Phar­ma gi­ants back a leader in vir­tu­al clin­i­cal tri­als as Covid-19 blights sites

While tra­di­tion­al tri­al sites are un­der enor­mous pres­sure amid the Covid-19 pan­dem­ic, 3 phar­ma gi­ants con­tin­ue to back a leader in vir­tu­al clin­i­cal tri­als.

Los An­ge­les-based Sci­ence 37 closed a $40 mil­lion fund­ing round on Fri­day, with in­vest­ments from No­var­tis, Am­gen and Sanofi Ven­tures. Lux Cap­i­tal, Red­mile Group and PPD led the round, and LifeSci Ven­tures and Mubadala Ven­tures joined in for the first time.

The funds will sup­port Sci­ence 37’s tech plat­form, which it us­es to con­nect clin­i­cal tri­al par­tic­i­pants to re­searchers via tele­health and a net­work of home-health nurs­es. Pa­tients can pick up a cell phone to par­tic­i­pate, rather than risk­ing a vis­it to a clin­i­cal site  — many of which are op­er­at­ing un­der re­stric­tions dur­ing the pan­dem­ic.

David Co­man

“The Sci­ence 37 mis­sion to de­moc­ra­tize clin­i­cal re­search by bring­ing tri­als di­rect­ly to the pa­tients is not on­ly the right thing to do, but it al­so has had a clear, mea­sur­able im­pact on spon­sors’ abil­i­ty to ac­cess a more di­verse pa­tient pop­u­la­tion, ac­cel­er­ate re­search, and bring new med­i­cines to the mar­ket faster,” CEO David Co­man said in a state­ment.

No­var­tis joined the tech com­pa­ny’s $29 mil­lion fi­nanc­ing round a few years ago, and short­ly af­ter launched 10 vir­tu­al clin­i­cal tri­als in der­ma­tol­ogy, neu­ro­science and can­cer. At the time, it al­ready had var­i­ous site­less tri­als go­ing, in­clud­ing ones for clus­ter headaches and NASH.

Jonathan Cotliar

Not all Sci­ence 37 tri­als are ful­ly re­mote. The com­pa­ny’s mod­el al­lows re­searchers to opt for a vir­tu­al arm to tra­di­tion­al sites. But the pan­dem­ic has on­ly ex­ac­er­bat­ed the need for re­mote tri­als. This April, Ad­var­ra and In­no­vo Re­search both part­nered with Sci­ence 37 to ad­vance Covid-19-re­lat­ed tri­als.

“We are see­ing a sig­nif­i­cant and grow­ing num­ber of cas­es where clin­i­cal tri­al par­tic­i­pants are re­fus­ing to vis­it hos­pi­tals or lo­cal clin­ics for fear that they could be ex­posed to COVID-19,” Sci­ence 37 CMO Jonathan Cotliar said in a state­ment.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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