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

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.