Test re­sults in hand, Thrive rais­es $257M to push liq­uid biop­sy to­ward ap­proval

Three months af­ter an­nounc­ing the re­sults of a land­mark tri­al, Thrive Ear­li­er De­tec­tion has raised $257 mil­lion to put their liq­uid biop­sy can­cer test in­to a piv­otal tri­al.

Thrive start­ed rais­ing for the Se­ries B im­me­di­ate­ly af­ter the study re­sults were pub­lished in Sci­ence at the end of April. That study, run across 10,000 women at the Geisinger Health Sys­tem, showed for the first time that a blood test could help doc­tors di­ag­nose cer­tain types of can­cer in pa­tients who did not yet show symp­toms, more than dou­bling the per­cent­age of can­cers that were de­tect­ed.

Isaac Ro

“We want­ed that da­ta in hand as a big cat­a­lyst to dri­ve the process,” Thrive CFO Isaac Ro told End­points. 

The round, led by Cas­din Cap­i­tal and Sec­tion 32, will go in­to com­plet­ing de­vel­op­ment of that test this year, so it can then go in­to a piv­otal tri­al — which would like­ly make it the first liq­uid biop­sy test to do so. Thrive, though, is so far qui­et on de­tails, say­ing they’re still wait­ing to hear from the FDA what the stan­dards will be for ap­proval. The com­pa­ny will al­so use funds to be­gin lay­ing the ground­work for com­mer­cial­iza­tion.

“The clin­i­cal tri­al piece is not triv­ial, it’s go­ing to be a clin­i­cal un­der­tak­ing,” Ro said. “It’s one of the rea­sons we raised how much we raised.”

Still, the round, though large, pales in com­par­i­son to the vast cap­i­tal Thrive’s lead­ing com­peti­tor, Grail, has raised in re­cent years. Backed most promi­nent­ly by ARCH, that biotech has raised $2 bil­lion since it was spun out of Il­lu­mi­na, in­clud­ing a $390 mil­lion Se­ries D in the spring, al­though they re­main be­hind Thrive in de­vel­op­ment. By con­trast, Thrive, launched last May, had raised its $110 mil­lion Se­ries A this year.

David J Daly

With­out in­vok­ing Grail specif­i­cal­ly, Ro told End­points that Thrive would be “one of the most cap­i­tal-ef­fi­cient com­pa­nies out there.” More broad­ly, he ar­gued that ul­ti­mate­ly the field would have mul­ti­ple win­ners, with the smat­ter­ing of star­tups now at work nar­row­ing in­to a few. “It’s go­ing to be high­ly un­like­ly that this is go­ing to be a win­ner-take-all mar­ket,” he said.

The field has come a long way since Ther­a­nos made liq­uid biop­sy in­fa­mous — Ro said no in­vestors men­tioned the fall­en uni­corn — but out­side ex­perts cau­tion it still has a ways to go. The tests, in many ways, face the same set of hur­dles as the ear­ly Covid-19 an­ti­body tests: How do you make it sen­si­tive enough that it picks up the scant bi­o­log­i­cal traces of ear­ly ma­lig­nan­cy, while al­so be­ing spe­cif­ic enough that false pos­i­tives are at a tol­er­a­ble min­i­mum? It’s nev­er great to in­cor­rect­ly tell a per­son they have can­cer.

Thrive may like­ly have to prove it can do both in its up­com­ing tri­al to win ap­proval. The scant de­tails they dis­closed from the study plans in­clude that, un­like the first tri­al, it will be across nu­mer­ous hos­pi­tal sys­tems and it will in­clude men.

Grail, mean­while, is now con­duct­ing a study sim­i­lar to the one Thrive pub­lished in April. The two biotechs use dif­fer­ent tech­nolo­gies. Grail looks for slight changes to cir­cu­lar pieces of DNA in the blood, while Thrive looks for changes to par­tic­u­lar genes and a hand­ful of pro­teins.

CEO David Daly said he’s hap­py to see the com­pe­ti­tion.

“We ac­tu­al­ly wel­come the in­vest­ment that oth­ers are mak­ing,” Daly told End­points. “With so much fo­cus and re­sources go­ing in­to ear­ly de­tec­tion, it’s an ex­cit­ing time.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).