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.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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