Can­cer is the sec­ond lead­ing cause of death glob­al­ly — the ear­li­er it is de­tect­ed, the bet­ter shot pa­tients have of bounc­ing back. Re­searchers have long pur­sued a min­i­mal­ly-in­va­sive, ef­fec­tive test to ex­pose ear­ly mark­ers of the of­ten dead­ly dis­ease, and weeks ago Grail blue­print­ed its strat­e­gy for its blood test for ear­ly can­cer de­tec­tion. On Thurs­day, Third Rock Ven­tures un­veiled its shot at that lofty goal, with the launch of a liq­uid biop­sy com­pa­ny that has raised a meaty $110 mil­lion in its first round.

The com­pa­ny, apt­ly named Thrive Ear­li­er De­tec­tion, is bet­ting on Can­cerSEEK — its blood test-in-de­vel­op­ment de­signed to sniff out eight com­mon can­cer types by in­ter­ro­gat­ing ge­nom­ic mu­ta­tions in cir­cu­lat­ing tu­mor DNA (ctD­NA) as well as pro­tein mark­ers in plas­ma that have been im­pli­cat­ed in can­cer.

“It’s great to be part of an area, where (…) we could do for can­cer what 50 years ago we did for heart dis­ease, when we start­ed screen­ing for high blood pres­sure for ex­am­ple,” said Steven Kaf­ka, Thrive CEO and part­ner at Third Rock Ven­tures, in an in­ter­view with End­points News ahead of the an­nounce­ment.

Can­cerSEEK is en­gi­neered to not on­ly be pow­ered to iden­ti­fy the pres­ence of rel­a­tive­ly ear­ly can­cer, but us­es ma­chine learn­ing to lo­cal­ize the or­gan of ori­gin of the can­cer — even­tu­al­ly, the hope is the test will be used as part of the ar­se­nal of rou­tine med­ical screen­ing tools, to com­ple­ment ex­ist­ing dis­ease-spe­cif­ic screen­ing meth­ods such as mam­mog­ra­phy and colonoscopy.

In a ret­ro­spec­tive study, en­com­pass­ing 1,005 pa­tients with non-metasta­t­ic, clin­i­cal­ly de­tect­ed can­cers of the ovary, liv­er, stom­ach, pan­creas, esoph­a­gus, col­orec­tum, lung, or breast pub­lished in the jour­nal Sci­ence last year, Can­cerSEEK tests were pos­i­tive in a me­di­an of 70% of the eight can­cer types.

Da­ta showed the sen­si­tiv­i­ty of the test ranged from 69% to 98% for the de­tec­tion of five can­cer types — ovary, liv­er, stom­ach, pan­creas, and esoph­a­gus — for which there are no screen­ing tests avail­able for av­er­age-risk in­di­vid­u­als. Mean­while, the abil­i­ty of the test to hone in on the or­gan of can­cer ori­gin was > 99% — al­though 7 out of 812 healthy con­trols scored pos­i­tive. In ad­di­tion, Can­cerSEEK lo­cal­ized the can­cer to a small num­ber of anatom­ic sites in a me­di­an of 83% of the pa­tients.

Af­ter da­ta from the Can­cerSEEK study was pub­lished, Sci­ence writer Derek Lowe sug­gest­ed there was room for im­prove­ment, but it con­sti­tut­ed a good start. “The big­ger prob­lem is if you’re go­ing to use this test for ear­ly de­tec­tion: when the team looked at the de­tec­tion rates ad­just­ed for the stage of the di­ag­nosed tu­mors, Can­cerSEEK turned out to on­ly catch 43% of the Stage I cas­es over­all,” he wrote in a post.

Im­age: Bert Vo­gel­stein THRIVE

Can­cerSEEK has been grant­ed the FDA’s break­through de­vice sta­tus, as has Grail’s mul­ti-can­cer de­tec­tion blood test, which re­lies on DNA se­quenc­ing to as­sess methy­la­tion, an epi­ge­net­ic change across the genome to ex­pose can­cer sig­nals.

Ken­neth Kin­zler Johns Hop­kins

Grail, which was spun out of DNA se­quenc­ing com­pa­ny Il­lu­mi­na $ILMN in 2016, has raised $1.6 bil­lion in fund­ing to fu­el the de­vel­op­ment of its test, which is now be­ing eval­u­at­ed in three large-scale stud­ies that will al­to­geth­er en­roll 165,000 in­di­vid­u­als.

Nick­o­las Pa­padopou­los Johns Hop­kins

Thrive — which was found­ed by three can­cer re­searchers Bert Vo­gel­stein, Ken­neth Kin­zler and Nick­o­las Pa­padopou­los at Johns Hop­kins Uni­ver­si­ty — is al­so eval­u­at­ing Can­cerSEEK in a large prospec­tive study. The tri­al, called DE­TECT, has en­rolled 10,000 healthy women aged be­tween 65 and 75 with­out pri­or can­cer his­to­ry.

Da­ta from DE­TECT should be avail­able some­time next year, Kaf­ka said.

“We have a goal of it (Can­cerSEEK) be­ing in the hun­dreds of dol­lars, com­mer­cial­ly, not thou­sands of dol­lars… sin­gle dis­ease tests like (Ex­act Sci­ence’s) Co­lo­guard are list priced at $600 or $700, a mam­mog­ra­phy costs $100 to $200 and if you think of those as the guard rail — we have a mul­ti can­cer test that al­ready we be­lieve is per­form­ing with­in that lev­el of cost.” he added.

Third Rock Ven­tures led the $110 mil­lion Se­ries A fi­nanc­ing, with par­tic­i­pa­tion from Sec­tion32, Cas­din Cap­i­tal, Bio­mat­ics Cap­i­tal, Blue­Cross BlueShield Ven­ture Part­ners, The In­vus Group, Ex­act Sci­ences $EXAS, Cowin Ven­ture, Cam­den Part­ners, Gam­ma 3 LLC and oth­ers.

Oth­er com­pa­nies such as Guardant Health and Bio­cept are al­so work­ing on their own liq­uid biop­sy tests. Each com­pa­ny is look­ing to cham­pi­on con­sis­ten­cy and ac­cu­ra­cy — false pos­i­tives in­duce un­nec­es­sary anx­i­ety, and are cost­ly. An­oth­er con­cern is of course, pri­va­cy.

Im­age: Steven Kaf­ka THRIVE

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.