Jeff Elton, ConcertAI CEO (via MassBio)

Con­cer­tAI sings a uni­corn tune as the FDA-part­nered clin­i­cal tri­als soft­ware up­start ex­pands

The crescen­do is build­ing at Con­cer­tAI as the ar­ti­fi­cial in­tel­li­gence life sci­ences start­up reels in its en­sem­ble to boost clin­i­cal study di­ver­si­ty, ex­pand de­cen­tral­ized clin­i­cal tri­als and pile on the re­al-world da­ta for can­cer treat­ments.

The FDA-part­nered up­start raised a $150 mil­lion Se­ries C, soar­ing in­to uni­corn sta­tus to a $1.9 bil­lion val­u­a­tion, to take its tech on a world­wide tour. The cur­rent set list of 45 bio­phar­ma and con­tract re­search or­ga­ni­za­tion cus­tomers is not enough for the five-year-old Cam­bridge, MA, com­pa­ny.

“While we start­ed off as a da­ta-cen­tric or­ga­ni­za­tion, we’ve re­al­ly been ad­vanc­ing as much more of a tech­nol­o­gy-cen­tric or­ga­ni­za­tion,” CEO Jeff El­ton told End­points News. A for­mer Ac­cen­ture glob­al man­ag­ing di­rec­tor and North Amer­i­ca life sci­ences leader, El­ton is a board mem­ber of the Mass­a­chu­setts Biotech­nol­o­gy Coun­cil.

A Bris­tol My­ers Squibb tie-up, an FDA part­ner­ship on re­al-world out­comes of on­col­o­gy treat­ments, an ex­pand­ed mul­ti-year col­lab­o­ra­tion with J&J’s Janssen — to in­crease tri­al di­ver­si­ty and ramp up wider ac­cess to tri­als — and an ac­qui­si­tion of Ter­aRecon, which serves 1,300 clin­i­cal tri­al sites world­wide, were all ma­jor mile­stones in 2021 that paved the route for a ma­jor cap­i­tal haul this year. Ex­pect more deal flow as Con­cer­tAI aims to be a “pos­i­tive, strong ac­quir­er,” El­ton said.

The com­pa­ny brought in new in­vestor Sixth Street be­cause of its soft­ware-as-a-ser­vice and life sci­ences ex­per­tise, El­ton said. One no­table group that Con­cer­tAI hasn’t tar­get­ed for in­vest­ment: bio­phar­mas and di­ag­nos­tics com­pa­nies.

“We’ve re­al­ly tried to main­tain our­selves as neu­tral, and when you’re do­ing work be­tween providers and bio­phar­ma, that neu­tral­i­ty ac­tu­al­ly means trust and that neu­tral­i­ty means you can play a more im­por­tant role as you go for­ward, and that’s not true of a lot of the groups that we tend to see in our ecosys­tem,” El­ton said.

Con­cer­tAI says its soft­ware has been in­volved in about 40 new prod­uct launch­es; in­creased pa­tients’ time on ther­a­py by 10%; and shrunk time for study de­sign and clin­i­cal tri­al ex­e­cu­tion by up to 25%. The 1,000-em­ploy­ee com­pa­ny has been grow­ing on av­er­age “a lit­tle north of 40%” per year, El­ton said.

As the start­up ma­tures, El­ton said Con­cer­tAI will build out its com­mer­cial team while re­main­ing a sci­ence- and clin­i­cal ex­per­tise-led com­pa­ny.

Aside from the FDA, phar­mas and CROs, Con­cer­tAI’s tools are al­so de­ployed at med­ical so­ci­eties and oth­er reg­u­la­tors across Eu­rope and Japan, too. Growth will come in Asia-Pa­cif­ic and Latin Amer­i­ca next, El­ton said. Its tech is used on both piv­otal and post-ap­proval tri­als.

“Over the past two years, we’ve fo­cused on nov­el clin­i­cal re­search so­lu­tions with the po­ten­tial to ac­cel­er­ate the time from study ini­ti­a­tion to reg­u­la­to­ry de­ci­sion, in­creas­ing our over­all in­no­va­tion ca­pac­i­ty. This will al­low us to reach more pa­tients and ac­cel­er­ate life-chang­ing can­cer ther­a­pies to ben­e­fit pa­tients glob­al­ly,” said Marisa Co, VP of R&D busi­ness in­sights and an­a­lyt­ics at Bris­tol My­ers, in the news re­lease.

JPM 2020 was the last time the start­up boast­ed of a fund­ing round, se­cur­ing $150 mil­lion in fi­nanc­ing in the months lead­ing up to the pan­dem­ic. Fol­low­ing the lat­est fi­nanc­ing, in­vestors in­clude Sixth Street, De­c­la­ra­tion Part­ners, Mav­er­ick Ven­tures, Al­liance­Bern­stein PCI, SAIGroup and oth­ers.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Neil Desai, Aadi Bioscience CEO (via YouTube)

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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