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.”

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Shortly after Sirnaomics brought in a $47 million Series C for its small interfering RNA pipeline last year, Patrick Lu — the founder, president and CEO — was asked to outline the scientific advances that will be necessary to make better drugs out of RNA tech.

“The next step in the evolution of RNAi as a leading therapeutic will be the ability to safely target organs outside the liver such as lung, brain, etc,” he had offered. “This will revolutionize disease treatments if the industry can demonstrate similar data sets for non-liver targets as we have seen in liver-based diseases.”