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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.