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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”