Third Rock un­veils liq­uid biop­sy biotech, lead­ing $110M bet it can Thrive in ear­ly can­cer de­tec­tion

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

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.