Travis May, Datavant CEO

J&J, Cigna back a vant’s quest to go deep­er in­to the da­ta and start con­nect­ing the dots

Data­vant has tapped some un­con­ven­tion­al sources for a $40 mil­lion raise de­signed to take them much deep­er in­to the health­care da­ta they’ve been plumb­ing.

Found­ed by vant chief Vivek Ra­maswamy and helmed by Travis May, the team at Data­vant — now about 65 strong and slat­ed to dou­ble over the next year — has an am­bi­tious goal.

Says CEO May: “We’re try­ing to con­nect the da­ta across the health­care ecosys­tem.”

Re­view­ing his own health­care ex­pe­ri­ence, May counts mul­ti­ple sources that each hold da­ta on his health record. They in­clude maybe a dozen dif­fer­ent doc­tors, 8 pay­ers, a va­ri­ety of phar­ma­cies, a 23andMe ac­count — maybe a cou­ple of hun­dred dif­fer­ent in­sti­tu­tions in to­tal that have a snap­shot of his da­ta. Data­vant is look­ing to tap all those — or as many as pos­si­ble — to as­sem­ble a com­plete pro­file drawn from the da­ta.

Back­ing them on this round is lead in­vestor Trans­for­ma­tion Cap­i­tal, along with John­son & John­son In­no­va­tion — JJDC and Cigna Ven­tures. Ra­maswamy’s Roivant and Flex Cap­i­tal came back to con­tribute to the round, bring­ing the to­tal raised so far to $83 mil­lion.

For years, says May, the first big ques­tion that phar­ma com­pa­nies asked of the da­ta an­a­lyt­ics crowd was: How big is my drug’s mar­ket share? Those da­ta are now ac­cu­rate, but if you col­lect da­ta from hun­dreds or thou­sands of sources, and de-iden­ti­fy the da­ta by name, the in­ter­ro­ga­tion gets more in­ter­est­ing.

“What’s big now is try­ing to con­nect re­al world ev­i­dence with clin­i­cal tri­al da­ta,” says the CEO.

The chal­lenge of tri­al da­ta, he adds, is that it is a se­vere­ly lim­it­ed win­dow of in­for­ma­tion. “With holis­tic in­for­ma­tion about the pa­tient, that un­locks a much bet­ter tri­al de­sign in fu­ture.”

There’s more. As Data­vant gath­ers in­for­ma­tion over the years, the CEO says the ques­tions and the an­swers will get more so­phis­ti­cat­ed. And Covid-19 has helped ac­cel­er­ate the whole process, re­quir­ing the use of more da­ta that can be more eas­i­ly gath­ered while al­so spurring de­vel­op­ers to get more in­no­v­a­tive in or­der to work faster— and un­der­stand things bet­ter — than ever dreamed pos­si­ble.

That’s Data­vant’s kind of world.

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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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.

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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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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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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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.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.