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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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Hamza Suria, AnaptysBio CEO

The biotech be­hind Glax­o­SmithK­line's PD-1 just scored a $250M cash deal for roy­al­ties

With Merck and Bristol Myers Squibb still dominating the PD-(L)1 space and the threat of lower-cost options coming from behind, is there still room for GlaxoSmithKline’s checkpoint inhibitor — the seventh to market — to make billions? For Sagard Healthcare Royalty Partners, the answer is yes.

Sagard has plumped down $250 million in cash to buy out the 8% royalty AnaptysBio owns on Jemperli sales below $1 billion.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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