Hans Bishop, Grail CEO (Victor J. Blue/Bloomberg via Getty Images)

Blood test for can­cer de­tec­tion com­pa­ny Grail rakes in $390M in lat­est round

Just over a week af­ter Third Rock-backed Thrive un­veiled ‘re­al world’ da­ta from a large study eval­u­at­ing the abil­i­ty of its blood test to sniff out ear­ly signs of can­cer in in­di­vid­u­als with no his­to­ry of the dis­ease, ri­val Grail has raised a gar­gan­tu­an $390 mil­lion in its lat­est round of fi­nanc­ing.

Grail — which was carved out of the DNA se­quenc­ing com­pa­ny Il­lu­mi­na in 2016 — has a mul­ti-can­cer de­tec­tion blood test that re­lies on DNA se­quenc­ing to as­sess methy­la­tion, an epi­ge­net­ic change across the genome to ex­pose can­cer sig­nals.

Akin to Thrive’s near­ly 10,000-strong DE­TECT-A study, Grail is cur­rent­ly en­rolling pa­tients (with the aim of re­cruit­ing 6,200) in a prospec­tive PATHFIND­ER tri­al, which is de­signed to as­sess the util­i­ty of its ear­ly de­tec­tion blood test in clin­i­cal prac­tice. Grail is al­so en­rolling an ob­ser­va­tion­al lon­gi­tu­di­nal, co­hort study chris­tened SUM­MIT in Lon­don with 50,000 peo­ple who do not have a can­cer di­ag­no­sis at the time of en­roll­ment, but half of whom are smok­ers at high risk of can­cer.

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.

While Grail, backed by ARCH Ven­ture Part­ners, re­lies on methy­la­tion to en­gi­neer its blood test de­signed to de­tect up to 50 can­cer types, Thrive Ear­li­er De­tec­tion is bet­ting on in­ter­ro­gat­ing ge­nom­ic mu­ta­tions in cir­cu­lat­ing tu­mor DNA (ctD­NA) as well as pro­tein mark­ers in plas­ma that have been im­pli­cat­ed in can­cer, to sniff out eight com­mon can­cer types. Both com­pa­nies have se­cured the FDA’s break­through ther­a­py sta­tus for their prod­ucts.

There is a smat­ter­ing of oth­er com­pa­nies such as Guardant Health, Bio­cept and Sav­i­cell with the same aim, some of whom are lean­ing on oth­er mark­ers to de­vel­op their 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.

This $390 mil­lion Se­ries D fi­nanc­ing round, an­nounced on Wednes­day, brought in new in­vestors in­clud­ing Pub­lic Sec­tor Pen­sion In­vest­ment Board and Cana­da Pen­sion Plan In­vest­ment Board, as well as two undis­closed in­vestors, who were joined by ex­ist­ing back­ers such as Il­lu­mi­na. Al­to­geth­er, since 2016, Grail has raised more than $1.9 bil­lion in four rounds of eq­ui­ty fi­nanc­ing.

“Near­ly 80 per­cent of can­cer deaths re­sult from can­cers for which there is no screen­ing test to­day, and GRAIL’s mis­sion is to change that through the ear­ly de­tec­tion and lo­cal­iza­tion of more than 50 can­cers,” said com­pa­ny chief Hans Bish­op in a state­ment. “En­abling this through a sin­gle blood draw could im­prove pa­tient ac­cess and ad­her­ence to can­cer screen­ing and ad­dress dis­par­i­ties in can­cer care by im­prov­ing ac­cess for rur­al, vul­ner­a­ble, and un­der-served pop­u­la­tions.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.