David Coman, Science 37 CEO

Sci­ence 37 takes the SPAC short­cut to Nas­daq, land­ing a $235M wind­fall for its push on de­cen­tral­ized tri­als

Sci­ence 37, which bills it­self as a pi­o­neer in the move to de­cen­tral­ized clin­i­cal tri­als, has reached the end of the SPAC trail to Nas­daq.

The life sci com­pa­ny has com­plet­ed its merg­er with LifeSci Ac­qui­si­tion II Corp., a blank check com­pa­ny, that will de­liv­er a $235 mil­lion bonus of cash, less the usu­al slate of fees.

De­cen­tral­ized tri­als have been all the rage in bio­phar­ma, par­tic­u­lar­ly dur­ing the pan­dem­ic as com­pa­nies ad­just­ed to lock­downs and dis­tanc­ing de­mands. But they were trendy even be­fore Covid made them ab­solute­ly nec­es­sary as drug de­vel­op­ers looked for new and bet­ter ways to at­tract a di­verse set of pa­tients for clin­i­cal stud­ies.

In this par­tic­u­lar case, Sci­ence 37 boasts about an “op­er­at­ing sys­tem” that can take de­cen­tral­ized tri­als one or two steps fur­ther away from tri­al sites, de­ploy­ing a net­work of mo­bile nurs­es, telemed­i­cine in­ves­ti­ga­tors, re­mote co­or­di­na­tors and con­nect­ed de­vices to keep pa­tients re­mote. A few weeks ago they inked an al­liance with Roche’s Foun­da­tion Med­i­cine to iden­ti­fy can­cer pa­tients that would be bet­ter served by their tri­al mod­el, look­ing to crack some long-last­ing is­sues with re­cruit­ment that have ham­pered in­ves­ti­ga­tors over the years.

An­drew Mc­Don­ald

The SPAC that of­fered Sci­ence 37 a quick hop to the mar­kets is a sub­sidiary of LifeSci Part­ners, which has branched out as a litany of oth­er LifeSci com­pa­nies — such as LifeSci Ad­vi­sors, LifeSci Ven­ture Part­ners and LifeSci Cap­i­tal. With An­drew Mc­Don­ald at the head of these oth­er firms since 2010 (with the ex­cep­tion of LifeSci Cap­i­tal found­ed in 2014), the for­mer Pfiz­er chemist and biotech an­a­lyst — turned CEO — has ac­quired oth­er com­pa­nies be­fore. Just last year, LifeSci Ac­qui­si­tion Corp merged with Vin­cerx Phar­ma to cre­ate a new on­col­o­gy com­pa­ny, trad­ing un­der the new tick­er sym­bol $VINC.

“The Sci­ence 37 Op­er­at­ing Sys­tem has been proven to ma­te­ri­al­ly ac­cel­er­ate pa­tient en­roll­ment, pro­vide mean­ing­ful­ly high­er pa­tient re­ten­tion, sig­nif­i­cant­ly re­duce pa­tient bur­den and en­able par­tic­i­pa­tion from un­der­served pa­tient pop­u­la­tions. This is all made pos­si­ble through our full-stack, end-to-end tech­nol­o­gy plat­form and sup­port­ed by spe­cial­ized pa­tient com­mu­ni­ties, telemed­i­cine in­ves­ti­ga­tors, mo­bile nurs­es, and re­mote co­or­di­na­tors,” said Sci­ence 37 CEO David Co­man. “The ad­di­tion­al cap­i­tal from this trans­ac­tion will help us de­liv­er on our vi­sion to be the cat­e­go­ry-defin­ing op­er­at­ing sys­tem that pow­ers every clin­i­cal tri­al as the in­dus­try shifts to more ag­ile tri­al de­signs.”

Co­man now jumps on to a board in­clud­ing:

Rob Faulkn­er, man­ag­ing di­rec­tor at Red­mile Group, as chair­man; John Hub­bard, for­mer CEO at Bio­clin­i­ca and for­mer SVP and world­wide head of de­vel­op­ment op­er­a­tions at Pfiz­er; Bhooshi de Sil­va, SVP, glob­al head of cor­po­rate de­vel­op­ment, strat­e­gy and ven­tures, at PPD, Adam Goul­burn, part­ner at Lux Cap­i­tal; Neil Ti­wari, part­ner of pri­vate health­care ven­tures at Mag­ne­tar Cap­i­tal; and up­on ap­proval, Emi­ly Rollins, for­mer part­ner of De­loitte & Touche.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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