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

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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