GSK, Sanofi en­list in a big ge­nomics project aim­ing to map genes of half a mil­lion Finns

Sev­er­al Eu­ro­pean coun­tries, in­clud­ing Ice­land and the Nether­lands, have an­a­lyzed ge­nom­ic in­for­ma­tion to study their pop­u­lace. Two years ago, Fin­land be­gan its very own large scale pub­lic-pri­vate ge­nomics project – aimed at map­ping the genomes of 500,000 cit­i­zens (or rough­ly 9% of the coun­try’s pop­u­la­tion) to de­code the ori­gins of dis­ease for pre­ven­tion, di­ag­no­sis and treat­ment. GSK and Sanofi have now joined the ef­fort, bring­ing the to­tal num­ber of phar­ma­ceu­ti­cal part­ners to nine.

The project, called FinnGen, uti­lizes blood sam­ples from biobanks to chart ge­nom­ic da­ta and then an­a­lyzes it with in­for­ma­tion from na­tion­al health records. It in­cludes the par­tic­i­pa­tion of both acad­e­mia and in­dus­try, such as the Finnish de­part­ment of health, hos­pi­tals, uni­ver­si­ties as well as 7 oth­er phar­ma com­pa­nies: Ab­b­Vie, As­traZeneca, Bio­gen, Cel­gene, Roche’s Genen­tech, Mer­ck and Pfiz­er. As of De­cem­ber 2018, 108,000 new biobank sam­ples — in­clud­ing more than 15,000 can­cer pa­tients and over 30,000 pa­tients with car­diometa­bol­ic dis­eases — had been col­lect­ed, ac­cord­ing to an an­nounce­ment ear­li­er this week.

The Fin­ish project, led by the Uni­ver­si­ty of Helsin­ki, us­es a ge­nom­ic map­ping ap­proach called genome-wide as­so­ci­a­tion study (GWAS) geno­typ­ing, which is es­sen­tial­ly de­signed to iden­ti­fy com­mon vari­ants that con­tribute to com­mon dis­eases. These com­mon vari­ants are usu­al­ly lo­cat­ed in re­gions of the chro­mo­some that don’t code for spe­cif­ic func­tion­al pro­teins. Mean­while, Eng­land’s genome project us­es a more com­pre­hen­sive, al­beit slow­er, ap­proach called whole genome se­quenc­ing. This strat­e­gy look in­to re­gions of the chro­mo­some that code for func­tion­al pro­teins and pin­point mu­ta­tions that can have a greater im­pact on dis­ease.

Eng­land’s flag­ship genome project was an­nounced in 2013 and five years lat­er the tar­get of se­quenc­ing 100,000 whole genomes from NHS pa­tients with rare dis­eases, and their fam­i­lies, as well as pa­tients with com­mon can­cers was achieved. How­ev­er, last Oc­to­ber the UK gov­ern­ment an­nounced the project would be ex­pand­ed to se­quence 1 mil­lion whole genomes in the com­ing five years.

Ge­nomics Eng­land has al­so been work­ing with com­pa­nies who fo­cus on drug dis­cov­ery, phar­ma­ceu­ti­cal de­vel­op­ment and da­ta analy­sis to put this ge­nom­ic da­ta to use. Their in­dus­try part­ners in­clude Google, Mi­crosoft and Iqvia, in ad­di­tion to the usu­al phar­ma sus­pects, such as As­traZeneca, GSK, Roche and Take­da.

In De­cem­ber As­traZeneca sharp­ened its fo­cus on ge­nomics by pour­ing its R&D heft in­to a new cen­ter in part­ner­ship with Can­cer Re­search UK, to de­vel­op per­son­al­ized can­cer drugs. Fel­low British drug­mak­er GSK $GSK, has tied up with 23andMe to gain ac­cess to the lat­ter’s data­base — to look for dis­ease rel­e­vant genes. Across the At­lantic, Re­gen­eron $REGN has carved out its own ge­net­ics cen­tre, Am­gen $AMGN has sharp­ened its abil­i­ty to iden­ti­fy and val­i­date dis­ease tar­gets with its in­vest­ment in Ox­ford Nanopore Tech­nolo­gies and ac­qui­si­tion of de­CODE ge­net­ics, while Ver­tex $VRTX has part­nered with UK-based Ge­nomics plc on their plat­form for ge­net­ics and ma­chine learn­ing.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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