tion. Lat­inX par­tic­i­pants rep­re­sent­ed just un­der 13% of stud­ies.

Med­able be­lieves its plat­form can be used to re­cruit more di­verse pa­tient pop­u­la­tions faster — and re­tain them. It’s the type of tech­nol­o­gy that al­lows vol­un­teers to pick up a phone to par­tic­i­pate in a tri­al, rather than vis­it­ing a clin­ic, which may be far away, or op­er­at­ing un­der re­stric­tions amid the pan­dem­ic.

“De­cen­tral­ized tri­al tech­nolo­gies have been crit­i­cal to drug de­vel­op­ment dur­ing the pan­dem­ic, pro­vid­ing glob­al re­mote ac­cess and sup­port­ing COVID vac­cine and ther­a­peu­tic re­search at record speed,” CEO and co-founder Michelle Long­mire said in a state­ment. “Pa­tients need the life sci­ences in­dus­try to con­tin­ue in­no­vat­ing at this pace.

Since launch­ing in 2012 and then se­cur­ing its first cus­tomer in 2016, Med­able has de­ployed its soft­ware in more than 150 de­cen­tral­ized and hy­brid tri­als in 60 coun­tries. As ex­pect­ed, the busi­ness saw a big boost amid the pan­dem­ic, an­nounc­ing last year that its rev­enue had soared more than 500%.

Now that it’s had the time to look at the da­ta from those tri­als, Med­able claims its plat­form helped achieve 200% faster en­roll­ment rates, 90% re­ten­tion rates, and 50% cost re­duc­tions.

Last year, the com­pa­ny launched three new ap­pli­ca­tions: Tele­Vis­it, which con­nects pa­tients with site co­or­di­na­tors and in­ves­ti­ga­tors; Tele­Con­sent, which al­lows pa­tients to vir­tu­al­ly con­sent and re-con­sent to clin­i­cal tri­als; and Tele­COA, which com­bines elec­tron­ic Clin­i­cal Out­come As­sess­ments (eCOAs) with Tele­Vis­its. It al­so struck part­ner­ships with Data­vant, AliveCor and MRN.

When asked if an IPO is on the hori­zon, Thakur re­spond­ed: “We will fund our­selves in or­der to achieve our mis­sion. And I think that we have to re­al­ly con­sid­er what the right struc­ture is for us.”

Med­able is far from alone in this space. Sci­ence 37 took its first stroll down Wall Street just last month when it com­plet­ed a $235 mil­lion SPAC merg­er with LifeSci Ac­qui­si­tion II Corp. Parex­el, a CRO with vir­tu­al tri­al abil­i­ties, was snapped up by Gold­man Sachs’ pri­vate eq­ui­ty branch and the EQT IX fund for $8.5 bil­lion ear­li­er this year. And those are just a few of the play­ers bet­ting that the fu­ture of clin­i­cal tri­als is vir­tu­al.

“It’s im­por­tant that we rec­og­nize that the whole in­dus­try is at a de­ci­sion point,” Thakur said.

Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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