Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

Soft­Bank has found its newest biotech in­vest­ment.

The Japan­ese bank has in­vest­ed $165 mil­lion in­to Kar­ius, a com­pa­ny that us­es blood tests to di­ag­nose in­fec­tious dis­eases, as part of its new Vi­sion Fund 2. The full scope of the new fund has yet to be an­nounced, but the first and new­ly-be­lea­guered Vi­sion Fund poured $100 bil­lion in­to tech­nol­o­gy com­pa­nies, in­clud­ing the biotechs Vir Biotech­nol­o­gy and Roivant and the se­quenc­ing com­pa­ny 10x Ge­nomics.

Based in San Fran­cis­co, Kar­ius de­vel­ops tests that can be used to rapid­ly di­ag­nose pa­tients with any one of over 1,000 in­fec­tious dis­eases. The idea is to by­pass the rel­a­tive­ly slow guess-and-check sys­tem where­by doc­tors hy­poth­e­size if a pa­tient’s symp­toms match a dis­ease and then test for it, and in­stead di­rect­ly test the blood for mark­ers that will in­di­cate if a cer­tain dis­ease is present.

It launched out of stealth mode in 2017 with $50 mil­lion in fund­ing and some me­dia-friend­ly anec­dotes. That in­clud­ed a 3-year-old boy whose rash stumped doc­tors as test af­ter test came back neg­a­tive un­til sam­ples were shipped to Kar­ius’ labs. Overnight, they showed he had rat-bite fever, and had like­ly been scratched by his pet rat.

Kar­ius us­es a tech­nol­o­gy called cell-free DNA tests. They an­a­lyze the strands of DNA that float freely in your blood, giv­en off by dy­ing cells. If you have an in­fec­tion, that stream of free-float­ing DNA may con­tain frag­ments of DNA from the bac­te­ria or virus­es that caused the in­fec­tion. Iden­ti­fy the source of the DNA — as re­cent ad­vances in re­duc­tion tech­nol­o­gy and ar­ti­fi­cial in­tel­li­gence have al­lowed re­searchers to do — iden­ti­fy the in­fec­tion.

Physi­cians have called cell-free DNA tests a “mol­e­c­u­lar stetho­scope,” com­par­ing the changes it might bring to di­ag­no­sis to the changes her­ald­ed by the acoustic stetho­scope in the 1800s. The first us­es of such analy­ses came in 2011, when it was first used to test the blood of preg­nant women for fe­tal DNA that in­di­cat­ed a fe­tus with Down syn­drome. Mick­ey Kertesz, now CEO of Kar­ius, and a Stan­ford team no­ticed DNA from in­fec­tious dis­eases in the blood­stream and start­ed plot­ting ways to test it sys­tem­at­i­cal­ly.

A big val­i­da­tion for Kar­ius’s tech­nol­o­gy came in a small JA­MA study pub­lished in De­cem­ber. Re­searchers took 47 pa­tients at St. Jude Chil­dren’s Re­search Hos­pi­tal and test­ed them for blood­stream in­fec­tion, a po­ten­tial­ly life-threat­en­ing com­pli­ca­tion of cer­tain can­cer treat­ment. Of the 16 pa­tients who even­tu­al­ly showed signs of in­fec­tion, Kar­ius di­ag­noses them at least 3 days be­fore symp­toms ap­peared.

A Na­ture Mi­cro­bi­ol­o­gy study pub­lished last year al­so showed that the Kar­ius test reached the same con­clu­sion as a blood cul­ture analy­sis in 93.7% of sep­sis cas­es across 350 stu­dents.  Ad­di­tion­al­ly, there is ev­i­dence that it can be used as a less in­va­sive way to screen for or­gan trans­plant match­es.

Kar­ius said that its test is now used in over 100 hos­pi­tals and health sys­tems na­tion­wide, but it doesn’t come cheap: $2,000 per test.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Gerry Brunk (Lumira)

What will Lu­mi­ra Ven­tures do with $220M? Stay out of the com­fort zone and off the beat­en biotech path

Lumira Ventures closed its largest fund on Monday, raking in $220 million to pump into the life sciences — but instead of targeting biotech hubs like San Francisco and Boston, the company is rolling the dice on “underserved geographies” in the US and Canada.

“We find oftentimes companies located in places like Montreal, or Fort Lauderdale, FL, or Kansas City or Phoenix, AZ just have more capital efficiency and better valuations, without having to compromise anything at all in the quality of the innovation and the management talent,” co-founder and managing partner Gerry Brunk told Endpoints News.