Benjamine Liu, TrialSpark CEO

Af­ter years of run­ning tri­als for oth­er drug­mak­ers, Tri­alSpark is build­ing its own pipeline

Tri­alSpark, one of sev­er­al com­pa­nies launched specif­i­cal­ly to ad­dress the “mourn­ful” cost of clin­i­cal de­vel­op­ment, now has $156 mil­lion more to work with — and with it, CEO Ben­jamine Liu has big plans to move in­to drug de­vel­op­ment.

Lin­hao Zhang

The biotech uni­corn — val­ued at more than $1 bil­lion — un­veiled a hefty Se­ries C round on Thurs­day, led by tech in­vestors Sam Alt­man and Lachy Groom. Liu says he’ll use those funds to build a pipeline, ei­ther by ac­quir­ing or part­ner­ing on as­sets. The rest will go to­ward ex­pand­ing the New York-based team, and in­vest­ing in oth­er com­pa­nies with promis­ing can­di­dates.

The goal is to build a “tech com­pa­ny that’s do­ing bio­phar­ma, not a bio­phar­ma com­pa­ny do­ing tech,” Alt­man told Bloomberg. 

Tri­alSpark was launched in 2016 by Liu, a Yale and Ox­ford-trained com­pu­ta­tion­al bi­ol­o­gist, and CTO Lin­hao Zhang, a Sales­force and Os­car Health vet­er­an. A JA­MA study de­ter­mined that around that time, the me­di­an cost of a clin­i­cal tri­al was around $19 mil­lion, with the prici­est tri­als cost­ing as much as $345 mil­lion.

Since its launch, Tri­alSpark has built a clin­i­cal tri­al plat­form that us­es soft­ware to help tri­al sites man­age stud­ies and col­lect da­ta. In 2019, the com­pa­ny joined forces with 23andMe, in the hopes of us­ing its ex­ten­sive data­base and re­search plat­form to speed up the pa­tient re­cruit­ment process.

“Tri­alSpark has al­ready made sig­nif­i­cant ef­forts to­ward ex­pand­ing ac­cess to clin­i­cal tri­als by cre­at­ing sites where pa­tients live and with doc­tors they al­ready see. With 23andMe we can em­pow­er even more pa­tients to ac­cess clin­i­cal tri­als at their lo­cal doc­tor’s of­fice,” Liu said at the time, adding that some da­ta and end­points could be cap­tured with wear­able tech­nol­o­gy, dig­i­tal ther­a­peu­tics, or at-home ge­net­ic test­ing with 23andMe.

The com­pa­ny claims it can en­roll pa­tients near­ly twice as fast as tra­di­tion­al ap­proach­es, and shrink de­vel­op­ment time­lines by 50%.

Michael Moritz

While it re­mains un­clear what tar­gets Tri­alSpark is look­ing to pur­sue in-house, the com­pa­ny says it has an eye for can­di­dates that would “sit on shelves due to the pro­hib­i­tive cost and du­ra­tion of tra­di­tion­al clin­i­cal tri­als.”

A slate of new and old in­vestors chipped in­to the lat­est round, in­clud­ing Se­quoia Cap­i­tal, Thrive Cap­i­tal, Cas­din Cap­i­tal, Drag­oneer, Sec­tion 32, John Do­err, Spark Cap­i­tal, Fe­li­cis Ven­tures, Sound Ven­tures and Ar­row­mark, among oth­er un­named in­vestors.

“When we first met, Ben­jamine was clear about the jour­ney he want­ed to em­bark up­on,” Se­quoia Cap­i­tal’s Michael Moritz said in a state­ment. “Noth­ing has changed. Tri­alSpark has scaled the foothills and the as­sault on the sum­mit has be­gun.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.