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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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