Test re­sults in hand, Thrive rais­es $257M to push liq­uid biop­sy to­ward ap­proval

Three months af­ter an­nounc­ing the re­sults of a land­mark tri­al, Thrive Ear­li­er De­tec­tion has raised $257 mil­lion to put their liq­uid biop­sy can­cer test in­to a piv­otal tri­al.

Thrive start­ed rais­ing for the Se­ries B im­me­di­ate­ly af­ter the study re­sults were pub­lished in Sci­ence at the end of April. That study, run across 10,000 women at the Geisinger Health Sys­tem, showed for the first time that a blood test could help doc­tors di­ag­nose cer­tain types of can­cer in pa­tients who did not yet show symp­toms, more than dou­bling the per­cent­age of can­cers that were de­tect­ed.

Isaac Ro

“We want­ed that da­ta in hand as a big cat­a­lyst to dri­ve the process,” Thrive CFO Isaac Ro told End­points. 

The round, led by Cas­din Cap­i­tal and Sec­tion 32, will go in­to com­plet­ing de­vel­op­ment of that test this year, so it can then go in­to a piv­otal tri­al — which would like­ly make it the first liq­uid biop­sy test to do so. Thrive, though, is so far qui­et on de­tails, say­ing they’re still wait­ing to hear from the FDA what the stan­dards will be for ap­proval. The com­pa­ny will al­so use funds to be­gin lay­ing the ground­work for com­mer­cial­iza­tion.

“The clin­i­cal tri­al piece is not triv­ial, it’s go­ing to be a clin­i­cal un­der­tak­ing,” Ro said. “It’s one of the rea­sons we raised how much we raised.”

Still, the round, though large, pales in com­par­i­son to the vast cap­i­tal Thrive’s lead­ing com­peti­tor, Grail, has raised in re­cent years. Backed most promi­nent­ly by ARCH, that biotech has raised $2 bil­lion since it was spun out of Il­lu­mi­na, in­clud­ing a $390 mil­lion Se­ries D in the spring, al­though they re­main be­hind Thrive in de­vel­op­ment. By con­trast, Thrive, launched last May, had raised its $110 mil­lion Se­ries A this year.

David J Daly

With­out in­vok­ing Grail specif­i­cal­ly, Ro told End­points that Thrive would be “one of the most cap­i­tal-ef­fi­cient com­pa­nies out there.” More broad­ly, he ar­gued that ul­ti­mate­ly the field would have mul­ti­ple win­ners, with the smat­ter­ing of star­tups now at work nar­row­ing in­to a few. “It’s go­ing to be high­ly un­like­ly that this is go­ing to be a win­ner-take-all mar­ket,” he said.

The field has come a long way since Ther­a­nos made liq­uid biop­sy in­fa­mous — Ro said no in­vestors men­tioned the fall­en uni­corn — but out­side ex­perts cau­tion it still has a ways to go. The tests, in many ways, face the same set of hur­dles as the ear­ly Covid-19 an­ti­body tests: How do you make it sen­si­tive enough that it picks up the scant bi­o­log­i­cal traces of ear­ly ma­lig­nan­cy, while al­so be­ing spe­cif­ic enough that false pos­i­tives are at a tol­er­a­ble min­i­mum? It’s nev­er great to in­cor­rect­ly tell a per­son they have can­cer.

Thrive may like­ly have to prove it can do both in its up­com­ing tri­al to win ap­proval. The scant de­tails they dis­closed from the study plans in­clude that, un­like the first tri­al, it will be across nu­mer­ous hos­pi­tal sys­tems and it will in­clude men.

Grail, mean­while, is now con­duct­ing a study sim­i­lar to the one Thrive pub­lished in April. The two biotechs use dif­fer­ent tech­nolo­gies. Grail looks for slight changes to cir­cu­lar pieces of DNA in the blood, while Thrive looks for changes to par­tic­u­lar genes and a hand­ful of pro­teins.

CEO David Daly said he’s hap­py to see the com­pe­ti­tion.

“We ac­tu­al­ly wel­come the in­vest­ment that oth­ers are mak­ing,” Daly told End­points. “With so much fo­cus and re­sources go­ing in­to ear­ly de­tec­tion, it’s an ex­cit­ing time.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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