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.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.