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.”

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.