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.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.