Tri­al soft­ware group rais­es $45M to push de­cen­tral­ized stud­ies; $120M SPAC makes its way to Nas­daq

Af­ter watch­ing the en­tire clin­i­cal tri­al process go through a ma­jor makeover dur­ing the pan­dem­ic, an­oth­er soft­ware out­fit is mak­ing a play to help de­vel­op­ers get on the cut­ting edge of tri­al de­sign and de­cen­tral­ized ex­e­cu­tion.

Hobo­ken, NJ-based Cas­tor has just raised $45 mil­lion to fund de­vel­op­ment of soft­ware in­tend­ed to scale up their “di­rect-to-pa­tients” ap­proach glob­al­ly. This new round brings their to­tal fund­ing to $65 mil­lion.

Eight Roads Ven­tures and F-Prime Cap­i­tal led the round, with par­tic­i­pa­tion from ex­ist­ing in­vestors Two Sig­ma Ven­tures and Inkef Cap­i­tal.

The big idea here is that pa­tients can en­roll in tri­als on­line, up­load­ing da­ta as they go through the study and cut­ting out the old re­liance on brick-and-mor­tar tri­al sites. Eas­i­er in­ter­ac­tions with pa­tients should go a long way to im­prove the odds of com­plet­ing a tri­al and get­ting it done more ef­fi­cient­ly.

“Cas­tor was cre­at­ed with the mis­sion to help re­searchers glob­al­ly con­duct more ef­fec­tive clin­i­cal tri­als while im­prov­ing the pa­tient ex­pe­ri­ence,” said Cas­tor founder and CEO Derk Arts in a state­ment. “Pri­or­i­tiz­ing the pa­tient and site user ex­pe­ri­ence is par­tic­u­lar­ly im­por­tant to­day, when COVID-19 has fun­da­men­tal­ly changed the na­ture of clin­i­cal tri­als.” — John Car­roll

JATT Ac­qui­si­tion SPAC is head­ed to Nas­daq

One of the newest life sci­ences SPACs out there is ready for its Nas­daq close­up.

JATT Ac­qui­si­tion, the SPAC from a co-founder of Pathios Ther­a­peu­tics and CEO of Akaza Bio­science and Izana Bio­science, priced Wednes­day morn­ing to the tune of a $120 mil­lion raise. The blank-check com­pa­ny will launch at $10 per share with the tick­er $JAT­TU.

Someit Sid­hu

The SPAC is run by Someit Sid­hu, a rel­a­tive un­known who be­fore his biotech ex­pe­ri­ence worked at the con­sult­ing firm McK­in­sey, where he cut his teeth ad­vis­ing un­named glob­al phar­ma com­pa­nies. He al­so holds a de­gree from Ox­ford Med­ical School with an em­pha­sis on car­di­ol­o­gy and gen­er­al surgery.

Al­so on the team are Tauhid Ali, a for­mer Take­da vet who launched three biotechs out of the phar­ma’s in­cu­ba­tor, and Arnout Ploos van Am­s­tel, for­mer head of No­var­tis’ im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy fran­chis­es. — Max Gel­man

Alkeus nabs BTD for de­gen­er­a­tive eye dis­ease

Alkeus Phar­ma­ceu­ti­cals has won a new en­dorse­ment from the FDA.

The Somerville, MA-based biotech an­nounced Wednes­day the agency has be­stowed a Break­through Ther­a­py Des­ig­na­tion up­on its ex­per­i­men­tal drug ALK-001 to treat Star­gardt dis­ease. De­signed to be tak­en once a day, the can­di­date is a chem­i­cal­ly-mod­i­fied form of vi­t­a­min A de­vel­oped for mul­ti­ple reti­nal de­gen­er­a­tive dis­eases, the com­pa­ny said. Alkeus’ BTD came af­ter a Phase II ran­dom­ized place­bo study.

The biotech es­ti­mates that be­tween 40,000 and 60,000 pa­tients cur­rent­ly live with the dis­ease, and al­most every­one di­ag­nosed ul­ti­mate­ly be­comes legal­ly blind. — Max Gel­man

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.